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Safety Study to Assess IV Zanamivir for Treatment of Influenza Infection in Patients Who Are in Hospital

Primary Purpose

Influenza, Human

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

zanamivir aqueous solution

About this trial

This is an interventional treatment trial for Influenza, Human focused on measuring pandemic, seasonal influenza, Influenza B virus, H1N1, zanamivir, Influenza A virus, H1N1 Subtype, Relenza, influenza, neuraminidase inhibitor

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female aged greater than or equal to 6 months of age; a female is eligible to enter and participate in the study if she is:
1. of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or,
2. of child-bearing potential, has a negative pregnancy test at Baseline, and agrees to one of the following methods for avoidance of pregnancy during the study and until the Post-Treatment +23 Days Follow-up Assessment:
Abstinence; or,
Oral contraceptive, either combined or progestogen alone; or,
Injectable progestogen; or,
Implants of levonorgestrel; or,
Estrogenic vaginal ring; or,
Percutaneous contraceptive patches; or
Intrauterine device (IUD) or intrauterine system (IUS) showing that the expected failure rate is less than 1% per year as stated in the IUD or IUS Product Label; or,
Has a male partner who is sterilized; or,
Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository).
Subjects who have confirmed influenza as determined by a positive result in a rapid test for influenza A or influenza B, or a laboratory test for influenza including influenza virus antigen test, virus culture or RT-PCR test. Subjects with negative rapid test result suspected of having influenza can be enrolled following confirmatory testing by RT-PCR, antigen test or culture.
Hospitalized subjects with symptomatic influenza
Subjects who are able to receive their first dose of study medication within seven days of experiencing influenza-like symptoms.
Subjects willing and able to adhere to the procedures stated in the protocol.
Subjects/legally acceptable representative (LAR) of minors and unconscious adults willing and able to give written informed consent to participate in the study (or included as permitted by local regulatory authorities, IRBs/IECs or local laws).
French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
UK subjects and subjects in Spain: Subjects should be in a high dependency or intensive care setting at the time of enrollment and either have severe and progressive illness on approved influenza antivirals, or are considered unsuitable for treatment with approved influenza antivirals.
Subjects who have severe or progressive influenza illness on approved (fully licensed) influenza antivirals, or who are considered unsuitable or inappropriate for treatment with approved influenza antivirals, or who in the opinion of the investigator may benefit from IV zanamivir therapy.

Exclusion Criteria:

Subjects who, in the opinion of the investigator, are not likely to survive the next 48 hours beyond Baseline.
Subjects who require concurrent therapy with another influenza antiviral drug.
Subjects who have participated in a study using an investigational influenza antiviral drug within 30 days prior to Baseline.
Subjects who are known or suspected to be hypersensitive to any component of the study medication.
Subjects who meet the following criteria at Baseline:
ALT greater than or equal to 3xULN and bilirubin greater than or equal to 2xULN or ALT greater than or equal to 5xULN
History of cardiac disease or clinically significant arrhythmia (either on ECG or by history) which, in the opinion of the Investigator, will interfere with the safety of the individual subject.
Child in care (CiC) as defined below:

A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.

The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a CiC does not include a child who is adopted or has an appointed legal guardian.

French subjects: the French subject has participated in any study using an investigational drug during the previous 30 days.
Females who are pregnant (positive urine or serum pregnancy test at Baseline) or are breastfeeding.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

A single arm open-label design has been selected to achieve the primary objective of providing regulatory authorities with safety data on IV zanamivir in an expedited manner. This study design also facilitates the provision of safety data on a real-time basis, if necessary.

Outcomes

Primary Outcome Measures

Number of Participants With Any Adverse Event (AE) Considered to be Related to Study Treatment

Number of Participants With Any Severe or Grade 3/4 AEs

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs that occured during the study were evaluated by the Investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) table for grading the severity of adult and pediatric AEs. Grade 3=severe; Grade 4=potentially life threatening.

Number of Participants With Any Severe or Grade 3/4 Treatment-related AE

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs that occured during the study were evaluated by the Investigator and graded according to the DAIDS table for grading the severity of adult and pediatric AEs. Grade 3=severe; Grade 4=potentially life threatening. All AEs were assesed by the Investigateor as related or not related to the study treatment.

