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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01592006
First received: April 27, 2012
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Hepatitis C
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Drug: telaprevir

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study on the Efficicay and Safety of Pegylated Interferon, Ribavirin and Telaprevir in Recurrent Hepatitis C Virus (HCV) Infection in Orthotopic Liver Transplant (OLT) Recipients.

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • evaluate the efficacy of triple antiviral therapy [ Time Frame: 3 years from start of study ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • safety of triple antiviral therapy in HCV infected OLT recipients [ Time Frame: 6 years from the start of the study ] [ Designated as safety issue: Yes ]

    To evaluate the safety of triple antiviral therapy, consisting of pegylated interferon alfa-2a (Pegasys®), ribavirin, and telaprevir therapy in liver transplant recipients with hepatitis C

    To evaluate the pharmacokinetic effects of continuous use of telaprevir on serum cyclosporine or tacrolimus concentrations in this population

    Tolerability and Safety will be measured and reported by serious adverse events.



Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HCV, LT, Pegasys, ribavirin, telaprevir
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
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.
Drug: Ribavirin
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.
Drug: telaprevir
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592006

Contacts
Contact: Helen Te (773) 702-2395 hte@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Helen Te, MD    773-702-2395    hte@medicine.bsd.uchicago.edu   
Principal Investigator: Helen Te, MD         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Helen Te, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01592006     History of Changes
Other Study ID Numbers: 12-0156
Study First Received: April 27, 2012
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
hepatitis C virus
liver transplant recipient

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Peginterferon alfa-2a
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014