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A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)

A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C

NCT00627926•Vertex Pharmaceuticals Incorporated

View on ClinicalTrials.gov

Summary

A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
•Male and female subjects, 18 to 70 years of age, inclusive
•Genotype 1, chronic hepatitis C with detectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
•Screening laboratory values, tests, and physical exam within acceptable ranges
•Able and willing to follow contraception requirements
•Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions

Exclusion Criteria

•Subject has any contraindications to Pegasys® or Copegus® therapy
•Evidence of hepatic decompensation in cirrhotic subjects
•History of organ transplant
•History of, or any current medical condition which could impact the safety of the subject in participation in the study

Locations (116)

Birmingham, Alabama, United States

Phoenix, Arizona, United States

Fresno, California, United States

La Jolla, California, United States

Long Beach, California, United States

Los Angeles, California, United States

San Diego, California, United States

Key Dates

Start Date

March 1, 2008

Primary Completion Date

May 1, 2010

Completion Date

May 1, 2010

Last Updated

August 8, 2014

Enrollment

1,095

ACTUAL participants

Conditions

Hepatitis C

Interventions

Pegylated Interferon Alfa 2a

BIOLOGICAL

Telaprevir

DRUG

Ribavirin

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 8, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)

Inclusion Criteria

Exclusion Criteria

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