Number of Participants Who Permanently Discontinued the Study Treatment Due to an AE

Number of Participants Who Were Permanently Discontinued From the Study Due to an AE

Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5

Blood samples for laboratory assessments were collected at Baseline (Day [D] 1), Days 3 and 5, and on post-treatment +2 days (if hospitalized) and post-treatment +23 days. Clinical chemistry parameters included alanine aminotransferase (ALT), direct bilirubin (DB), total bilirubin (TB), and creatinine. The number of participants with values that were high (H)/normal (N)/low (L) relative to the normal range at Baseline (D 1) and D 5 for the indicated clinical chemistry parameters are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5

Blood samples for laboratory assessments were collected at Baseline (Day [D] 1), Days 3 and 5, and on post-treatment +2 days (if hospitalized) and post-treatment +23 days. Hematology parameters included hemoglobin, total neutrophils (TN), and white blood cell (WBC) count. The number of participants with values that were high (H)/normal (N)/low (L) relative to the normal range at Baseline (D 1) and D 5 for the indicated hematology parameters are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Toxicities

A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). Clinical chemistry parameters included ALT, TB, and creatinine. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Hematology Toxicities

A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). The hematology parameters included hemoglobin, TN, and WBC count. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Median Heart Rate at Baseline (Day 1) and Day 5

Heart rate was measured at Baseline (Day 1); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Heart rate was assessed once daily during inpatient or outpatient follow-up visits. Heart rate values at Baseline (Day 1) and Day 5 are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).

Median Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline (Day 1) and Day 5

SBP and DBP were measured at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. SBP and DBP were assessed once daily during inpatient or outpatient follow-up visits. SBP and DBP values at Baseline (Day 1) and Day 5 are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).

Median Oxygen Saturation Measured Via Transcutaneous Oximetry (TCPO2) at Baseline (Day 1) and Day 5

TCPO2 is a noninvasive test that directly measures the oxygen level of tissue beneath the skin. Because oxygen is carried to tissues by blood flow in the arteries, TCPO2 is an indirect measure of blood flow. The percent (%) oxygen saturation was measured at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Oxygen saturation was assessed once daily during inpatient follow-up visits. The median oxygen saturation values at Baseline (Day 1) and Day 5 are summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).

Median Respiration Rate at Baseline (Day 1) and Day 5

Respiration rate was measured at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Respiration rate was assessed once daily during inpatient or outpatient follow-up visits. The median respiration rate at Baseline (Day 1) and Day 5 is summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).

Median Body Temperature at Baseline (Day 1) and Day 5

Body temperature was recorded at Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Body temperature was recorded once daily during inpatient or outpatient follow-up visits. Median body temperature at Baseline (Day 1) and Day 5 is summarized. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles).

Number of Participants Assessed as Normal/Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at Baseline (Day 1)

The number of participants with an ECG status of normal and abnormal CS or NCS, as determined by the Investigator, is reported. Normal=all ECG parameters within the accepted normal ranges. Abnormal=ECG findings outside of normal ranges. CS=ECG with a CS abnormality that meets exclusion criteria. NCS=ECG with an abnormality that is not CS nor meets exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles).

Median Corrected QT Interval (QTc) for Heart Rate by Fridericia's Formula (QTcF) and Bazett's Formula (QTcB) at Baseline (Day 1) and Day 5

Twelve-lead ECGs were recorded for the parameters of QTcF and QTcB. The first set of pre-dose ECG values at Baseline (Day 1) and the pre-dose ECG values at Day 5 are presented. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X, X in the category titles). "NA" indicates that data are not available/analysis was not performed. Cohort 1 QTcF and QTcB minimum values of 0.0 were data entry errors that could not be addressed after Data Base Freeze.

Secondary Outcome Measures

Median Time to Virologic Improvement

Time to virologic improvement is defined as a 2-log drop in viral load or undetectable viral ribonucleic acid (RNA) as measured by quantitative reverse transcriptase-polymerase chain reaction (RT-PCR) from nasopharyngeal samples (PCR positive at Baseline). Only those participants available at the specified time points were analyzed.

Median Change From Baseline (Influenza A or B Quantitative PCR, as Appropriate) in Viral Load at the Indicated Time Points

Change from Baseline in viral load was measured from nasopharyngeal swab samples, as determined by RT-PCR (PCR positive at Baseline). Nasopharyngeal swab samples were collected at Baseline (Day 1); Day 2, Day 3, Day 4, Day 5, Day 7, and Day 10; and, only if the participants had continued symptoms and were hospitalized, post-treatment (PT) samples were collected at +2 days, +5 days, +9 days, +16 days, and +23 days. 'PT +23 days' also comprises viral load values at early study withdrawal. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). "NA" indicates that data are not available/analysis was not performed.

