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Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C Liver Disease

Primary Purpose

Hepatitis C, Chronic

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

eltrombopag

placebo

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring hepatitis C, ribavirin, Hepatitis C-related thrombocytopenia, thrombopoietin, peginterferon alfa-2b, platelets

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female subjects, >18 years Evidence of chronic hepatitis C virus (HCV) infection Subjects who are appropriate candidates for peginterferon (pegIFN) and ribavirin antiviral therapy A platelet count of <75,000/mcL Haemoglobin >11.0g/dL for men or >10.0g/dL for women Absolute neutrophil count (ANC) >750/mm3 and no history of infections associated with neutropenia Creatinine clearance >50mL/minute All fertile males and females must use two forms of effective contraception between them during treatment and during the 24 weeks after treatment end Subject is able to understand, consent and comply with protocol requirements and instructions and is likely to complete the study as planned

Exclusion criteria:

Non-responders to previous treatment with pegIFN and ribavirin who failed to achieve a sustained virologic response (SVR) for reasons other than thrombocytopenia, despite an optimal course (dose and duration) of combination therapy with pegIFN and ribavirin Decompensated liver disease, e.g. Child-Pugh score >6 or history of ascites or hepatic encephalopathy or current evidence of ascites Known hypersensitivity, intolerance or allergy to interferon (IFN), ribavirin, eltrombopag or any of their ingredients Serious cardiac, cerebrovascular, or pulmonary disease that would preclude treatment with pegIFN and ribavirin

Subjects with a history of any one of the following:

Suicide attempt or hospitalisation for depression in the past 5 years Any current severe or poorly controlled psychiatric disorder

The following subjects are eligible for study participation, but must be assessed and followed (if recommended) by a mental health professional:

Subjects who have had a severe or poorly controlled psychiatric disorder more than 6 months ago but less than 5 years ago
Seizure disorder that has not been well controlled History of clinically significant bleeding from oesophageal or gastric varices Subjects with haemoglobinopathies, e.g. sickle cell anaemia, thalassemia major Any prior history of arterial or venous thrombosis AND two or more of the following risk factors: hereditary thrombophilic disorders (e.g. Factor V Leiden, ATIII deficiency, etc), hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension or cancer Pre-existing cardiac disease (New York Heart Association (NYHA) Grade III/IV), or arrhythmias known to involve the risk of thromboembolic events, or corrected QT interval (QTc) >450 msec Evidence of hepatocellular carcinoma Laboratory evidence of infection with human immunodeficiency virus (HIV) or active Hepatitis B Virus (HBV) infection Any disease condition associated with active bleeding or requiring anticoagulation with heparin or warfarin Therapy with any anti-neoplastic or immuno-modulatory treatment <6 months prior to the first dose of eltrombopag.

Subjects who have had a malignancy diagnosed and/or treated within the past 5 years, except for subjects with localised basal or squamous cell carcinoma treated by local excision or subjects with malignancies who have been adequately treated and, in the opinion of the oncologist, have an excellent chance of cancer-free survival Pregnant or nursing women Males with a female partner who is pregnant History of alcohol/drug abuse or dependence within 6 months of the study start (unless participating in a controlled rehabilitation programme) Treatment with an investigational drug or IFN within 30 days or 5 half-lives (whichever is longer) of the screening visit History of platelet clumping that prevents reliable measurement of platelet counts History of major organ transplantation with an existing functional graft Thyroid dysfunction not adequately controlled Subjects planning to have cataract surgery Evidence of portal vein thrombosis on abdominal imaging within 3 months of the baseline visit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

eltrombopag

placebo

Arm Description

active treatment arm

placebo control arm

Outcomes

Primary Outcome Measures

Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase

Participants with SVR are defined as those with non-detectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at the end of treatment and all subsequent planned visits up to 24 weeks post-completion of the treatment period of the DB Phase.

