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Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C

Information source: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C

Intervention: Telaprevir (Drug); Ribavirin (Drug); Pegylated Interferon Alfa-2a (Biological)

Phase: Phase 4

Status: Terminated

Sponsored by: Vertex Pharmaceuticals Incorporated

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Vertex Pharmaceuticals Incorporated

Summary

The purpose of this study is to evaluate the efficacy and safety of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in treatment-experienced Black/African American and non-Black/African American participants with Genotype 1 Chronic Hepatitis C (CHC), who have not achieved a sustained viral response with a prior course of interferon-based therapy.

Clinical Details

Official title: An Open-Label, Phase 4 Study of Telaprevir, Peginterferon Alfa-2a (PegasysŪ), and Ribavirin (CopegusŪ) in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C Who Have Not Achieved a Sustained Viral Response With a Prior Course of Interferon-Based Therapy

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)

Secondary outcome:

Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)

Percentage of Participants With Extended Rapid Viral Response (eRVR)

Percentage of Participants With Relapse

Percentage of Participants With Virologic Breakthrough

Percentage of Participants With On Treatment Virologic Failure

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region

Detailed description: This is a single-arm, open-label, multicenter study of treatment-experienced participants with Genotype 1 CHC, who self-identified as Black/African American (Group A) or who did not self-identify as Black/African American (Group B). Participants did not achieve a sustained virologic response 24 weeks after at least 1 prior course of Peg-IFN-alfa-2a/RBV therapy of standard duration, and have 1 of the following viral responses:

- Prior relapse: Participant had a documented undetectable hepatitis C virus ribonucleic

acid (HCV RNA) level at the planned end of treatment of at least 42 weeks duration (HCV RNA evaluated anytime between 3 weeks before and 6 weeks after the last dose of Peg IFN-alfa-2a or RBV).

- Prior null response: Participant had a <2-log10 decrease in HCV RNA at 12 weeks, during

prior Peg IFN-alfa-2a/RBV treatment, but never achieved undetectable HCV RNA while on treatment.

- Prior partial response: Participant had a >=2-log10 decrease in HCV RNA at 12 weeks,

during prior Peg IFN-alfa-2a/RBV treatment, but never achieved undetectable HCV RNA while on treatment.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participants self-identify as Black/African American (Group A) or did not

self-identify as Black/African American (Group B)

- Participants have Genotype 1 CHC and laboratory evidence of hepatitis C virus (HCV)

infection for at least 6 months

- Participants did not achieve sustained viral response 24 weeks after last dose of

study drug (SVR24), after at least 1 prior course of Peg-IFN-alfa-2a/RBV therapy of standard duration Exclusion Criteria:

- Participants have received previous treatment with telaprevir or any other protease

inhibitor(s) for CHC

- Participants who have evidence of hepatic decompensation

- Participants have diagnosed or suspected hepatocellular carcinoma

- Participants have any other cause of significant liver disease in addition to HCV

- Participants are currently abusing illicit drugs or alcohol, or have history of

illicit substance or alcohol abuse within 2 years before the screening visit

- Participants who participated in any investigational drug study within 90 days before

dosing

Locations and Contacts

Alabama, Birmingham, Alabama, United States

California, San Francisco, California, United States

Connecticut, New Haven, Connecticut, United States

Washington, DC, Washington, District of Columbia, United States

Florida, Miami, Florida, United States

Florida, Orlando, Florida, United States

Florida, Tampa, Florida, United States

Florida, West Palm Beach, Florida, United States

Georgia, Atlanta, Georgia, United States

Illinois, Chicago, Illinois, United States

Louisiana, Baton Rouge, Louisiana, United States

Louisiana, New Orleans, Louisiana, United States

Louisiana, Shreveport, Louisiana, United States

Maryland, Baltimore, Maryland, United States

Massachusetts, Boston, Massachusetts, United States

Michigan, Detroit, Michigan, United States

New Jersey, Vineland, New Jersey, United States

New York, Bronx, New York, United States

New York, New York, New York, United States

North Carolina, Charlotte, North Carolina, United States

North Carolina, Durham, North Carolina, United States

Pennsylvania, Philadelphia, Pennsylvania, United States

Texas, Dallas, Texas, United States

Texas, Houston, Texas, United States

Texas, San Antoinio, Texas, United States

Virginia, Norfolk, Virginia, United States

Washington, Seattle, Washington, United States

Additional Information

Starting date: January 2012
Last updated: July 13, 2015

Page last updated: August 23, 2015

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