Mean Viral Susceptibility to Zanamivir at Baseline (Day 1) and All Post-Baseline Visits Collectively

Viral susceptibility to zanamivir at Baseline and at all post-Baseline visits collectively was assessed by neuraminidase (NA) enzyme inhibition assay. The mean IC50 data are summarized by subtype (A/H1N1, A/H3N2, B) and by visit. IC50 is defined as the concentration of zanamvir required to inhibit NA activity by 50%. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). "NA" indicates that data are not available/analysis was not performed. Please note: pediatric data are pending and will be updated when available.

Number of Participants With Treatment-emergent (TE) Mutations

Viral RNA isolated from participants at Baseline (Day 1) and post-Baseline visits were sequenced to determine the presence of TE neuraminidase (NA) and hemagglutinin (HA) mutations resulting from selective pressure. A mutation was considered to be TE if it was not present at Baseline and was present in the last post-Baseline sample analyzed.These mutations were classified as either known to confer zanamvir resistance or novel mutations with unknown clinical significance. Please note: pediatric data are pending and will be updated when available.

Median Time to Resolution of Individual Vital Signs

Times to return to afebrile status (normal body temperature), normal respiratory status, normal heart rate, and normal systolic blood pressure were assessed. Afebrile status is defined as a temperature <=36.6 axilla, <=37.2 oral, or <=37.7 rectal, core or typanic, degrees Centigrade. A return to normal respiratory status is defined as either: (a) return to pre-morbid oxygen requirement; or (b) return to no need for supplemental oxygen; or (c) respiratory rate <=60, <=40, <=34, <=30, <=24 or <=24 breaths/minute (without supplemental oxygen) for Cohorts 1-6 respectively . A normal HR is defined as <=160, <=150, <=140, <=120, <=100 or <=100 bpm for Cohorts 1-6 respectively, and a normal SBP is defined as >=70, >=74, >=76, >=80, >=90 or >=90 mmHg for Cohorts 1-6 respectively. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles).

Number of Participants With the Indicated Ventilation Status: Modality of Supplemental Oxygen Delivery and Mechanical Ventilation

Ventilation status was measured at Baseline (Day 1); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10; and post-treatment +2 days, +5 days, +9 days, +16 days (assessments to be done if participant remained hospitalized), and +23 days. Ventilation status was assessed once daily during inpatient follow-up visits. The number of participants reported for machine-assisted: extracorporeal membrane oxygenation (ECMO), endotracheal mechanical ventilation, and supplemental oxygen delivery (SOD) at "any time (AT) on study" and at Baseline (Day 1) are summarized.

Duration of Mechanical Ventilation and Supplemental Oxygen Use

Due to the conditional nature of data collection post treatment, the duration of mechanical ventilation and supplemental oxygen use were not determined.

Median Time to Return to Pre-morbid Functional Status

Time to return to pre-morbid functional status was assessed on a 3-point scale (bed rest, limited ambulation, or unrestricted). Only those participants available at the specified time points were analyzed.

Number of Participants With the Indicated Mortality Status at Day 14 and Day 28

The number of participants who died on or before Study Day 14 and Study Day 28 was summarized. Only those participants available at the specified time points were analyzed.

Median Time to Clinical Response (Sustained Resolution) of All Vital Signs (Composite)

Sustained resolution of the following vital signs (composite) was assessed: afebrile status, normal oxygen saturation, normal respiratory status, normal HR, and normal BP. Clinical response is defined as the resolution of at least four of five vital signs within the following resolution criteria, maintained for 24 hours or hospital discharge, whichever occurred first: Temperature in degrees Centigrade (<=36.6 axilla, <=37.2 oral, <=37.7 rectal, core or tympanic); oxygen saturation (>=95%, without supplemental oxygen); respiratory status (return to pre-morbid oxygen requirement, or no need for supplemental oxygen, or respiratory rate <=60, <=40, <=34, <=30, <=24 or <=24 breaths/minute without supplemental oxygen for Cohorts 1-6 respectively); HR (<=160, <=150, <=140, <=120, <=100 or <=100 bpm for Cohorts 1-6 respectively); SBP (>=70, >=74, >=76, >=80, >=90 or >=90 mmHg for Cohorts 1-6 respectively). Only those participants available at the specified time points were analyzed.

Number of Participants With Any AE Categorized as an Influenza Complication

Number of Participants Who Used Any Concomitant Antibiotic Medications for Complications of Influenza

Concomitant medications (prescription and non-prescription) were permitted during the course of the study at the Investigator's discretion (except for prohibited medications: during the treatment period with IV zanamivir, other influenza antiviral drugs were not permitted). The number of participants who were treated with antibiotics for influenza complications was summarized.