Secondary Outcome Measures

Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 100 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase

Participants were assessed for a shift from a baseline platelet count of <75 Gi/L to a count >=100 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw.

Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase

In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was <100 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained <100 Gi/L. Participants who achieved platelet counts >=100 Gi/L when receiving any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.

Median Platelet Count at the Indicated Time Points During the OL Phase

Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.

Median Platelet Count at the Indicated Time Points During the DB Phase

Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy

The minimum platelet count with antiviral therapy was categorized as follows: <25 Gi/L; >=25 to <50 Gi/L; >=50 to <90 Gi/L; >=90 to <150 Gi/L; >=150 Gi/L to <200 Gi/L; >=200 Gi/L to <400 Gi/L; and >=400 Gi/L.

Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase

RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.

Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase

EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. cEVR is defined as undetectable HCV RNA after 12 weeks of antiviral treatment.

Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase

ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment.

Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase

Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). When possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, when dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.

Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase

Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.

Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase

The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (µg). For peginterferon dose modification, downward adjustments in one-level increments were considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 µg. When dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 µg was generally adequate. In some cases, a dose reduction to 90 µg or 45 µg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.

Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase

The following participants were considered to have discontinued antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3.

Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3)

There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. IL28B genotype distribution by response to antiviral therapy (SVR/RVR responders: those who achieved SVR/RVR; SVR/RVR non-responders: those who did not achieve SVR/RVR) was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.

Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS)

Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.

Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS

Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.

Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication

Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.

Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase

Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.

Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase

Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS and a NCS change from baseline in ECG status, as determined by the Investigator, was reported. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. "Not applicable" indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS.

Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase

Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase

Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase

The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase

The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Full Information

NCT ID

NCT00529568

First Posted

September 12, 2007

Last Updated

October 10, 2013

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00529568

Brief Title

Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C Liver Disease

Official Title

Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2b Plus Ribavirin)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).

6. Conditions and Keywords

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

Hepatitis C, Chronic

Keywords

hepatitis C, ribavirin, Hepatitis C-related thrombocytopenia, thrombopoietin, peginterferon alfa-2b, platelets

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

759 (Actual)

8. Arms, Groups, and Interventions

Arm Title

eltrombopag

Arm Type

Experimental

Arm Description

active treatment arm

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

placebo control arm

Intervention Type

Drug

Intervention Name(s)

eltrombopag

Intervention Description

double-blind active treatment daily oral administation at dose of 25, 50, 75, or 100 mg

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

double-blind matched placebo control daily oral administration

Primary Outcome Measure Information:

Title

Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase

Description

Time Frame

From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Secondary Outcome Measure Information:

Title

Description

Time Frame

From Baseline up to Week 9 in the OL Phase

Title

Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase

Description

Time Frame

From Baseline up to Week 9 in the OL Phase

Title

Median Platelet Count at the Indicated Time Points During the OL Phase

Description

Time Frame

OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)

Title

Median Platelet Count at the Indicated Time Points During the DB Phase

Description

Time Frame

DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

Title

Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy

Description

Time Frame

From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Title

Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase

Description

Time Frame

From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Title

Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase

Description

Time Frame

From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Title

Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase

Description

Time Frame

From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Title

Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase

Description

Time Frame

From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Title

Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase

Description

Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.

Time Frame

From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Title

Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase

Description

Time Frame

From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Title

Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase

Description

Time Frame

From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Title

Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3)

Description

Time Frame

From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Title

Description

Time Frame

From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Title

Description

Time Frame

From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Title

Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication

Description

Time Frame

From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Title

Description

Time Frame

DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)

Title

Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase

Description

Time Frame

End of Treatment (up to Week 52); and 24-week FU (up to Week 72)

Title

Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase

Description

Time Frame

Title

Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase

Description

Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Time Frame

Title

Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase

Description

The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Time Frame

Title

Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase

Description

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female subjects, >18 years Evidence of chronic hepatitis C virus (HCV) infection Subjects who are appropriate candidates for peginterferon (pegIFN) and ribavirin antiviral therapy A platelet count of <75,000/mcL Haemoglobin >11.0g/dL for men or >10.0g/dL for women Absolute neutrophil count (ANC) >750/mm3 and no history of infections associated with neutropenia Creatinine clearance >50mL/minute All fertile males and females must use two forms of effective contraception between them during treatment and during the 24 weeks after treatment end Subject is able to understand, consent and comply with protocol requirements and instructions and is likely to complete the study as planned Exclusion criteria: Non-responders to previous treatment with pegIFN and ribavirin who failed to achieve a sustained virologic response (SVR) for reasons other than thrombocytopenia, despite an optimal course (dose and duration) of combination therapy with pegIFN and ribavirin Decompensated liver disease, e.g. Child-Pugh score >6 or history of ascites or hepatic encephalopathy or current evidence of ascites Known hypersensitivity, intolerance or allergy to interferon (IFN), ribavirin, eltrombopag or any of their ingredients Serious cardiac, cerebrovascular, or pulmonary disease that would preclude treatment with pegIFN and ribavirin Subjects with a history of any one of the following: Suicide attempt or hospitalisation for depression in the past 5 years Any current severe or poorly controlled psychiatric disorder The following subjects are eligible for study participation, but must be assessed and followed (if recommended) by a mental health professional: Subjects who have had a severe or poorly controlled psychiatric disorder more than 6 months ago but less than 5 years ago Seizure disorder that has not been well controlled History of clinically significant bleeding from oesophageal or gastric varices Subjects with haemoglobinopathies, e.g. sickle cell anaemia, thalassemia major Any prior history of arterial or venous thrombosis AND two or more of the following risk factors: hereditary thrombophilic disorders (e.g. Factor V Leiden, ATIII deficiency, etc), hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension or cancer Pre-existing cardiac disease (New York Heart Association (NYHA) Grade III/IV), or arrhythmias known to involve the risk of thromboembolic events, or corrected QT interval (QTc) >450 msec Evidence of hepatocellular carcinoma Laboratory evidence of infection with human immunodeficiency virus (HIV) or active Hepatitis B Virus (HBV) infection Any disease condition associated with active bleeding or requiring anticoagulation with heparin or warfarin Therapy with any anti-neoplastic or immuno-modulatory treatment <6 months prior to the first dose of eltrombopag. Subjects who have had a malignancy diagnosed and/or treated within the past 5 years, except for subjects with localised basal or squamous cell carcinoma treated by local excision or subjects with malignancies who have been adequately treated and, in the opinion of the oncologist, have an excellent chance of cancer-free survival Pregnant or nursing women Males with a female partner who is pregnant History of alcohol/drug abuse or dependence within 6 months of the study start (unless participating in a controlled rehabilitation programme) Treatment with an investigational drug or IFN within 30 days or 5 half-lives (whichever is longer) of the screening visit History of platelet clumping that prevents reliable measurement of platelet counts History of major organ transplantation with an existing functional graft Thyroid dysfunction not adequately controlled Subjects planning to have cataract surgery Evidence of portal vein thrombosis on abdominal imaging within 3 months of the baseline visit

