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Efficacy of a 12-week Regimen of Telaprevir, Peginterferon, and Ribavirin in Subjects With Interleukin-28B (IL28B) CC Genotype in Treatment-naive and Prior Relapser Subjects (CONCISE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01459913
First received: October 24, 2011
Last updated: November 5, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with peginterferon and ribavirin (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV) infection and will not have cirrhosis of the liver.


Condition Intervention Phase
Hepatitis C, Chronic
 Drug: telaprevir
Drug: Peginterferon alfa-2a
Drug: ribavirin
 Phase 3

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 Phase 3b Study of 2 Treatment Durations of Telaprevir, Peg-IFN (Pegasys®), and Ribavirin (Copegus®) in Treatment-Naive and Prior Relapser Subjects With Genotype 1 Chronic Hepatitis C and IL28B CC Genotype

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Proportion of subjects assigned to the 12-week regimen of telaprevir, Peg-IFN, and RBV (T12/PR12) who have sustained viral response (SVR) 12 weeks after last planned dose of study drug (SVR12) [ Time Frame: 12 weeks after last planned dose of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects who have SVR 24 weeks after last planned dose of study drug (SVR24) [ Time Frame: 24 weeks after last planned dose of study drug ] [ Designated as safety issue: No ]
  • Proportion of subjects who have SVR at Week 72 [ Time Frame: 72 weeks after last planned dose of study drug ] [ Designated as safety issue: No ]
  • Proportion of subjects who have relapse overall and by treatment completion status [ Time Frame: Every 12 weeks from last planned dose through Week 72 ] [ Designated as safety issue: No ]
  • Proportion of subjects who have on-treatment virologic failure [ Time Frame: Week 1 through Week 48 of planned treatment ] [ Designated as safety issue: No ]
  • Safety as indicated by adverse events (AEs), clinical laboratory results, electrocardiograms (ECG), and vital signs [ Time Frame: Start of treatment period through 4 weeks after last administered dose of last study drug ] [ Designated as safety issue: Yes ]
  • Amino acid sequence of the HCV NS3•4A protease domain [ Time Frame: Duration of treatment period; 12 and 24 weeks after last planned dose, and at Week 72 ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: December 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T12/PR12
Subjects who have rapid viral response (RVR), do not permanently discontinue treatment of any study drug before Week 12, and are randomized to receive a total Peg-IFN/RBV treatment duration of 12 weeks (T12/PR12).
 Drug: telaprevir
1125 mg administered orally twice daily for 12 weeks
Other Names:
  • INCIVEK
  • INCIVO
Drug: Peginterferon alfa-2a
180 micrograms administered subcutaneously once weekly for either 12, 24, or 48 weeks depending on protocol defined treatment response or randomization
Other Name: Pegasys
Drug: ribavirin
  • 1000 mg administered orally twice daily for subjects weighing < 75 kg for either 12, 24, or 48 weeks depending on protocol defined treatment response or randomization
  • 1200 mg administered orally twice daily for subjects weighing ≥ 75 kg for either 12, 24, or 48 weeks depending on protocol defined treatment response or randomization
Other Name: Copegus
Experimental: T12/PR24
Subjects who have rapid viral response (RVR), do not permanently discontinue treatment of any study drug before Week 12, and are randomized to receive a total Peg-IFN/RBV treatment duration of 24 weeks (T12/PR24).
 Drug: telaprevir
1125 mg administered orally twice daily for 12 weeks
Other Names:
  • INCIVEK
  • INCIVO
Drug: Peginterferon alfa-2a
180 micrograms administered subcutaneously once weekly for either 12, 24, or 48 weeks depending on protocol defined treatment response or randomization
Other Name: Pegasys
Drug: ribavirin
  • 1000 mg administered orally twice daily for subjects weighing < 75 kg for either 12, 24, or 48 weeks depending on protocol defined treatment response or randomization
  • 1200 mg administered orally twice daily for subjects weighing ≥ 75 kg for either 12, 24, or 48 weeks depending on protocol defined treatment response or randomization
Other Name: Copegus
Experimental: Other

All other subjects (subjects with no RVR, subjects with no RVR assessment, and subjects with RVR who permanently discontinue telaprevir, pegylated interferon or ribavirin treatment before Week 12) will have a planned total pegylated interferon/ribavirin treatment duration that depends on response-guided treatment criteria:

  • Subjects who have undetectable HCV RNA at Weeks 4 and 12 (eRVR) will have a planned total pegylated interferon and ribavirin treatment duration of 24 weeks (T12/PR24 regimen).
  • Subjects who do not have eRVR (or are missing eRVR assessment) will have a planned total pegylated interferon and ribavirin treatment duration of 48 weeks (T12/PR48 regimen).
 Drug: telaprevir
1125 mg administered orally twice daily for 12 weeks
Other Names:
  • INCIVEK
  • INCIVO
Drug: Peginterferon alfa-2a
180 micrograms administered subcutaneously once weekly for either 12, 24, or 48 weeks depending on protocol defined treatment response or randomization
Other Name: Pegasys
Drug: ribavirin
  • 1000 mg administered orally twice daily for subjects weighing < 75 kg for either 12, 24, or 48 weeks depending on protocol defined treatment response or randomization
  • 1200 mg administered orally twice daily for subjects weighing ≥ 75 kg for either 12, 24, or 48 weeks depending on protocol defined treatment response or randomization
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:

  • Male and female subjects, 18 to 70 years of age, inclusive
  • Treatment-naive OR subjects (prior relapsers) may be included who did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and had a documented undetectable HCV RNA level at the planned end of treatment of at least 42-week duration
  • Subjects have IL28B CC genotype determined during screening
  • Subjects have genotype 1 chronic hepatitis C and laboratory evidence of HCV infection for at least 6 months, defined by (1) documented HCV serology test at least 6 months before the first screening visit demonstrating the presence of anti-HCV antibody, or (2) documented presence of HCV RNA by a sensitive and specific assay at least 6 months before the first screening visit, or (3) documented histologic evidence of chronic hepatitis C demonstrated by fibrosis on a standardized histologic grading system at least 6 months before the first screening visit. If only inflammation is present in the liver histologic report, then 6 months of laboratory evidence is required.

Exclusion Criteria:

  • Subjects have received previous treatment with telaprevir or any other protease inhibitor(s) for chronic hepatitis C.
  • Subjects who did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and never achieved undetectable HCV RNA while on treatment
  • Subjects have evidence of hepatic decompensation
  • Subjects have evidence of cirrhosis
  • Subjects have diagnosed or suspected hepatocellular carcinoma
  • Subjects have 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. Steatosis is allowed if clinically asymptomatic
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459913

  Show 83 Study Locations
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Study Director: Mark Friedman, M.D. Vertex Pharmaceuticals Incorporated
  More Information

No publications provided

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01459913     History of Changes
Other Study ID Numbers: VX11-950-114
Study First Received: October 24, 2011
Last Updated: November 5, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Austria: Agency for Health and Food Safety
Israel: Ministry of Health

Keywords provided by Vertex Pharmaceuticals Incorporated:
VX-950
INCIVEK
INCIVO

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
 Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013