Overview

Study Comparing the Tolerability and Viral Reduction of the Combination of IFN a-2b XL + Ribavirin Versus Peg IFN a-2b + Ribavirin in Patients With Chronic Hepatitis C, Genotype 1 or 4

Status:
Unknown status
Trial end date:
2013-11-01
Target enrollment:
0
Participant gender:
All
Summary
Three-parallel-arm, open-label, international (France and Romania) study, comparing three treatments The purpose of this study is to confirm if IFN alfa-2b XL has a better antiviral activity and tolerability as compared with current marketed reference, while combined with ribavirin, in a 3-month therapy setting.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ANRS, Emerging Infectious Diseases
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborator:
Flamel Technologies
Treatments:
Interferon alpha-2
Interferon-alfa-1b
Interferon-alpha
Ribavirin
Criteria
Inclusion Criteria:

- Patient having voluntarily signed the Informed Consent Form prior to any study
specific procedure being performed

- Male or female HCV genotype 1 or 4 infected patients (positive serum HCV RNA), aged
between 18 and 65 years inclusive, with a body mass within the range over or equal of
45Kg and below or equal to 100 Kg

- Patient being either naïve to therapy, either non-responder to previous standard
Peg-interferon α + ribavirin therapy,

- With no absolute contra-indication to interferon α or ribavirin

- Female patients must be non-lactating and of non-childbearing potential, or have a
negative pregnancy test results to enter the study

- No evidence of acute or advanced liver disease, uncontrolled diabetes, cardiovascular,
immunological, or thyroid disease, and no recently diagnosed malignancy

- Vital signs within normal ranges, or if outside the normal ranges, not deemed
clinically significant in the opinion of the Investigator. An ECG with no clinically
significant abnormalities

Exclusion Criteria:

- History of solid organ transplantation

- Severe systemic infection, uncontrolled diabetes, cancers, associated liver disease

- General anesthesia or recent blood transfusion