A Phase 3 interventional study of ciclosporin in Chronic Hepatitis C and Evidence of Liver Transplantation, sponsored by Rennes University Hospital. Terminated at 13 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-02.
Sponsored by Rennes University Hospital · Phase 3, Interventional, and Treatment
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 transplantation and recurrence causes chronic liver disease in 50 to 80% of cases. The aim of this study is to assess the efficacy of cyclosporin on C virological response. Patients included in the Transpeg 1 study and non-responder or with a recurrent disease will be switched from their tacrolimus therapy to cyclosporin, in association with a 1 year peginterferon alfa-2a / ribavirin bitherapy. Efficacy will be assessed by the percentage of patients with a negative qualitative PCR after 19 months of cyclosporin treatment.
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 transplantation. A main factor determining the severity of recurrent hepatitis C after transplantation may be immunosuppression. Thus optimization of immunosuppressive regimens might be a key aspect to improve the prognosis of chronic hepatitis C in transplanted patients. The two most frequently used immunosuppressive drugs are cyclosporin and tacrolimus. However, it has been shown that virus replication could be inhibited by cyclosporin, through the blockade of cyclophilins, decreasing hepatitis C viral load and improving liver function. These effects were not found with tacrolimus.
The aim of our study is to assess the efficacy on C virological response of the switch from tacrolimus to cyclosporin associated with a peginterferon alfa-2a / ribavirin bitherapy, in non-responder or with a recurrent VHC+ disease liver transplanted patients.
Patients will receive a 19 month cyclosporin treatment, associated during 12 months with a peginterferon alfa-2a / ribavirin bitherapy. Efficacy will be assessed by the percentage of patients with a negative qualitative PCR after 19 months of cyclosporin treatment.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 11 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Drug: ciclosporin
ciclosporin administered orally twice a day, at the initial dosing of 2.5 mg/kg/d, adjusted to obtain a C2 concentration of 600 ng/ml associated with the usual ribavirin and PEGinterferon bitherapy.
Also known as: CsA, Cyclosporin
Prolonged virological response
Percentage of patients with a negative qualitative PCR, 19 months after the initiation of cyclosporin treatment.
Time frame: 19 months
Virological response 4, 7 and 13 months after the initiation of cyclosporin treatment
Percentage of patient with negative or decreased quantitative PCR
Time frame: 4, 7 and 13 months
Histological response: METAVIR score at 19 months
Time frame: 19 months
Biological response: liver function at 4, 7, 13 and 19 months
Transaminases, gammaGT, alcalin phosphatase, total bilirubin.
Time frame: 4, 7, 13 and 19 months
Incidence of acute or chronic graft rejection at 19 months
Time frame: 19 months
Incidence of death, graft loss and retransplantation at 13 and 19 months
Time frame: 13 and 19 months
Renal function at 4, 7, 13 and 19 months
Creatinin clearance
Time frame: 4, 7, 13 and 19 months
Incidence of treatment discontinuation at 4, 7, 13 and 19 months
Time frame: 4, 7, 13 and 19 months
Incidence of adverse events (cancers in particular).
Time frame: 19 months
This study is terminated, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Rennes University Hospital