Clinical trial 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
Official title: Multicentre, Randomised, Open-label Study Comparing the Tolerability and Viral Reduction of the Combination of IFN Alpha-2b XL + Ribavirin Versus Peg IFN Alpha-2b + Ribavirin in Patients With Chronic Hepatitis C, Genotype 1 or 4.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: hepatitis C
viral kinetics
antiviral response
Genotype 1 or 4
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Flamel Technologies
First posted: 2009-11-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Interferon alfa-2b XL (IFN alfa-2b XL) is a novel sustained release interferon α-2b drug product that is being developed by FLAMEL TECHNOLOGIES using its Medusa® technology, aiming at reducing the toxicity and enhancing the biological response. In the present study, patients will be randomly assigned to either IFN alfa-2b XL 27 MUI, IFN alfa-2b XL 36 MUI, or IFN peg alfa-2b 1.5 µg/kg, all administered once a week for 12 weeks by subcutaneous injections, in combination with weight dosed ribavirin daily administered orally in two divided doses. Doses will be adapted according to the dose modification guidelines for combination therapy labelled in the ribavirin prescribing information.

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

Primary outcomes:
measure: Viral load decrease at Week 4 and Week 12 of treatment with IFN alfa-2b XL 27 MIU, IFN alfa-2b XL 36 MIU and the marketed reference product (PEG IFN alfa-2b 1.5μg/kg) in combination with ribavirin
timeFrame: Week 4 and Week 12
Secondary outcomes:
measure: Percentage of patients with early virologic response (EVR) (reduction of at least 2 log viral load) at the end of week 12
timeFrame: Week 4 and Week 12
measure: Percentage of patients with complete early virologic response (EVR) (viral load <15 IU) at the end of the week 12
timeFrame: Week 4 and Week 12
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
Study officials:
affiliation: Hôpital de la Croix Rousse, Service d'Hépato-Gastro-Entérologie, 69004 Lyon - FRANCE
name: Christian TREPO, MD
role: PRINCIPAL_INVESTIGATOR
References: