Status:
COMPLETED
Treatment of Recurrent Hepatitis C After Liver Transplantation
Lead Sponsor:
Rennes University Hospital
Collaborating Sponsors:
Ministry of Health, France
ANRS, Emerging Infectious Diseases
Conditions:
Liver Transplantation
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In France, 50% of the hepatitis C virus carriers develop chronic clinical hepatitis, which may lead to cirrhosis and liver transplantation. Transplant infection by hepatitis C virus is constant after ...
Detailed Description
Several therapeutic patterns have been described for the treatment of hepatitis C post-transplantation recurrence. A combination treatment associating interferon-α and ribavirin has shown some efficac...
Eligibility Criteria
Inclusion
- First liver transplantation or retransplantation in the month after initial transplantation
- Patients aged over 18 years
- Post-hepatitis C cirrhosis
- Equilibrated immunosuppressive treatment
- Positive PCR for hepatitis C virus
- Liver biopsy between 6 months and 5 years after the transplantation with a fibrosis Metavir score at least F1
- Hemoglobin ≥ 10 g/dl
- Platelet count ≥ 50.000/mm3
- Normal TSH value
- Serum creatinine \< 200µmol/l
- Informed written consent
Exclusion
- Chronic rejection
- Acute rejection at inclusion
- Multi-visceral transplantation
- Renal or cardiac failure, severe sepsis
- Uncontrolled diabetes
- Positive serology for hepatitis B or HIV at inclusion
- EBV virus replication at inclusion
- Hepatocellular carcinoma at inclusion
- Cirrhosis with a fibrosis Metavir score F4 at inclusion
- Inclusion in another clinical trial less than one month ago
- Pregnancy
- Contra-indication to ribavirin or interferon
- History of or current psychiatric troubles
- Thyroid disease uncontrolled by treatment
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00151580
Start Date
February 1 2002
End Date
July 1 2006
Last Update
May 21 2012
Active Locations (16)
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1
Service d'Hépatologie - Hôpital Jean Minjoz
Besançon, France, 25030
2
Service de Chirurgie Digestive - Groupe Hospitalier Pellerin-Tripode
Bordeaux, France, 33000
3
Service d'Hépatogastroentérologie - Hôpital Beaujon
Clichy, France, 92110
4
Service d'Hépatologie et Gastroentérologie - Hôpital Henri Mondor
Créteil, France, 94010