Trials Sponsors Conditions Drugs Pricing

Conditions

Hepatitis C, Chronic Liver Fibrosis

Keywords

Maintenance therapyNon-responder patientsRibavirin/peginterferon combination therapyHepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

Rate of patients with at least a one point improvement in Metavir fibrosis score between the inclusion and the end-of-study liver biopsies.
Screen visit and M36

Secondary Outcomes (9)

Distribution of the Metavir scoring on the end-of-study biopsy
M36
Distribution of the Chevallier fibrosis score
Screen visit and M36
Evolution of the area of fibrosis between the inclusion and the end-of -study biopsies
Screen visit and M36
Fibrosis serum markers
Screen, day0, M6, M12, M24, M36
Liver elasticity before and after treatment
Screen,M12, M24, M36
+4 more secondary outcomes

Study Arms (2)

Randomised PegIFN alfa 2b + ribavirin (RBV) arm

EXPERIMENTAL

Combination of ribavirin capsules 200 mg, weight-based daily dose ( \<75 kg : 1000 mg ; ≥ 75 kg : 1200 mg), and low-dose PegIFN alfa 2b by subcutaneous injection 0.5 μg / kg / week, from day 0 to M36

Biological: Peginterferon alfa-2bDrug: Ribavirin

Randomised PegIFN alfa 2b + ribavirin-placebo arm

PLACEBO COMPARATOR

Combination of ribavirin-placebo capsules 200 mg, weight-based daily dose ( \<75 kg : 1000 mg ; ≥ 75 kg : 1200 mg), and low-dose PegIFN alfa 2b by subcutaneous injection 0.5 μg / kg / week, from day 0 to M36

Biological: Peginterferon alfa-2bDrug: Ribavirin-Placebo

Interventions

Peginterferon alfa-2bBiological

PegIFN alfa 2b in addition to ribavirin or ribavirin-placebo, from day 0 to M36

Randomised PegIFN alfa 2b + ribavirin (RBV) armRandomised PegIFN alfa 2b + ribavirin-placebo arm

RibavirinDrug

Ribavirin in addition to PegIFN alfa 2b, from day 0 to M36

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adults over 18
With a hepatitis C virus infection (HCV RNA and anti-HCV antibodies in serum)

Sponsors & Collaborators

ANRS, Emerging Infectious Diseases
Governmentlead
Rennes University Hospital
Othercollaborator
Merck Sharp & Dohme LLC

Study Sites (45)

CHU Brugmann

Brussels, 1020, Belgium

Hôpital Bracops

Brussels, 1070, Belgium

Hôpital Erasme

Brussels, 1070, Belgium

Hôpital de Jolimont

La Louvière, 7100, Belgium

CHU Sart Tilman

Liège, 4000, Belgium

Service d'Hépatogastroentérologie et d'endoscopie digestive - CH du Pays d'Aix

Aix-en-Provence, 13616, France

Hôpital Nord

Amiens, 80054, France

MeSH Terms

Conditions

Hepatitis C, ChronicLiver Cirrhosis

Interventions

peginterferon alfa-2bRibavirin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitis

Study Officials

Dominique Guyader, MD, PhD
Rennes University Hospital
PRINCIPAL INVESTIGATOR
Eric Bellissant, MD, PhD
Rennes University Hospital
STUDY CHAIR

Enrollment

372 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER GOV
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 9, 2006

First Posted

May 10, 2006

Study Start

May 2006

Date type not reported

This date has not been verified as actual or estimated.

Interest of Ribavirin in the Maintenance Treatment of Liver Fibrosis Using Low Dose Pegylated Interferon alpha2b in Patients With Chronic Hepatitis C Non Responders to Previous Antiviral Therapy.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

Randomised PegIFN alfa 2b + ribavirin (RBV) arm

Randomised PegIFN alfa 2b + ribavirin-placebo arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (45)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

Randomised PegIFN alfa 2b + ribavirin (RBV) arm

Randomised PegIFN alfa 2b + ribavirin-placebo arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (45)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations