Status:
COMPLETED
A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Collaborating Sponsors:
Tibotec Pharmaceutical Limited
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
1095 Patients enrolled
Trial Details
Trial ID
NCT00627926
Start Date
March 1 2008
End Date
May 1 2010
Last Update
August 8 2014
Active Locations (116)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham, Alabama, United States, 35209
2
Birmingham, Alabama, United States, 35294
3
Phoenix, Arizona, United States, 85054
4
Fresno, California, United States, 93721