Status:
COMPLETED
Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM
Lead Sponsor:
University Hospital, Limoges
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Peg interferon and ribavirin currently represent the standard approved association for treating patients infected with hepatitis C virus (HCV) . The adjunction of amantadine is expected to gain about ...
Detailed Description
The study is conducted in naive patients infected with genotype non 2 non 3 administered peginterferon alpha 2-a (40KD) weekly, and ribavirin with dose adjusted on BW (\< 75 kg 1000 mg/day, \>75 kg 12...
Eligibility Criteria
Inclusion
- Male and female patients \>18 years of age and \<65 years of age
- Génotype non2 non3
- Chronic liver disease consistent with chronic hepatitis C infection on a biopsy (obtained within the past 24 months) as judged by a local pathologist (Metavir \>A1and \>F1)
- Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
Exclusion
- Women with ongoing pregnancy or breast feeding
- IFN or ribavirin therapy at any previous time
- Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, anti-HIV Ab
- History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- Serum creatinine level \>1.5 times the upper limit of normal at screening
- History of severe psychiatric disease, especially depression
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00199719
Start Date
June 1 2003
End Date
September 1 2006
Last Update
July 30 2025
Active Locations (2)
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1
Service d'Hépato-gastroentérologie
Angers, France
2
Service d'Hépatogastroentérologie
Limoges, France