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: July 2, 2014
Last verified: July 2014

April 17, 2012
July 2, 2014
July 2012
June 2013   (final data collection date for primary outcome measure)
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 ]
The proportion of subjects who have a sustained viral response 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 ]
Complete list of historical versions of study NCT01581138 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 <LLOQ 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 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 ]
Not Provided
Not Provided
 
VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C Virus
  • 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: 12 week treatment
    Interventions:
    • Drug: VX-222
    • Drug: telaprevir
    • Drug: ribavirin
  • Experimental: 16 week treatment
    Interventions:
    • Drug: VX-222
    • Drug: telaprevir
    • Drug: ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
December 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01581138
VX11-222-108
No
Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Not Provided
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP