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Completed
NCT01010646
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
Conditions: Chronic Hepatitis C
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 84
Sponsor: ANRS, Emerging Infectious Diseases
Location: Hôpital de la Croix Rousse Lyon
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT01010646). StuddyBuddy aggregates publicly available trial information.