Median Duration of Hospitalization and Intensive Care Unit (ICU) Stays

The duration of hospitalization (H) reflects the number of hospitalization days between the date of the first dose of investigational product and the date of discharge. ICU stay includes total duration in ICU and may include days in ICU before entry into the study. For participants with a missing discharge date who were not discharged at the end of the study, the date of discharge was imputed to the last follow-up visit (post-treatment +23 days). Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Geometric Mean Maximum Serum Concentration (Cmax) of Zanamivir at the End of Infusion

The Cmax of zanamivir was evaluated at the end of infusion. Serial blood samples for pharmacokinetic (PK) analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants who were neither on extracorporeal membrane oxygenation (ECMO) nor on continuous renal replacement therapy (CRRT), who were with CLcr >=80 mL/minutes (>=80mL/minute/1.73m^2 for cohorts 1-4) and who received an initial dose (ID) and a maintenance dose (MD) of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. "NA" indicates that data are not available/analysis was not performed.

Geometric Mean Area Under the Serum Drug Concentration-time Curve (AUC) Over a 12-hour Dosing Interval (AUC[0-tau]) and AUC Extrapolated to Infinity (AUC[0-inf]) of Zanamivir

The AUC(0-tau) during the repeat dose interval and AUC(0-inf) for the initial dose were evaluated. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr >=80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. "NA" indicates that data are not available/analysis was not performed.

Geometric Mean Terminal Half Life (t1/2) of Zanamivir

The t1/2 of zanamivir was evaluated. Terminal half life is defined as the time it takes for a substance to lose half of its pharmacologic, physiologic, or radiologic activity. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Day 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr>=80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. "NA" indicates that data are not available/analysis was not performed.

Geometric Mean Serum Clearance of Zanamivir

The serum clearance of zanamivir was evaluated. Clearance is defined as the volume of zanamivir per unit time eliminated from serum. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr >=80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. "NA" indicates that data are not available/analysis was not performed.

Geometric Mean Volume of Distribution (Vd) of Zanamivir

The Vd of zanamivir was evaluated. Volume of distribution is defined as the apparent volume in which zanamivir is distributed. Serial blood samples for PK analysis were collected if possible in conjunction with the initial dose on Day 1 (5-7 serial samples) and over a dosing interval during repeat dosing on Days 3, 4, or 5 (5 serial samples). PK data for all participants with available blood samples were analyzed. PK data for those participants with a CLcr >= 80 mL/minutes (>=80 mL/minute/1.73m^2 for cohorts 1-4) and who received an ID and a MD of 14 mg/kg (6 months to <6 years of age), 12 mg/kg, not to exceed 600 mg (6 to <18 years of age) or 600 mg zanamivir (>=18 years of age) (represented by n=X in the category titles) were summarized. "NA" indicates that data are not available/analysis was not performed.

Full Information

NCT ID

NCT01014988

First Posted

November 16, 2009

Last Updated

February 8, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01014988

Brief Title

Safety Study to Assess IV Zanamivir for Treatment of Influenza Infection in Patients Who Are in Hospital

Official Title

An Open-label, Multi-center, Single Arm Study to Evaluate the Safety and Tolerability of Intravenous Zanamivir in the Treatment of Hospitalized Adult, Adolescent and Pediatric Subjects With Confirmed Influenza Infection

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether zanamivir aqueous solution given by intravenous injection is safe in treating hospitalized patients with confirmed influenza infection. A single arm open-label design has been selected to achieve the primary objective of providing regulatory authorities with safety data on IV zanamivir.

Detailed Description

This study will be an open-label, Phase II, multi-center, single arm study to evaluate the safety and tolerability of IV zanamivir 600mg twice daily for 5 days in hospitalized subjects with laboratory confirmed influenza infection. The initial 5-day treatment course may be extended for up to 5 additional days if viral shedding is determined to be ongoing or if clinical symptoms warrant further treatment with IV zanamivir. Approximately 200 subjects will be enrolled into the study (approximately 150 adult/adolescent subjects and approximately 50 pediatric subjects). Adult (>/= 18 years of age) with normal renal function will receive 600mg per dose. Pediatric (6 months to <13 years)/adolescent (>13 years to <18 years) subjects will receive an age-adjusted, weight-based dose (not to exceed the 600 mg adult dose) intended to provide comparable systemic exposures to 600mg in adults. Subjects with renal impairment will receive an adjusted dose based on calculated creatinine clearance and renal replacement modality. Serum pharmacokinetic assessments will be performed in subjects across all age groups wherever possible. Pharmacokinetic analyses will be conducted, in real-time to the extent possible, when 4 subjects (from whom samples can be obtained) are enrolled in each of the following age cohorts: 6 months to less than 1 year; 1 to less than 2 years, and 2 to less than 6 years to determine the need for pediatric dose adjustments. PK assessments are required in the first 4 subjects enrolled in the 6 months to less than 1 year age cohort, and PK data must be analyzed and IV zanamivir dosage must be reviewed before additional subjects in this age cohort can be enrolled. The study duration is approximately 28 days for subjects whose treatment duration is 5 days, and up to approximately 33 days for subjects whose treatment duration is extended to a maximum of 10 days. The study will consist of Pre-dose Baseline Assessments (Day 1), During Treatment Assessments (Days 1 to 5, and up to Day 10), and Follow-up Assessments on the following days: Post-Treatment +2 +5, +9, +16 and +23 Days. If the first dose of IV zanamivir is administered in the afternoon/evening of Day 1, the twice daily dosing schedule will result in one treatment day encompassing two calendar days. For subjects who have been discharged from hospital, the Post-Treatment +2, +5, +9 and +16 Days Assessments can be made by telephone contact.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Human

Keywords

pandemic, seasonal influenza, Influenza B virus, H1N1, zanamivir, Influenza A virus, H1N1 Subtype, Relenza, influenza, neuraminidase inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

202 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

zanamivir aqueous solution

Intervention Description

Zanamivir aqueous solution 10mg/mL is a clear, colorless, single use, sterile non-preserved preparation containing 10mg of zanamivir in each milliliter, and made isotonic with sodium chloride. It is presented in 20mL clear glass vials closed with rubber stoppers. Each vial contains 200mg of zanamivir.

Primary Outcome Measure Information:

Title

Number of Participants With Any Adverse Event (AE) Considered to be Related to Study Treatment

Description

Time Frame

Up to post-treatment (PT) + 23 days

Title

Number of Participants With Any Severe or Grade 3/4 AEs

Description

Time Frame

Up to post-treatment (PT) + 23 days

Title

Number of Participants With Any Severe or Grade 3/4 Treatment-related AE

Description

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs that occured during the study were evaluated by the Investigator and graded according to the DAIDS table for grading the severity of adult and pediatric AEs. Grade 3=severe; Grade 4=potentially life threatening. All AEs were assesed by the Investigateor as related or not related to the study treatment.

Time Frame

Up to post-treatment (PT) + 23 days

Title

Number of Participants Who Permanently Discontinued the Study Treatment Due to an AE

Description

Time Frame

Up to 10 days

Title

Number of Participants Who Were Permanently Discontinued From the Study Due to an AE

Description

Time Frame

Up to post-treatment (PT) + 23 days

Title

Number of Participants With the Indicated Clinical Chemistry Values Relative to the Normal Range at Baseline (Day 1) and Day 5

Description

Time Frame

Baseline (Day 1) and Day 5

Title

Number of Participants With the Indicated Hematology Values Relative to the Normal Range at Baseline (Day 1) and Day 5

Description

Time Frame

Baseline (Day 1) and Day 5

Title

Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Toxicities

Description

Time Frame

Up to post-treatment (PT) + 23 days

Title

Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Hematology Toxicities

Description

A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). The hematology parameters included hemoglobin, TN, and WBC count. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the last pre-treatment value collected. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Time Frame

Up to post-treatment (PT) + 23 days

Title

Median Heart Rate at Baseline (Day 1) and Day 5

Description

Time Frame

Baseline (Day 1) and Day 5

Title

Median Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline (Day 1) and Day 5

Description

Time Frame

Baseline (Day 1) and Day 5

Title

Median Oxygen Saturation Measured Via Transcutaneous Oximetry (TCPO2) at Baseline (Day 1) and Day 5

Description

Time Frame

Baseline (Day 1) and Day 5

Title

Median Respiration Rate at Baseline (Day 1) and Day 5

Description

Time Frame

Baseline (Day 1) and Day 5

Title

Median Body Temperature at Baseline (Day 1) and Day 5

Description

Time Frame

Baseline (Day 1) and Day 5

Title

Number of Participants Assessed as Normal/Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at Baseline (Day 1)

Description

Time Frame

Baseline (Day 1)

Title

Median Corrected QT Interval (QTc) for Heart Rate by Fridericia's Formula (QTcF) and Bazett's Formula (QTcB) at Baseline (Day 1) and Day 5

Description

Time Frame

Baseline (Day 1) and Day 5

Secondary Outcome Measure Information:

Title

Median Time to Virologic Improvement

Description

Time Frame

Up to post-treatment (PT) + 23 days

Title

Median Change From Baseline (Influenza A or B Quantitative PCR, as Appropriate) in Viral Load at the Indicated Time Points

Description

Time Frame

Baseline (Day 1); Days 2, 3, 4, 5, 7, and 10; and post-treatment +2, +5, +9, +16, +23 days

