Phase 4
Completed N=39
Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation
Source: ClinicalTrials.gov NCT00821587 ↗Enrolled (actual)
39
Serious AEs
2.6%
Results posted
Dec 2011
Primary outcomePrimary: Number of Participants With Less Than 100 Hepatitis C Virus RNA Copies/mL — 7; 7 Participants — p=<0.05
Summary
The purpose of this study is to evaluate the effect of cyclosporine, an anti-rejection drug, on the clearance of the hepatitis C virus in liver transplant subjects being treated with peg-interferon and ribavirin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Less Than 100 Hepatitis C Virus RNA Copies/mL |
7; 7 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Males and females age 18 years and older
- HCV RNA positive by PCR after liver transplantation
- Elevated ALT at any time point after liver transplantation
- Protocol liver biopsy (standard of care) consistent with Stage greater than or equal to 2 of Ishak fibrosis score after liver transplantation
- Able to provide written informed consent
- Willing to practice acceptable birth control during the study period.
Exclusion Criteria
- Decompensated Cirrhosis
- hemoglobin 2.0 mg/dl
- Severe non-hepatic illnesses
Data sourced from ClinicalTrials.gov (NCT00821587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.