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

35294-0005

Country

United States

Facility Name

GSK Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85750

Country

United States

Facility Name

GSK Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

GSK Investigational Site

City

Arcadia

State/Province

California

ZIP/Postal Code

91007

Country

United States

Facility Name

GSK Investigational Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

GSK Investigational Site

City

Lynwood

State/Province

California

ZIP/Postal Code

90262

Country

United States

Facility Name

GSK Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

GSK Investigational Site

City

San Clemente

State/Province

California

ZIP/Postal Code

92673

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

San Mateo

State/Province

California

ZIP/Postal Code

94403

Country

United States

Facility Name

GSK Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

GSK Investigational Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

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

Washington

State/Province

District of Columbia

ZIP/Postal Code

20307

Country

United States

Facility Name

GSK Investigational Site

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34209

Country

United States

Facility Name

GSK Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Facility Name

GSK Investigational Site

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96817

Country

United States

Facility Name

GSK Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612-3824

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

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

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

02215

Country

United States

Facility Name

GSK Investigational Site

City

Burlington

State/Province

Massachusetts

ZIP/Postal Code

01805

Country

United States

Facility Name

GSK Investigational Site

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Facility Name

GSK Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

GSK Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

GSK Investigational Site

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39202

Country

United States

Facility Name

GSK Investigational Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63104

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

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

GSK Investigational Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10468

Country

United States

Facility Name

GSK Investigational Site

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

GSK Investigational Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

GSK Investigational Site

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

GSK Investigational Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

GSK Investigational Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

GSK Investigational Site

City

Kinston

State/Province

North Carolina

ZIP/Postal Code

28501

Country

United States

Facility Name

GSK Investigational Site

City

Morganton

State/Province

North Carolina

ZIP/Postal Code

28655

Country

United States

Facility Name

GSK Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74104

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

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033-0850

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

GSK Investigational Site

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

GSK Investigational Site

City

Mountain Home

State/Province

Tennessee

ZIP/Postal Code

37684

Country

United States

Facility Name

GSK Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

GSK Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37205

Country

United States

Facility Name

GSK Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75203

Country

United States

Facility Name

GSK Investigational Site

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555-0435

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

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

Facility Name

GSK Investigational Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

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

Seattle

State/Province

Washington

ZIP/Postal Code

98111

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

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

GSK Investigational Site

City

Randwick

State/Province

New South Wales

ZIP/Postal Code

2031

Country

Australia

Facility Name

GSK Investigational Site

City

Cairns

State/Province

Queensland

ZIP/Postal Code

4870

Country

Australia

Facility Name

GSK Investigational Site

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

GSK Investigational Site

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

GSK Investigational Site

City

Fitzroy

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

GSK Investigational Site

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

GSK Investigational Site

City

Prahran

State/Province

Victoria

ZIP/Postal Code

3181

Country

Australia

Facility Name

GSK Investigational Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