Title

Mean Viral Susceptibility to Zanamivir at Baseline (Day 1) and All Post-Baseline Visits Collectively

Description

Time Frame

Baseline and up to post-treatment (PT) + 23 days

Title

Number of Participants With Treatment-emergent (TE) Mutations

Description

Time Frame

Baseline and up to post-treatment (PT) + 23 days

Title

Median Time to Resolution of Individual Vital Signs

Description

Time Frame

Up to post-treatment (PT) + 23 days

Title

Number of Participants With the Indicated Ventilation Status: Modality of Supplemental Oxygen Delivery and Mechanical Ventilation

Description

Time Frame

Up to post-treatment (PT) + 23 days

Title

Duration of Mechanical Ventilation and Supplemental Oxygen Use

Description

Due to the conditional nature of data collection post treatment, the duration of mechanical ventilation and supplemental oxygen use were not determined.

Time Frame

Up to discharge from the hospital

Title

Median Time to Return to Pre-morbid Functional Status

Description

Time Frame

Up to post-treatment (PT) + 23 days

Title

Number of Participants With the Indicated Mortality Status at Day 14 and Day 28

Description

The number of participants who died on or before Study Day 14 and Study Day 28 was summarized. Only those participants available at the specified time points were analyzed.

Time Frame

Day 14 and Day 28

Title

Median Time to Clinical Response (Sustained Resolution) of All Vital Signs (Composite)

Description

Time Frame

Up to post-treatment (PT) + 23 days

Title

Number of Participants With Any AE Categorized as an Influenza Complication

Description

Time Frame

Up to post-treatment (PT) + 23 days

Title

Number of Participants Who Used Any Concomitant Antibiotic Medications for Complications of Influenza

Description

Time Frame

Up to post-treatment (PT) + 23 days

Title

Median Duration of Hospitalization and Intensive Care Unit (ICU) Stays

Description

Time Frame

Up to discharge from hospital

Title

Geometric Mean Maximum Serum Concentration (Cmax) of Zanamivir at the End of Infusion

Description

Time Frame

Day 1 and Days 3, 4, or 5

Title

Geometric Mean Area Under the Serum Drug Concentration-time Curve (AUC) Over a 12-hour Dosing Interval (AUC[0-tau]) and AUC Extrapolated to Infinity (AUC[0-inf]) of Zanamivir

Description

Time Frame

Day 1 and Days 3, 4, or 5

Title

Geometric Mean Terminal Half Life (t1/2) of Zanamivir

Description

Time Frame

Day 1 and Days 3, 4, or 5

Title

Geometric Mean Serum Clearance of Zanamivir

Description

Time Frame

Day 1 and Days 3, 4, or 5

Title

Geometric Mean Volume of Distribution (Vd) of Zanamivir

Description

Time Frame

Day 1 and Days 3, 4, or 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female aged greater than or equal to 6 months of age; a female is eligible to enter and participate in the study if she is: of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or, of child-bearing potential, has a negative pregnancy test at Baseline, and agrees to one of the following methods for avoidance of pregnancy during the study and until the Post-Treatment +23 Days Follow-up Assessment: Abstinence; or, Oral contraceptive, either combined or progestogen alone; or, Injectable progestogen; or, Implants of levonorgestrel; or, Estrogenic vaginal ring; or, Percutaneous contraceptive patches; or Intrauterine device (IUD) or intrauterine system (IUS) showing that the expected failure rate is less than 1% per year as stated in the IUD or IUS Product Label; or, Has a male partner who is sterilized; or, Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository). Subjects who have confirmed influenza as determined by a positive result in a rapid test for influenza A or influenza B, or a laboratory test for influenza including influenza virus antigen test, virus culture or RT-PCR test. Subjects with negative rapid test result suspected of having influenza can be enrolled following confirmatory testing by RT-PCR, antigen test or culture. Hospitalized subjects with symptomatic influenza Subjects who are able to receive their first dose of study medication within seven days of experiencing influenza-like symptoms. Subjects willing and able to adhere to the procedures stated in the protocol. Subjects/legally acceptable representative (LAR) of minors and unconscious adults willing and able to give written informed consent to participate in the study (or included as permitted by local regulatory authorities, IRBs/IECs or local laws). French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. UK subjects and subjects in Spain: Subjects should be in a high dependency or intensive care setting at the time of enrollment and either have severe and progressive illness on approved influenza antivirals, or are considered unsuitable for treatment with approved influenza antivirals. Subjects who have severe or progressive influenza illness on approved (fully licensed) influenza antivirals, or who are considered unsuitable or inappropriate for treatment with approved influenza antivirals, or who in the opinion of the investigator may benefit from IV zanamivir therapy. Exclusion Criteria: Subjects who, in the opinion of the investigator, are not likely to survive the next 48 hours beyond Baseline. Subjects who require concurrent therapy with another influenza antiviral drug. Subjects who have participated in a study using an investigational influenza antiviral drug within 30 days prior to Baseline. Subjects who are known or suspected to be hypersensitive to any component of the study medication. Subjects who meet the following criteria at Baseline: ALT greater than or equal to 3xULN and bilirubin greater than or equal to 2xULN or ALT greater than or equal to 5xULN History of cardiac disease or clinically significant arrhythmia (either on ECG or by history) which, in the opinion of the Investigator, will interfere with the safety of the individual subject. Child in care (CiC) as defined below: A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a CiC does not include a child who is adopted or has an appointed legal guardian. French subjects: the French subject has participated in any study using an investigational drug during the previous 30 days. Females who are pregnant (positive urine or serum pregnancy test at Baseline) or are breastfeeding.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85023

