Pegylated Interferon, Ribavirin, Telaprevir in Hepatitis C Virus Infection in Orthotopic Liver Transplant Recipients

• Status: Terminated
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients are being asked to be part of this study because they are a liver transplant recipient and have the Hepatitis C Virus (HCV). Current routine treatment for HCV for liver transplant patients includes taking two medications called pegylated interferon alfa-2a (Pegasys®) and ribavirin. Patients Pegasys and ribavirin are FDA approved for the treatment of HCV.

This study will evaluate the safety and efficacy of adding a third drug called telaprevir for the experimental treatment of HCV in liver transplant patients. The combination of Pegasys, ribavirin and telaprevir is currently FDA approved for the treatment of HCV, but is specifically not FDA approved for HCV patients who have had a liver transplant. This is because more information is needed about possible drug interactions between telaprevir and cyclosporine, or telaprevir and tacrolimus-based immunosuppressive drugs, which are typically part of routine care for transplant patients.

Studies have shown that the addition of telaprevir greatly increases the efficacy of Pegasys and ribavirin for the treatment of HCV. However, these studies did not include adequate information on transplant patients due to the potential drug interactions.

The investigators hope to gather more information about the safety and efficacy of telaprevir given in combination with Pegasys and ribavirin in the liver transplant patients who have HCV that is not well controlled with Pegasys and ribavirin alone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Male or female patients > 18 years of age.

• Detectable plasma HCV-RNA by qualitative PCR assay.

• HCV genotype 1 infection,

• Documented recurrent hepatitis C by liver biopsy within the past year.

• On cyclosporine or tacrolimus-based immunosuppression

• Negative urine pregnancy test before initiating the treatment for women of childbearing potential.

• Willingness of the patient and all potentially childbearing partners to use a reliable form of effective contraception during the study, unless the patient or partner is surgically sterile or post-menopausal.

• Willingness to undergo provide informed consent and comply with study requirements.

Exclusion Criteria:

• Genotype non-1 HCV infection.

• Women who are pregnant or breast-feeding.

• Male partners of women who are pregnant.

• Evidence of co-infection with HIV or hepatitis B.

• History of severe psychiatric disease.

• History of immunologically mediated disease (e.g., inflammatory bowel disease, lupus erythematosus, rheumatoid arthritis, etc.)

• History of clinically significant pulmonary disease.

• History of severe cardiac disease.

• History of malignancy where risk of recurrence is >20% within 2 years.

• History of uncontrolled seizure disorder.

• History of poorly controlled thyroid disease.

• History of poorly controlled diabetes mellitus.

• History of severe retinopathy.

• Active gout.

• History or evidence of severe medical illness that, in the opinion of the investigator, makes the patient unsuitable for pegylated interferon alfa-2a treatment (Pegasys®).

• Inability or unwillingness to abstain from alcohol throughout the entire study period.