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A Study of the Safety and Efficacy of A-60444 in Adults With Respiratory Syncytial Virus (RSV) Infection Following HSCT

Primary Purpose

Respiratory Syncytial Virus Infections

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
A-60444
Sponsored by
Arrow Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus Infections focused on measuring RSV, HSCT, HEMATOPOIETIC STEM CELL TRANSPL

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients diagnosed with RSV infection who have had a stem cell transplant. Female patients must be of non-childbearing potential or have a negative pregnancy test prior to study start and be deemed not at risk of becoming pregnant. Females of non-childbearing potential are defined as women who have had a hysterectomy, bilateral oophorectomy, tubal ligation, or who have been post-menopausal for at least two years; or are considered to be sterile due to recent chemotherapy. Aged between 18 and 65 years. Patients who have given their written informed consent to participate in the study. Patients who are willing and able to comply with the protocol and study procedures. Exclusion Criteria: Patients who have received an investigational drug within one month preceding the start of dosing. Patients who have a documented history of allergy to benzodiazepines. Patients with significant hepatic impairment (alanine transaminase [ALT] more than 5 x upper level of normal [ULN], total bilirubin more than 3 x ULN). Biochemistry data collected four weeks prior to screening is acceptable. Patients, who in the opinion of their general practitioner or the Investigator, should not participate in the study.

Sites / Locations

  • Stephen MacKinnon

Outcomes

Primary Outcome Measures

Reduction of viral load over time:
2-log reduction (by quantitative real time reverse transcription polymerase chain reaction [rtRT PCR]) in the RSV load of nasopharyngeal swabs in patients three days after treatment with A-60444, compared to patients treated with placebo

Secondary Outcome Measures

Change in viral titre over treatment period
Safety, pharmacokinetics (PK)

Full Information

First Posted
October 4, 2005
Last Updated
February 11, 2010
Sponsor
Arrow Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00232635
Brief Title
A Study of the Safety and Efficacy of A-60444 in Adults With Respiratory Syncytial Virus (RSV) Infection Following HSCT
Official Title
A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Safety and Efficacy of A-60444 in Adults With RSV Infection Following Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Arrow Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objectives Primary Objectives: Pilot Study: A preliminary assessment of the exposure and safety of oral A-60444 in post-stem cell transplant patients with RSV infection. Main Study: To determine the antiviral effect of oral A-60444 versus placebo in post-stem cell transplant patients with RSV infection and to assess the safety of oral A-60444 in post-stem cell transplant patients with RSV infection. Secondary Objectives: To study the pharmacokinetics of A-60444 in the presence of concomitant medications such as immunosuppressants and antifungals, in post-stem cell transplant patients with RSV infection. Sample Size: Six patients will be included in the open, pilot phase of the study and there is an option to include a further 22 patients into the main, placebo-controlled study, depending on the pilot study findings. An independent Data Safety Monitoring Board will assess the findings of the pilot study.
Detailed Description
Clinical will be recorded daily. A-60444 PK will be studied pre-dose and at peak dose on the last day (Day 5) of dosing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
RSV, HSCT, HEMATOPOIETIC STEM CELL TRANSPL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
A-60444
Primary Outcome Measure Information:
Title
Reduction of viral load over time:
Title
2-log reduction (by quantitative real time reverse transcription polymerase chain reaction [rtRT PCR]) in the RSV load of nasopharyngeal swabs in patients three days after treatment with A-60444, compared to patients treated with placebo
Secondary Outcome Measure Information:
Title
Change in viral titre over treatment period
Title
Safety, pharmacokinetics (PK)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with RSV infection who have had a stem cell transplant. Female patients must be of non-childbearing potential or have a negative pregnancy test prior to study start and be deemed not at risk of becoming pregnant. Females of non-childbearing potential are defined as women who have had a hysterectomy, bilateral oophorectomy, tubal ligation, or who have been post-menopausal for at least two years; or are considered to be sterile due to recent chemotherapy. Aged between 18 and 65 years. Patients who have given their written informed consent to participate in the study. Patients who are willing and able to comply with the protocol and study procedures. Exclusion Criteria: Patients who have received an investigational drug within one month preceding the start of dosing. Patients who have a documented history of allergy to benzodiazepines. Patients with significant hepatic impairment (alanine transaminase [ALT] more than 5 x upper level of normal [ULN], total bilirubin more than 3 x ULN). Biochemistry data collected four weeks prior to screening is acceptable. Patients, who in the opinion of their general practitioner or the Investigator, should not participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen MacKinnon
Organizational Affiliation
Royal Free Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stephen MacKinnon
City
London
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study of the Safety and Efficacy of A-60444 in Adults With Respiratory Syncytial Virus (RSV) Infection Following HSCT

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