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A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response

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ClinicalTrials.gov Identifier: NCT00758043
Recruitment Status : Completed
First Posted : September 23, 2008
Results First Posted : July 21, 2011
Last Update Posted : March 26, 2021
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Tracking Information
First Submitted Date  ICMJE September 19, 2008
First Posted Date  ICMJE September 23, 2008
Results First Submitted Date  ICMJE June 22, 2011
Results First Posted Date  ICMJE July 21, 2011
Last Update Posted Date March 26, 2021
Actual Study Start Date  ICMJE October 2008
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2013)
Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24) [ Time Frame: 24 weeks after the last planned dose of study treatment ]
SVR24planned was used to measure the primary outcome. SVR24 planned is defined as undetectable HCV RNA levels at the end of treatment (EOT) visit and at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA levels in between those visits. All plasma HCV RNA levels were assessed using the Roche TaqMan HCV RNA assay (Version 2.0, lower limit of quantification [LLOQ] of 25 IU/mL).
Original Primary Outcome Measures  ICMJE
 (submitted: September 19, 2008)
To demonstrate the efficacy of telaprevir in combination with Pegasys® and Copegus® in treatment naive subjects with genotype 1 chronic hepatitis C. [ Time Frame: Prospective ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2021)
  • Proportion of Subjects Who Have Undetectable HCV RNA at Week 72 [ Time Frame: 72 weeks after the last planned dose of study treatment ]
    SVR at Week 72 is defined as achieved SVR24planned and undetectable HCV RNA at Week 72 without any confirmed detectable HCV RNA levels in between those visits.
  • Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12 [ Time Frame: Week 4 and Week 12 ]
    Extended rapid viral response is defined undetectable HCV RNA levels at Week 4 and Week 12 (on treatment).
  • Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment [ Time Frame: 12 weeks after last dose of study treatment ]
    SVR12 is defined as undetectable HCV RNA levels 12 weeks after the last planned dose of study treatment.
  • Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively) [ Time Frame: Week 24 or Week 48 ]
  • Proportion of Randomized Subjects Who Relapse [ Time Frame: From EOT to Week 48 or Week 72 ]
    Proportion of randomized subjects who relapsed was defined as the number of subjects who completed treatment, had undetectable HCV RNA at end of treatment (EOT; Week 24 or Week 48 respectively), and became HCV RNA detectable during antiviral follow-up (24 weeks after EOT).
  • Proportion of Enrolled Subjects Who Relapse [ Time Frame: From EOT to Week 48 or Week 72 ]
    Proportion of enrolled subjects who relapsed was defined as the number of subjects who had undetectable HCV RNA at the EOT, and became HCV RNA detectable during antiviral follow-up.
  • Safety and Tolerability as Assessed by Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to Week 72 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2008)
To evaluate the safety of telaprevir in combination with Pegasys® and Copegus® in treatment naive subjects with genotype 1 chronic hepatitis C. [ Time Frame: Prospective ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response
Official Title  ICMJE A Randomized Study of Stopping Treatment at 24 Weeks or Continuing Treatment to 48 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response While Receiving Telaprevir, Peginterferon Alfa2a (Pegasys®) and Ribavirin (Copegus®)
Brief Summary This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: telaprevir
    750 mg every 8 hours (q8h) for 12 weeks
    Other Name: VX-950
  • Drug: ribavirin
    1000 - 1200 mg/day based on body weight for either 24 or 48 weeks
    Other Name: Copegus
  • Biological: peginterferon alfa-2a
    180 mcg/week for either 24 or 48 weeks
    Other Name: Pegasys
Study Arms  ICMJE
  • Experimental: T12PR24 (eRVR+)
    Randomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 12 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
    Interventions:
    • Drug: telaprevir
    • Drug: ribavirin
    • Biological: peginterferon alfa-2a
  • Experimental: T12PR48 (eRVR+)
    Randomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
    Interventions:
    • Drug: telaprevir
    • Drug: ribavirin
    • Biological: peginterferon alfa-2a
  • Experimental: T12PR48 (eRVR-)
    Assigned Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects did not achieve an extended rapid viral response and were assigned to this group
    Interventions:
    • Drug: telaprevir
    • Drug: ribavirin
    • Biological: peginterferon alfa-2a
  • Experimental: Other
    Other Group: Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen.
    Interventions:
    • Drug: telaprevir
    • Drug: ribavirin
    • Biological: peginterferon alfa-2a
Publications * Sherman KE, Flamm SL, Afdhal NH, Nelson DR, Sulkowski MS, Everson GT, Fried MW, Adler M, Reesink HW, Martin M, Sankoh AJ, Adda N, Kauffman RS, George S, Wright CI, Poordad F; ILLUMINATE Study Team. Response-guided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med. 2011 Sep 15;365(11):1014-24. doi: 10.1056/NEJMoa1014463. Erratum in: N Engl J Med. 2011 Oct 20;365(16):1551.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2013)
540
Original Estimated Enrollment  ICMJE
 (submitted: September 19, 2008)
500
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
  • Male and female subjects, 18 to 70 years of age, inclusive
  • Genotype 1, chronic hepatitis C with detectable HCV RNA.
  • Screening laboratory values, tests, and physical exam within acceptable ranges
  • Able and willing to follow contraception requirements
  • Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions.

Exclusion Criteria:

  • Subject has any contraindications to Pegasys® or Copegus® therapy
  • Evidence of hepatic decompensation in cirrhotic subjects
  • History of organ transplant
  • History of, or any current medical condition which could impact the safety of the subject in participation in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Netherlands,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00758043
Other Study ID Numbers  ICMJE VX08-950-111
EudraCT 2008-003836-39
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vertex Pharmaceuticals Incorporated
Study Sponsor  ICMJE Vertex Pharmaceuticals Incorporated
Collaborators  ICMJE Tibotec Pharmaceutical Limited
Investigators  ICMJE
Principal Investigator: Michael Adler, MD, PhD Erasmus Hospital Bruxelles
Principal Investigator: Hendrik Reesink, MD, PhD Academic Medical Center of the University of Amsterdam
Principal Investigator: Kenneth Sherman, MD, PhD University of Cincinnati
PRS Account Vertex Pharmaceuticals Incorporated
Verification Date March 2021

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