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
1 other identifier
interventional
405
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2000
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 20, 2005
CompletedFirst Posted
Study publicly available on registry
July 22, 2005
CompletedJuly 29, 2005
July 1, 2005
July 20, 2005
July 28, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sustained virological response, defined as an undetectable HCV-RNA 24 weeks after treatment discontinuation at week 72
Secondary Outcomes (4)
Biochemical response at week 72 defined as ALT normalization
Histological benefit
Tolerance
Virological and biochemical responses during therapy at weeks 12, 24 and 48
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service d'Hépato-Gastroentérologie Hopital Hotel Dieu
Lyon, 69288, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Trepo, MD
Hépato-Gastroentérologie Hopital Hôtel-Dieu LYON
- STUDY CHAIR
P. ADELEINE, MD
Laboratoire d'Informatique Médicale Lyon
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
July 20, 2005
First Posted
July 22, 2005
Study Start
October 1, 2000
Study Completion
May 1, 2003
Last Updated
July 29, 2005
Record last verified: 2005-07