Status:
TERMINATED
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
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
Schering-Plough
Conditions:
Hepatitis C, Chronic
Eligibility:
18-65 years
Phase:
PHASE3
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 com...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
End Date :
May 1 2003
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT00122629
Start Date
October 1 2000
End Date
May 1 2003
Last Update
July 29 2005
Active Locations (1)
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1
Service d'Hépato-Gastroentérologie Hopital Hotel Dieu
Lyon, France, 69288