VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C

Completed · Phase 2

Conditions studied: Chronic Hepatitis C Virus

In brief

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.

Key facts

Study ID

NCT01581138

Run by

Vertex Pharmaceuticals Incorporated

People needed

64

Starts

2012-07-01

Expected to finish

2013-12-01

Last updated by the study team

2014-07-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Anaheim, California, United States
• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — Englewood, Colorado, United States
• Study site — Orlando, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — Baltimore, Maryland, United States
• Study site — New York, New York, United States
• Study site — Asheville, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Germantown, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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