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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01581138
First received: April 17, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C Virus
Drug: VX-222
Drug: telaprevir
Drug: ribavirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-label, Phase 2b Study to Evaluate the Efficacy and Safety of Two Regimens of All-oral Triple Therapy (VX-222 in Combination With Telaprevir [Incivek™] and Ribavirin [Copegus®]) in Treatment-Naïve Subjects With Genotype 1a Chronic Hepatitis C

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • The proportion of subjects who have a sustained viral response (SVR) at 12 weeks after the last planned dose of treatment [ Time Frame: 12 weeks after the last planned dose of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis) [ Time Frame: up to 20 weeks ] [ Designated as safety issue: Yes ]
  • The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug [ Time Frame: 24 weeks after the last planned dose of the study drug ] [ Designated as safety issue: No ]
  • The proportion of subjects who have an SVR 4 weeks after the last planned dose of the study drug [ Time Frame: 4 weeks after the last planned dose of the study drug ] [ Designated as safety issue: No ]
  • The proportion of subjects who relapse (i.e., who had <lower limit of quantitation LLOQ hepatitis C virus (HCV) RNA at the end of planned study drug treatment (planned EOT) followed by ≥LLOQ HCV RNA after planned EOT) [ Time Frame: 48 weeks either after the last planned dose of study drug or after time of failure ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve undetectable HCV RNA (below the lower limit of detection (< (LLOQ) undetectable) at Weeks 2, 4, 8, 12, and 16 after the first dose of study drug, and <LLOQ at the end of planned study drug treatment (planned EOT) [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
  • Time to achieve <LLOQ undetectable HCV RNA [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects who have on-treatment virologic failure defined as subjects who either have viral breakthrough or who complete the assigned treatment and have ≥LLOQ HCV RNA at the end of study drug treatment (EOT) [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
  • The association of the interleukin-28B (IL-28B) genotype (CC versus CT versus TT) with SVR12 [ Time Frame: 12 weeks after the last planned dose of treatment ] [ Designated as safety issue: No ]
  • The amino acid sequence of the nonstructural (NS)3/4A and NS5B proteins in subjects who have treatment failure [ Time Frame: 48 weeks either after the last planned dose of study drug or after time of failure ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: July 2012
Study Completion Date: December 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 12 week treatment Drug: VX-222
400 mg tablets twice daily for oral administration
Drug: telaprevir
1125 mg tablets twice daily for oral administration
Other Name: VX-950, INCIVEK, INCIVO, TELAVIC
Drug: ribavirin
1000 mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily
Other Name: Copegus
Experimental: 16 week treatment Drug: VX-222
400 mg tablets twice daily for oral administration
Drug: telaprevir
1125 mg tablets twice daily for oral administration
Other Name: VX-950, INCIVEK, INCIVO, TELAVIC
Drug: ribavirin
1000 mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily
Other Name: Copegus

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581138

Locations
United States, Alabama
Birmingham, Alabama, United States
United States, California
Anaheim, California, United States
Riverside, California, United States
San Diego, California, United States
United States, Colorado
Englewood, Colorado, United States
United States, Florida
Orlando, Florida, United States
United States, Georgia
Marietta, Georgia, United States
United States, Maryland
Baltimore, Maryland, United States
United States, New York
New York, New York, United States
United States, North Carolina
Asheville, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Cincinatti, Ohio, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Germantown, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Austin, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Norfolk, Virginia, United States
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
  More Information

No publications provided

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01581138     History of Changes
Other Study ID Numbers: VX11-222-108
Study First Received: April 17, 2012
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014