Back to resultsA Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Ribavirin in Hemophiliac Patients With Chronic Hepatitis C.
Primary Purpose
Hepatitis C, Chronic
Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
peginterferon alfa-2a [Pegasys]
ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Chronic
Eligibility Criteria
Inclusion Criteria:
- male patients, >=18 years of age;
- hemophilia A;
- chronic hepatitis C;
- compensated liver disease.
Exclusion Criteria:
- therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment <=6 months before start of study drug;
- hepatitis A, hepatitis B or HIV infection;
- chronic liver disease other than chronic hepatitis C.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
SVR
Secondary Outcome Measures
AEs, laboratory parameters.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00475072
Brief Title
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Ribavirin in Hemophiliac Patients With Chronic Hepatitis C.
Official Title
An Open Label Study to Evaluate the Safety and Effect on Sustained Virological Response of PEGASYS Plus Ribavirin in Patients With Hemophilia A and Chronic Hepatitis C
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the efficacy and safety of PEGASYS plus ribavirin in male patients with hemophilia A and chronic hepatitis C. All patients will receive PEGASYS 180 micrograms s.c. weekly plus ribavirin 1000-1200mg p.o. daily (depending on body weight) for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 micrograms sc weekly for 48 weeks
Intervention Type
Drug
Intervention Name(s)
ribavirin
Intervention Description
1000/1200mg po daily for 48 weeks
Primary Outcome Measure Information:
Title
SVR
Time Frame
Week 72
Secondary Outcome Measure Information:
Title
AEs, laboratory parameters.
Time Frame
Throughout study
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male patients, >=18 years of age;
hemophilia A;
chronic hepatitis C;
compensated liver disease.
Exclusion Criteria:
therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment <=6 months before start of study drug;
hepatitis A, hepatitis B or HIV infection;
chronic liver disease other than chronic hepatitis C.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Mexico City
ZIP/Postal Code
02990
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Ribavirin in Hemophiliac Patients With Chronic Hepatitis C.
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