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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

Information source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis C

Intervention: IFN alfa-2b XL 27 MUI + Ribavirin (Drug); IFN alfa-2b XL 36 MUI + Ribavirin (Drug); IFN peg alfa-2b 1.5 µg/kg + Ribavirin (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Official(s) and/or principal investigator(s):
Christian TREPO, MD, Principal Investigator, Affiliation: Hôpital de la Croix Rousse, Service d'Hépato-Gastro-Entérologie, 69004 Lyon - FRANCE

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

Percentage of patients with early virologic response (EVR) (reduction of at least 2 log viral load) at the end of week 12

Percentage of patients with complete early virologic response (EVR) (viral load <15 IU) at the end of the week 12

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Hôpital de la Croix Rousse, Lyon 69004, France
Additional Information

French National Agency for Research on AIDS and Viral Hepatitis website

Starting date: March 2010
Last updated: September 19, 2013

Page last updated: August 23, 2015

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