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

NCT01592006 | Terminated Phase 4 Results

• 1 other identifier: 12-0156
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis C

Keywords

hepatitis C virus; liver transplant recipient

Outcome Measures

Primary Outcomes (1)

• The Efficacy of Triple Antiviral Therapy

  To evaluate the efficacy of triple antiviral therapy, consisting of pegylated interferon alfa-2a (Pegasys®), ribavirin, and telaprevir therapy in liver transplant recipients with hepatitis C. This will be measured and reported by sustained virologic response (defined as undetectable HCV RNA in the blood 24 weeks after completing therapy \[SVR24\])

  3 years from start of study

Secondary Outcomes (1)

• Safety of Triple Antiviral Therapy in HCV Infected OLT Recipients

  6 years from the start of the study

Study Arms (1)

HCV, LT, Pegasys, ribavirin, telaprevir

EXPERIMENTAL

Patients are being asked to be part of this arm because they are orthotopic liver transplant recipients (OLT) and have the Hepatitis C Virus (HCV). They will be given the study drugs Pegasys, ribavirin and telaprevir

Drug: Peginterferon alfa-2a; Drug: Ribavirin; Drug: telaprevir

Interventions

Peginterferon alfa-2a DRUG

Patients will be treated with pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week for 12 weeks, followed by pegylated interferon alfa-2a (Pegasys®) and ribavirin for another 36 weeks. Patients will be assessed at periodic intervals for safety and adverse effects. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.

HCV, LT, Pegasys, ribavirin, telaprevir

Ribavirin DRUG

Patients will be given ribavirin 600-1200 mg PO per day for 12 weeks, followed by pegylated interferon alfa-2a (Pegasys®) and ribavirin for another 36 weeks. Patients will be assessed at periodic intervals for safety and adverse effects. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.

HCV, LT, Pegasys, ribavirin, telaprevir

telaprevir DRUG

Patients will be given telaprevir 750 mg tid (Incivek®) for 12 weeks, followed by pegylated interferon alfa-2a (Pegasys®) and ribavirin for another 36 weeks. Patients will be assessed at periodic intervals for safety and adverse effects. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.

HCV, LT, Pegasys, ribavirin, telaprevir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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®).

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon alfa-2a; Ribavirin; telaprevir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Dr. Helen S. Te
• Organization: University of Chicago Medical Center

hte@medicine.bsd.uchicago.edu

773-702-2395

Study Officials

• Helen Te, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 4, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 15, 2016
• Results First Posted: January 12, 2015

Record last verified: 2016-05

Locations

US (1)