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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01581138
First Posted: April 20, 2012
Last Update Posted: July 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Time to achieve <LLOQ undetectable HCV RNA [ Time Frame: up to 16 weeks ]
  • 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 ]
  • 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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01581138     History of Changes
Other Study ID Numbers: VX11-222-108
First Submitted: April 17, 2012
First Posted: April 20, 2012
Last Update Posted: July 4, 2014
Last Verified: July 2014

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