VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C
Status and phase
Completed
Phase 2
Conditions
Chronic Hepatitis C Virus
Treatments
Drug: VX-222
Drug: telaprevir
Drug: ribavirin
Details and patient eligibility
About
The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.
Enrollment
64 patients
Sex
All
Ages
18 to 70 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Subjects must have genotype 1 chronic hepatitis C (CHC) and laboratory evidence of HCV infection for at least 6 months before the Screening Visit
- Subjects will be treatment naïve
- Subjects must have documentation of the presence or absence of cirrhosis
Exclusion criteria
- History or other clinical evidence of significant or unstable cardiac disease
- Evidence of hepatic decompensation
- Diagnosed or suspected hepatocellular carcinoma
- Any other cause of significant liver disease in addition to hepatitis C, which may include but is not limited to malignancy with hepatic involvement, hepatitis B, drug-or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
- History of organ transplant, with the exception of corneal transplants and skin grafts
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
64 participants in 2 patient groups
12 week treatment
Experimental group
Treatment:
Drug: ribavirin
Drug: VX-222
Drug: telaprevir
16 week treatment
Experimental group
Treatment:
Drug: ribavirin
Drug: VX-222
Drug: telaprevir
Trial contacts and locations
18
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Data sourced from clinicaltrials.gov
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