GSK Investigational Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

GSK Investigational Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

GSK Investigational Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

GSK Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

GSK Investigational Site

City

Campinas

State/Province

São Paulo

ZIP/Postal Code

13083-888

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

04023900

Country

Brazil

Facility Name

GSK Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2C8

Country

Canada

Facility Name

GSK Investigational Site

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8V 3P9

Country

Canada

Facility Name

GSK Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 3P4

Country

Canada

Facility Name

GSK Investigational Site

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 7G1

Country

Canada

Facility Name

GSK Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

Facility Name

GSK Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Facility Name

GSK Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

GSK Investigational Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

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

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6H 3M1

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 3J4

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

GSK Investigational Site

City

Hradec Kralove

ZIP/Postal Code

500 12

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Olomouc

ZIP/Postal Code

775 20

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Praha 6

ZIP/Postal Code

169 02

Country

Czech Republic

Facility Name

GSK Investigational Site

City

Cairo

Country

Egypt

Facility Name

GSK Investigational Site

City

Mansoura

ZIP/Postal Code

35516

Country

Egypt

Facility Name

GSK Investigational Site

City

Shebeen El-Kom, Menoufeya

ZIP/Postal Code

35111

Country

Egypt

Facility Name

GSK Investigational Site

City

Besançon

ZIP/Postal Code

25030

Country

France

Facility Name

GSK Investigational Site

City

Bondy

ZIP/Postal Code

93140

Country

France

Facility Name

GSK Investigational Site

City

Dijon cedex

ZIP/Postal Code

21019

Country

France

Facility Name

GSK Investigational Site

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

GSK Investigational Site

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

GSK Investigational Site

City

Marseille Cedex 08

ZIP/Postal Code

13285

Country

France

Facility Name

GSK Investigational Site

City

Orléans

ZIP/Postal Code

45100

Country

France

Facility Name

GSK Investigational Site

City

Paris Cedex 12

ZIP/Postal Code

75571

Country

France

Facility Name

GSK Investigational Site

City

Paris Cedex 13

ZIP/Postal Code

75651

Country

France

Facility Name

GSK Investigational Site

City

Rouen

ZIP/Postal Code

76000

Country

France

Facility Name

GSK Investigational Site

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

GSK Investigational Site

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

GSK Investigational Site

City

Freiburg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

79106

Country

Germany

Facility Name

GSK Investigational Site

City

Heidelberg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

GSK Investigational Site

City

Mannheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

68167

Country

Germany

Facility Name

GSK Investigational Site

City

Stuttgart

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

70197

Country

Germany

Facility Name

GSK Investigational Site

City

Ulm

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

89081

Country

Germany

Facility Name

GSK Investigational Site

City

Deggendorf

State/Province

Bayern

ZIP/Postal Code

94469

Country

Germany

Facility Name

GSK Investigational Site

City

Hof/Saale

State/Province

Bayern

ZIP/Postal Code

95028

Country

Germany

Facility Name

GSK Investigational Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

81377

Country

Germany

Facility Name

GSK Investigational Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

81675

Country

Germany

Facility Name

GSK Investigational Site

City

Regensburg

State/Province

Bayern

ZIP/Postal Code

93049

Country

Germany

Facility Name

GSK Investigational Site

City

Wuerzburg

State/Province

Bayern

ZIP/Postal Code

97080

Country

Germany

Facility Name

GSK Investigational Site

City

Beeskow

State/Province

Brandenburg

ZIP/Postal Code

15848

Country

Germany

Facility Name

GSK Investigational Site

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

Facility Name

GSK Investigational Site

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60596

Country

Germany

Facility Name

GSK Investigational Site

City

Kassel

State/Province

Hessen

ZIP/Postal Code

34127

Country

Germany

Facility Name

GSK Investigational Site

City

Goettingen

State/Province

Niedersachsen

ZIP/Postal Code

37075

Country

Germany

Facility Name

GSK Investigational Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30159

Country

Germany

Facility Name

GSK Investigational Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30625

Country

Germany

Facility Name

GSK Investigational Site

City

Rotenburg (Wuemme)

State/Province

Niedersachsen

ZIP/Postal Code

27356

Country

Germany

Facility Name

GSK Investigational Site

City

Aachen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

52074

Country

Germany

Facility Name

GSK Investigational Site

City

Bochum

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

44787

Country

Germany

Facility Name

GSK Investigational Site

City

Bonn

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

53127

Country

Germany

Facility Name

GSK Investigational Site

City

Dortmund

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

44263

Country

Germany

Facility Name

GSK Investigational Site

City

Duesseldorf

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

40225

Country

Germany

Facility Name

GSK Investigational Site

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45122

Country

Germany

Facility Name

GSK Investigational Site

City

Herne

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

44623

Country

Germany

Facility Name

GSK Investigational Site

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

50937

Country

Germany

Facility Name

GSK Investigational Site

City

Leverkusen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

51375

Country

Germany

Facility Name

GSK Investigational Site

City

Muenster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48143

Country

Germany

Facility Name

GSK Investigational Site

City

Oberhausen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

46045

Country

Germany

Facility Name

GSK Investigational Site

City

Siegen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

57072

Country

Germany

Facility Name

GSK Investigational Site

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55131

Country

Germany

Facility Name

GSK Investigational Site

City

Halle

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06120

Country

Germany

Facility Name

GSK Investigational Site

City

Magdeburg

State/Province

Sachsen-Anhalt

ZIP/Postal Code

39120

Country

Germany

Facility Name

GSK Investigational Site

City

Chemnitz

State/Province

Sachsen

ZIP/Postal Code

09116

Country

Germany

Facility Name

GSK Investigational Site

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04129

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10439

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

10969

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

10676

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

115 27

Country

Greece

Facility Name

GSK Investigational Site

City

Rio, Patras

ZIP/Postal Code

265 04

Country

Greece

Facility Name

GSK Investigational Site

City

Thessaloniki

ZIP/Postal Code

546 42

Country

Greece

Facility Name

GSK Investigational Site

City

Bangalore

ZIP/Postal Code

560054

Country

India

Facility Name

GSK Investigational Site

City

Chennai

ZIP/Postal Code

600 096

Country

India

Facility Name

GSK Investigational Site

City

Hyderabad

ZIP/Postal Code

500082

Country

India

Facility Name

GSK Investigational Site

City

Mumbai

ZIP/Postal Code

400 008

Country

India

Facility Name

GSK Investigational Site

City

Mumbai

ZIP/Postal Code

400 016

Country

India

Facility Name

GSK Investigational Site

City

Mumbai

ZIP/Postal Code

400036

Country

India

Facility Name

GSK Investigational Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

GSK Investigational Site

City

Haifa

ZIP/Postal Code

34362

Country

Israel

Facility Name

GSK Investigational Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

GSK Investigational Site

City

Nazareth

ZIP/Postal Code

16100

Country

Israel

Facility Name

GSK Investigational Site

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

GSK Investigational Site

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

GSK Investigational Site

City

Safed

ZIP/Postal Code

13110

Country

Israel

Facility Name

GSK Investigational Site

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

GSK Investigational Site

City

Catanzaro

State/Province

Calabria

ZIP/Postal Code

88100

Country

Italy

Facility Name

GSK Investigational Site

City

Avellino

State/Province

Campania

ZIP/Postal Code

83100

Country

Italy

Facility Name

GSK Investigational Site

City

Bologna

State/Province

Emilia-Romagna

ZIP/Postal Code

40138

Country

Italy

Facility Name

GSK Investigational Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00133

Country

Italy

Facility Name

GSK Investigational Site

City

Genova

State/Province

Liguria

ZIP/Postal Code

16132

Country

Italy

Facility Name

GSK Investigational Site

City

Brescia

State/Province

Lombardia

ZIP/Postal Code

25123

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20132

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20157

Country

Italy

Facility Name

GSK Investigational Site

City

Bari

State/Province

Puglia

ZIP/Postal Code

70124

Country

Italy

Facility Name

GSK Investigational Site

City

San Giovanni Rotondo (FG)

