Chronic Hepatitis C
Conditions
Keywords
hepatitis C, viral kinetics, antiviral response, Genotype 1 or 4
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.
Interventions
DRUGIFN alfa-2b XL 27 MUI + Ribavirin
IFN alfa-2b XL 27 MUI administered once a week for 12 weeks by subcutaneous injections, in combination with weight dosed ribavirin daily administered orally in two divided doses
DRUGIFN alfa-2b XL 36 MUI + Ribavirin
IFN alfa-2b XL 36 MUI administered once a week for 12 weeks by subcutaneous injections in combination with weight dosed ribavirin daily administered orally in two divided doses
DRUGIFN peg alfa-2b 1.5 µg/kg + Ribavirin
IFN peg alfa-2b 1.5 µg/kg administered once a week for 12 weeks by subcutaneous injections in combination with weight dosed ribavirin daily administered orally in two divided doses
Sponsors
ANRS, Emerging Infectious Diseases
Flamel Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Week 4 and Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with early virologic response (EVR) (reduction of at least 2 log viral load) at the end of week 12 | Week 4 and Week 12 |
| Percentage of patients with complete early virologic response (EVR) (viral load <15 IU) at the end of the week 12 | Week 4 and Week 12 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORChristian TREPO, MD
Hôpital de la Croix Rousse, Service d'Hépato-Gastro-Entérologie, 69004 Lyon - FRANCE
Outcome results
None listed