Status:
COMPLETED
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.
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Rennes University Hospital
Conditions:
Hepatitis C, Chronic
Liver Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Patients with chronic hepatitis C who did not respond to previous antiviral treatment develop liver fibrosis leading to cirrhosis. Maintenance low dose pegylated interferon therapy of fibrosis is curr...
Detailed Description
Up to 45% of patients with chronic hepatitis C do not respond to pegylated interferon/ribavirin combination therapy. These patients are prone to develop liver fibrosis leading to cirrhosis and its com...
Eligibility Criteria
Inclusion
- Adults over 18
- With a hepatitis C virus infection (HCV RNA and anti-HCV antibodies in serum)
- Not responders to a previous antiviral treatment using the interferon plus ribavirin combination
- With a wash-out of treatment for at least 6 months
- With an active chronic hepatitis C and a Metavir fibrosis score ≥ 2
- Serum ALT levels \> upper limit of the laboratory on two occasions within 6 months before inclusion
- Accepting to undergo a liver biopsy at the end of the study
- Negative pregnancy test for women
- With a social security cover
- Written informed consent
Exclusion
- History of hepatic complications
- History of transplantation
- History of severe seizures
- History of severe psychiatric disorders
- Drug addiction within the last 12 months
- Associated condition susceptible to be responsible for liver fibrosis
- Hepatocellular carcinoma
- Cardiovascular disease unstable under treatment
- Uncontrolled diabetes
- Retinopathy
- Thyroid disease unstable under treatment
- Epilepsy and/or central nervous system functional disorders
- Autoimmune disease
- Regular alcohol consumption
- Pregnancy, breast-feeding or absence of contraception
- Haemoglobin \<12 g/dl
- platelets \<50000/mm3
- Neutrophils \< 1200/ mm3
- Severe hepatocellular failure (prothrombin index lower than 60%)
- Renal failure (creatinine clearance lower than 50 mL/Mn)
- Associated immunosuppressive drugs, corticosteroids, antiviral drugs (other than study ones)
- Treatment with drugs likely to have an effect on fibrosis
- Anticonvulsants
- Inability to tolerate interferon
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT00323804
Start Date
May 1 2006
End Date
March 1 2013
Last Update
September 4 2014
Active Locations (45)
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1
CHU Brugmann
Brussels, Belgium, 1020
2
Hôpital Bracops
Brussels, Belgium, 1070
3
Hôpital Erasme
Brussels, Belgium, 1070
4
Hôpital de Jolimont
La Louvière, Belgium, 7100