State/Province

Puglia

ZIP/Postal Code

71013

Country

Italy

Facility Name

GSK Investigational Site

City

Palermo

State/Province

Sicilia

ZIP/Postal Code

90127

Country

Italy

Facility Name

GSK Investigational Site

City

Busan

ZIP/Postal Code

614-735

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Daegu

ZIP/Postal Code

700-721

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Pusan

ZIP/Postal Code

602-739

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

135-720

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Lahore

ZIP/Postal Code

54000

Country

Pakistan

Facility Name

GSK Investigational Site

City

Lahore

ZIP/Postal Code

54600

Country

Pakistan

Facility Name

GSK Investigational Site

City

Chorzow

ZIP/Postal Code

41-500

Country

Poland

Facility Name

GSK Investigational Site

City

Kielce

ZIP/Postal Code

25-317

Country

Poland

Facility Name

GSK Investigational Site

City

Raciborz

ZIP/Postal Code

47-400

Country

Poland

Facility Name

GSK Investigational Site

City

Szczecin

ZIP/Postal Code

71-455

Country

Poland

Facility Name

GSK Investigational Site

City

Warszawa

ZIP/Postal Code

01-201

Country

Poland

Facility Name

GSK Investigational Site

City

Wroclaw

ZIP/Postal Code

51-149

Country

Poland

Facility Name

GSK Investigational Site

City

Ponce

ZIP/Postal Code

00717

Country

Puerto Rico

Facility Name

GSK Investigational Site

City

San Juan

ZIP/Postal Code

00927

Country

Puerto Rico

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

021105

Country

Romania

Facility Name

GSK Investigational Site

City

Constanta

ZIP/Postal Code

900709

Country

Romania

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

107014

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

191167

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Samara

ZIP/Postal Code

443011

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St.Peterburg

ZIP/Postal Code

190103

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Bratislava

ZIP/Postal Code

811 07

Country

Slovakia

Facility Name

GSK Investigational Site

City

Bratislava

ZIP/Postal Code

833 05

Country

Slovakia

Facility Name

GSK Investigational Site

City

Kosice

ZIP/Postal Code

041 66

Country

Slovakia

Facility Name

GSK Investigational Site

City

Martin

ZIP/Postal Code

036 59

Country

Slovakia

Facility Name

GSK Investigational Site

City

Alicante

ZIP/Postal Code

03010

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

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28006

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

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

GSK Investigational Site

City

Palma de Mallorca

ZIP/Postal Code

07010

Country

Spain

Facility Name

GSK Investigational Site

City

Pontevedra

ZIP/Postal Code

36071

Country

Spain

Facility Name

GSK Investigational Site

City

Sabadell (Barcelona)

ZIP/Postal Code

08208

Country

Spain

Facility Name

GSK Investigational Site

City

San Sebastián

ZIP/Postal Code

20014

Country

Spain

Facility Name

GSK Investigational Site

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

Facility Name

GSK Investigational Site

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

GSK Investigational Site

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

GSK Investigational Site

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

GSK Investigational Site

City

Chia-Yi Hsien

ZIP/Postal Code

613

Country

Taiwan

Facility Name

GSK Investigational Site

City

Kaohsiung

ZIP/Postal Code

833

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taiyuan Hsien

ZIP/Postal Code

333

Country

Taiwan

Facility Name

GSK Investigational Site

City

Donetsk

ZIP/Postal Code

83114

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kiev

ZIP/Postal Code

01030

Country

Ukraine

Facility Name

GSK Investigational Site

City

Vinnitsa

ZIP/Postal Code

21021

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

26173631

Citation

Saleh MI, Obeidat AR, Anter HA, Khanfar AA. Eltrombopag dose predictors in thrombocytopenic subjects with hepatitis C virus infection. Clin Exp Pharmacol Physiol. 2015 Oct;42(10):1030-5. doi: 10.1111/1440-1681.12451.

Results Reference

derived

PubMed Identifier

25777337

Citation

Giannini EG, Afdhal NH, Sigal SH, Muir AJ, Reddy KR, Vijayaraghavan S, Elkashab M, Romero-Gomez M, Dusheiko GM, Iyengar M, Vasey SY, Campbell FM, Theodore D. Non-cirrhotic thrombocytopenic patients with hepatitis C virus: Characteristics and outcome of antiviral therapy. J Gastroenterol Hepatol. 2015 Aug;30(8):1301-8. doi: 10.1111/jgh.12942.

Results Reference

derived

PubMed Identifier

24126097

Citation

Afdhal NH, Dusheiko GM, Giannini EG, Chen PJ, Han KH, Mohsin A, Rodriguez-Torres M, Rugina S, Bakulin I, Lawitz E, Shiffman ML, Tayyab GU, Poordad F, Kamel YM, Brainsky A, Geib J, Vasey SY, Patwardhan R, Campbell FM, Theodore D. Eltrombopag increases platelet numbers in thrombocytopenic patients with HCV infection and cirrhosis, allowing for effective antiviral therapy. Gastroenterology. 2014 Feb;146(2):442-52.e1. doi: 10.1053/j.gastro.2013.10.012. Epub 2013 Oct 12.

Results Reference

derived

Learn more about this trial

Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C Liver Disease

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Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C Liver Disease

Hepatitis C, Chronic

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

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