Status:
TERMINATED
Switch From Tacrolimus to Cyclosporin in the Treatment of Recurrent Hepatitis C After Liver Transplantation
Lead Sponsor:
Rennes University Hospital
Collaborating Sponsors:
Novartis
Conditions:
Chronic Hepatitis C
Evidence of Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In France, 50% of 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 tran...
Detailed Description
In France, 50% of 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 tran...
Eligibility Criteria
Inclusion
- Adults aged 18 or over,
- Who had been included in the Transpeg 1 study,
- Non-responders after a three month peginterferon alfa-2a / ribavirin bitherapy or with a recurrent disease during the Transpeg 1 maintenance phase, whatever the randomization group (ribavirin or placebo),
- With a positive qualitative PCR at inclusion,
- With a METAVIR histologic score of 1 or more on the last biopsy (done within the 6 months preceding inclusion),
- Treated with tacrolimus for at least 6 months prior to inclusion,
- Having given a written informed consent.
Exclusion
- Treatment with peginterferon or ribavirin within the 6 months preceding inclusion,
- Severe hepatocellular failure or decompensated cirrhosis,
- Acute graft rejection within the two months preceding inclusion, or signs of chronic rejection on the last biopsy, or retransplantation since inclusion in the Transpeg 1 study,
- Treatment with cyclosporin for more than 6 months during the 24 months preceding inclusion,
- Treatment with a mTOR inhibitor or with another investigational immunosuppressive drug,
- Positive serology for HIV or HBV,
- Cancer (or history of other malignancy during the last 5 years) except patients transplanted for hepatocellular carcinoma and basocellular or excised spinocellular carcinoma,
- Serious concomitant disease or acute or chronic disorder, other than the current transplant, treated with steroids,
- Serious cardiac pathology within the last 6 months,
- Women with ongoing pregnancy or breast-feeding,
- Serious chronic renal failure (creatinine clearance \< 30 ml/mn),
- Haemoglobin \< 10 g/dl, platelets \< 50 000/mm3 or neutrophils \< 1000 / mm3,
- Abnormal TSH values,
- Inability to cooperate or to communicate with the investigator,
- Contraindications to ribavirin, peginterferon alfa-2a or cyclosporin.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00375895
Start Date
June 1 2006
End Date
December 1 2009
Last Update
March 2 2012
Active Locations (13)
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1
Service d'Hépatologie - Hôpital Jean Minjoz
Besançon, France, 25030
2
Service d'Hépatogastroentérologie - Hôpital Beaujon
Clichy, France, 92118
3
Service d'Hépatologie et Gastroentérologie - CH Henri Mondor
Créteil, France, 94010
4
Service des Maladies de l'Appareil Digestif - CHRU Claude Huriez
Lille, France, 59037