Status:
COMPLETED
A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Collaborating Sponsors:
Tibotec Pharmaceutical Limited
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have ...
Eligibility Criteria
Inclusion
- 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 HCV 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT00758043
Start Date
October 1 2008
End Date
July 1 2010
Last Update
March 26 2021
Active Locations (82)
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Birmingham, Alabama, United States, 35209
2
Birmingham, Alabama, United States, 35294
3
Phoenix, Arizona, United States, 85054
4
Fresno, California, United States, 93721