A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

Stopped early · Phase 2

Conditions studied: Chronic Hepatitis C Virus Infection

In brief

The purpose of this study is to assess the safety and efficacy of combination treatment with VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and/or ribavirin. The subjects enrolled in this study are chronically infected with hepatitis C virus (HCV) genotype 1 and will not have previously received treatment for their HCV infection. This study will include an Investigational Phase and Extension Phase. These phases will contain a Treatment Period and a Follow-up Period. All subjects will be enrolled in the Investigational Phase of this study. Subjects who fail treatment during the Investigational Phase will have the option to enter the Extension Phase at which point they will be eligible to receive peginterferon alfa-2a and ribavirin for a total of 48 weeks. Based on an evaluation of on-treatment safety, pharmacokinetic and antiviral data from patients in each arm of the trial, Vertex may elect to enroll up to two additional treatment arms (Treatment Arm E and Treatment Arm F) that will evaluate telaprevir/VX-222-based combination therapy. The components of the treatment regimens of these arms will be selected based on clinical data that emerges from the four initially-studied regimens. If enacted, up to 25 patients are expected to enroll in each additional treatment arm. If Treatment Arm E or Treatment Arm F is discontinued subjects meeting certain criteria will have the option to enter a telaprevir-containing Rollover Phase. Subjects who do not meet the eligibility criteria to enter the Rollover Phase may elect to enter the Extension Phase.

Key facts

Study ID

NCT01080222

Run by

Vertex Pharmaceuticals Incorporated

People needed

152

Starts

2010-08-01

Expected to finish

2013-11-01

Last updated by the study team

2020-09-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females of non-childbearing potential
• Genotype 1 chronic hepatitis C
• Laboratory evidence of HCV infection for 6 months
• Histologic evidence of chronic hepatitis C
• Subjects who have a body mass index (BMI) of ≤35 kg/m² (BMI = weight in kg / height² in meters)
• Treatment Arm E: This arm will enroll only subjects infected with HCV genotype 1b virus
• Treatment Arm F: This arm will enroll only subjects infected with HCV genotype 1a virus

You may not qualify if…

• Subjects who have received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
• Subjects with any contraindications to peginterferon alfa-2a and/or ribavirin
• Subjects with 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 (NASH), or primary biliary cirrhosis
• Histologic evidence of hepatic cirrhosis

Where it is running

• Study site — Christchurch, New Zealand
• Study site — La Jolla, California, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Gainesville, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Lutherville, Maryland, United States
• Study site — Rochester, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Egg Harbor, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Providence, Rhode Island, United States
• Study site — Germantown, Tennessee, United States
• Study site — Arlington, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Falls Church, Virginia, United States
• Study site — Auckland, New Zealand

Full record on ClinicalTrials.gov

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