Country

United States

Facility Name

GSK Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72202

Country

United States

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

GSK Investigational Site

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06902

Country

United States

Facility Name

GSK Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

GSK Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

GSK Investigational Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

Facility Name

GSK Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

GSK Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

GSK Investigational Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

GSK Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

GSK Investigational Site

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66604

Country

United States

Facility Name

GSK Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

GSK Investigational Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

GSK Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115-5724

Country

United States

Facility Name

GSK Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

GSK Investigational Site

City

St. Paul

State/Province

Minnesota

ZIP/Postal Code

55102

Country

United States

Facility Name

GSK Investigational Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64108

Country

United States

Facility Name

GSK Investigational Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

GSK Investigational Site

City

Butte

State/Province

Montana

ZIP/Postal Code

59701

Country

United States

Facility Name

GSK Investigational Site

City

Camden

State/Province

New Jersey

ZIP/Postal Code

08103

Country

United States

Facility Name

GSK Investigational Site

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11040

Country

United States

Facility Name

GSK Investigational Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

Facility Name

GSK Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28203

Country

United States

Facility Name

GSK Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

GSK Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43205

Country

United States

Facility Name

GSK Investigational Site

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43606

Country

United States

Facility Name

GSK Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19102

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

GSK Investigational Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38103

Country

United States

Facility Name

GSK Investigational Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38105

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

GSK Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

GSK Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84113

Country

United States

Facility Name

GSK Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23249

Country

United States

Facility Name

GSK Investigational Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53201

Country

United States

Facility Name

GSK Investigational Site

City

Garran

State/Province

Australian Capital Territory

ZIP/Postal Code

2606

Country

Australia

Facility Name

GSK Investigational Site

City

Chermside

State/Province

Queensland

ZIP/Postal Code

4032

Country

Australia

Facility Name

GSK Investigational Site

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

GSK Investigational Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

GSK Investigational Site

City

Bedford Park

State/Province

South Australia

ZIP/Postal Code

5043

Country

Australia

Facility Name

GSK Investigational Site

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

GSK Investigational Site

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6000

Country

Australia

Facility Name

GSK Investigational Site

City

Subiaco

State/Province

Western Australia

ZIP/Postal Code

6008

Country

Australia

Facility Name

GSK Investigational Site

City

Sao Paulo

State/Province

São Paulo

ZIP/Postal Code

01308060

Country

Brazil

Facility Name

GSK Investigational Site

City

Rio de Janeiro

ZIP/Postal Code

21941-590

Country

Brazil

Facility Name

GSK Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 0J9

Country

Canada

Facility Name

GSK Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3K 6R8

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X5

Country

Canada

Facility Name

GSK Investigational Site

City

Chicoutimi

State/Province

Quebec

ZIP/Postal Code

G7H 5H6

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1C5

Country

Canada

Facility Name

GSK Investigational Site

City

Quebec

ZIP/Postal Code

G1V 4G2

Country

Canada

Facility Name

GSK Investigational Site

City

Bron cedex

ZIP/Postal Code

69677

Country

France

Facility Name

GSK Investigational Site

City

Grenoble cedex 9

ZIP/Postal Code

38043

Country

France

Facility Name

GSK Investigational Site

City

Limoges cedex

ZIP/Postal Code

87042

Country

France

Facility Name

GSK Investigational Site

City

Nancy cedex

ZIP/Postal Code

54035

Country

France

Facility Name

GSK Investigational Site

City

Nice

ZIP/Postal Code

06200

Country

France

Facility Name

GSK Investigational Site

City

Nîmes cedex 9

ZIP/Postal Code

30029

Country

France

Facility Name

GSK Investigational Site

City

Orléans cedex 2

