Triple Therapy With Peg-Interferon Alfa-2b/Ribavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2b/Ribavirin for Previous Hepatitis C Virus (HCV) Non Responders

This study has been terminated.
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00122629
First received: July 20, 2005
Last updated: July 28, 2005
Last verified: July 2005
  Purpose

Triple antiviral therapy with peg-interferon-alfa/ribavirin+amantadine was suggested to increase sustained virological response (SVR) rates in HCV non-responders to a standard interferon/ribavirin combination.

Patients with hepatitis C virus infection were eligible if they had failed to respond to a single previous 24 week cycle of interferon/ribavirin combination therapy. Non-response was defined as persistent HCV RNA in the serum during the last month of treatment.

This study tested the efficacy and safety of pegylated interferon alfa-2b with ribavirin and amantadine or a placebo for 48 weeks.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: peg-interferon alfa-2b
Drug: ribavirin
Drug: amantadine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Triple Therapy With Peg-Interferon Alfa-2b/Ribavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2b/Ribavirin for Previous HCV Non Responders ANRSHC03 BITRI

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • Sustained virological response, defined as an undetectable HCV-RNA 24 weeks after treatment discontinuation at week 72

Secondary Outcome Measures:
  • Biochemical response at week 72 defined as ALT normalization
  • Histological benefit
  • Tolerance
  • Virological and biochemical responses during therapy at weeks 12, 24 and 48

Estimated Enrollment: 405
Study Start Date: October 2000
Estimated Study Completion Date: May 2003
Detailed Description:

Triple antiviral therapy with peg-interferon-alfa/ribavirin + amantadine was suggested to increase sustained virological response (SVR) rates in HCV non-responders to a standard interferon/ribavirin combination.

The aim of this study is to determine if the addition of amantadine to PEG-IFN/ribavirin enhances SVR.

This study is a double blind, comparative, prospective multicenter, randomized study. Patients are recruited from 23 hepatology centers in France. The protocol was approved by the French ethical committee and all patients provided written informed consent. Eligible subjects are randomly assigned to the two treatment groups in equal proportions. The randomization process is generated by the Department of Biostatistics, Hospices Civils de Lyon, Lyon, France.

Main inclusion criteria are: elevated ALT, detectable HCV RNA, Metavir score over or equal to A1F1 and below or equal to F3. Patients received PEG-IFN 1.5µg/kg/week, ribavirin 800-1200mg/day and amantadine 200mg/day or placebo during 48 weeks.

The primary endpoint is a sustained virological response, defined as an undetectable HCV-RNA 24 weeks after treatment discontinuation (week 72). Secondary endpoints are the biochemical response at week 72 defined as ALT normalization; histological benefit; tolerance; and virological and biochemical responses during therapy at weeks 12, 24 and 48.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive anti-HCV antibody test
  • Patients who did not respond to treatment with standard interferon + ribavirin (HCV RNA+ by PCR in the last month of treatment)
  • Compensated liver disease
  • Neutrophil count over or equal to1000/mm3
  • Platelet count over or equal to 100 giga/L
  • Haemoglobin over or equal to 10g/dL
  • Patients had to have undergone a post-treatment liver biopsy within a year, showing a METAVIR histological score over or equal to A1F1, without cirrhosis (fibrosis score below F4)
  • ALT over N and HCV RNA+ at screening

Exclusion Criteria:

  • Co-infection with hepatitis B or human immunodeficiency virus
  • Any other cause of liver disease
  • Active drug abuse, active alcohol consumption above 40g/day
  • Organ grafts
  • Presence of hepatocellular carcinoma
  • Cardiovascular, metabolic, renal, haematological, neurological or psychiatric disease
  • Patients with previous amantadine use
  • Systemic immunosuppressive or antiviral treatment during the last 24 weeks and those with a history of interferon and/or ribavirin intolerance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122629

Locations
France
Service d’Hépato-Gastroentérologie Hopital Hotel Dieu
Lyon Cedex, France, 69288
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Schering-Plough
Investigators
Principal Investigator: Christian Trepo, MD Hépato-Gastroentérologie Hopital Hôtel-Dieu LYON
Study Chair: P. ADELEINE, MD Laboratoire d’Informatique Médicale Lyon
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00122629     History of Changes
Other Study ID Numbers: ANRSHC03 BITRI
Study First Received: July 20, 2005
Last Updated: July 28, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
Hepatitis C, Chronic
peginterferon alfa-2b
ribavirin
Amantadine

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferons
Ribavirin
Interferon-alpha
Amantadine
Peginterferon alfa-2b
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014