ZIP/Postal Code

45067

Country

France

Facility Name

GSK Investigational Site

City

Paris cedex 14

ZIP/Postal Code

75679

Country

France

Facility Name

GSK Investigational Site

City

Paris

ZIP/Postal Code

75018

Country

France

Facility Name

GSK Investigational Site

City

Tours cedex 9

ZIP/Postal Code

37044

Country

France

Facility Name

GSK Investigational Site

City

Shatin

Country

Hong Kong

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

830-8543

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

062-0931

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

247-8533

Country

Japan

Facility Name

GSK Investigational Site

City

Osaka

ZIP/Postal Code

534-0021

Country

Japan

Facility Name

GSK Investigational Site

City

Osaka

ZIP/Postal Code

596-8522

Country

Japan

Facility Name

GSK Investigational Site

City

Yamanashi

ZIP/Postal Code

400-8506

Country

Japan

Facility Name

GSK Investigational Site

City

Bergen

ZIP/Postal Code

5021

Country

Norway

Facility Name

GSK Investigational Site

City

Trondheim

ZIP/Postal Code

7030

Country

Norway

Facility Name

GSK Investigational Site

City

Ekaterinburg

ZIP/Postal Code

620102

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Smolensk

ZIP/Postal Code

214006

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Middelburg

State/Province

Mpumalanga

ZIP/Postal Code

1055

Country

South Africa

Facility Name

GSK Investigational Site

City

Bellville

ZIP/Postal Code

7530

Country

South Africa

Facility Name

GSK Investigational Site

City

Observatory

ZIP/Postal Code

7925

Country

South Africa

Facility Name

GSK Investigational Site

City

Panorama

ZIP/Postal Code

7500

Country

South Africa

Facility Name

GSK Investigational Site

City

Rondebosch

ZIP/Postal Code

7700

Country

South Africa

Facility Name

GSK Investigational Site

City

Tygerberg

ZIP/Postal Code

7505

Country

South Africa

Facility Name

GSK Investigational Site

City

Worcester

ZIP/Postal Code

6850

Country

South Africa

Facility Name

GSK Investigational Site

City

(Móstoles) Madrid

ZIP/Postal Code

28935

Country

Spain

Facility Name

GSK Investigational Site

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

GSK Investigational Site

City

Getafe/Madrid

ZIP/Postal Code

28905

Country

Spain

Facility Name

GSK Investigational Site

City

L'Hospitalet de Llobregat

ZIP/Postal Code

08907

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

GSK Investigational Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

GSK Investigational Site

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

GSK Investigational Site

City

Glasgow

State/Province

Lanarkshire

ZIP/Postal Code

G11 6NT

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Liverpool

State/Province

Merseyside

ZIP/Postal Code

L7 8XP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Livingston

State/Province

West Lothian

ZIP/Postal Code

EH54 6PP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Bristol

ZIP/Postal Code

BS2 8AE

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Bristol

ZIP/Postal Code

BS2 8HW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Cardiff

ZIP/Postal Code

CF14 4XW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Leeds

ZIP/Postal Code

LS1 3EX

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Leicester

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Leicester

ZIP/Postal Code

LE3 9QP

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

NW1 2BU

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Oxford

ZIP/Postal Code

OX3 9DU

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

PubMed Identifier

23983212

Citation

Marty FM, Man CY, van der Horst C, Francois B, Garot D, Manez R, Thamlikitkul V, Lorente JA, Alvarez-Lerma F, Brealey D, Zhao HH, Weller S, Yates PJ, Peppercorn AF. Safety and pharmacokinetics of intravenous zanamivir treatment in hospitalized adults with influenza: an open-label, multicenter, single-arm, phase II study. J Infect Dis. 2014 Feb 15;209(4):542-50. doi: 10.1093/infdis/jit467. Epub 2013 Aug 27.

Results Reference

derived

Links:

URL

http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm100228.htm

Description

FDA information on Influenza (Flu) antiviral drugs and related information

URL

http://www.cdc.gov/h1n1flu/

Description

Centers For Disease Control and Prevention 2009 H1N1 flu information

URL

http://www.cdc.gov/flu/

Description

Centers For Disease Control and Prevention seasonal flu information

Available IPD and Supporting Information:

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113678

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113678

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113678

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113678

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113678

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113678

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113678

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Safety Study to Assess IV Zanamivir for Treatment of Influenza Infection in Patients Who Are in Hospital

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Safety Study to Assess IV Zanamivir for Treatment of Influenza Infection in Patients Who Are in Hospital

Influenza, Human

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial