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Trial record 4 of 382 for:    IFNA2 AND RBV AND genotype

Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C

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ClinicalTrials.gov Identifier: NCT01467492
Recruitment Status : Terminated (It was decided by Sponsor on 13 January 2014 to terminate study early at primary efficacy endpoint as part of a decision to modify drug development plan.)
First Posted : November 8, 2011
Results First Posted : June 16, 2015
Last Update Posted : August 3, 2015
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Tracking Information
First Submitted Date  ICMJE November 3, 2011
First Posted Date  ICMJE November 8, 2011
Results First Submitted Date  ICMJE June 1, 2015
Results First Posted Date  ICMJE June 16, 2015
Last Update Posted Date August 3, 2015
Study Start Date  ICMJE January 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2015)
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12) [ Time Frame: 12 weeks after last actual dose of study drug (up to Week 60) ]
SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2011)
Proportion of subjects who achieve SVR 12 weeks after last actual dose of study drug, by prior response. [ Time Frame: 12 weeks after last actual dose of study drug ]
Change History Complete list of historical versions of study NCT01467492 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2015)
  • Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24) [ Time Frame: 24 weeks after last actual dose of study drug (up to Week 72) ]
    SVR24 was defined as an undetectable HCV RNA Levels (<lower limit of quantification) at 24 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.
  • Percentage of Participants With Extended Rapid Viral Response (eRVR) [ Time Frame: Week 4 and Week 12 ]
    The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.
  • Percentage of Participants With Relapse [ Time Frame: 4 weeks (Wk) (up to Week 52), 12 weeks (up to Week 60) and 24 weeks (up to Week 72) after actual EOT ]
    The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Relapse was defined as having undetectable HCV RNA (<lower limit of quantification) at actual end of treatment (EOT) and followed by detectable HCV RNA (>=lower limit of quantification) during follow-up.
  • Percentage of Participants With Virologic Breakthrough [ Time Frame: Week 2, 4, 8, and 12 ]
    The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Virologic breakthrough on treatment was defined as an increase of at least 1 log10 from nadir or confirmed detectable HCV RNA (>=lower limit of quantification) after undetectable HCV RNA (<lower limit of quantification). Percentages are calculated by using total number in FA set as denominator, in each category.
  • Percentage of Participants With On Treatment Virologic Failure [ Time Frame: Week 2, 4, 8, 12, 16, 24, 28, 36, 40, and 48 ]
    On treatment virologic failure was defined as meeting any futility rule or completing assigned treatment duration and having detectable HCV RNA at EOT. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Futility rules: 1) Virologic breakthrough (at least 1 log10 increase from nadir or confirmed detectable HCV RNA after undetectable HCV RNA) from Day 1 through Week 24 or 48 (depending on treatment duration); 2) HCV RNA >1000 IU/mL during Weeks 4 to 12, inclusive; 3) Detectable HCV RNA after Week 12. Percentages are calculated by using total number in FA set as denominator, in each category.
  • Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 52 ]
    AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes SAE as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.
  • Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region [ Time Frame: up to Week 72 ]
    Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by race and by prior response.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2011)
  • Proportion of subjects who achieve SVR 24 weeks after last actual dose of study drug by prior response. [ Time Frame: 24 weeks after last actual dose of study drug ]
  • Proportion of subjects who achieve undetectable HCV RNA at Week 4 and at Week 12 (eRVR) by prior response [ Time Frame: up to Week 12 ]
  • Proportion of subjects who relapse, overall and by treatment completion status, defined as having undetectable HCV RNA at actual end of treatment followed by detectable HCV RNA during follow-up, by prior response [ Time Frame: up to Week 72 ]
  • Proportion of subjects who have on-treatment virologic failure, defined as meeting futility rule or completing assigned treatment duration and having detectable HCV RNA at the end of treatment, prior response. [ Time Frame: up to Week 48 ]
  • Safety as indicated by adverse events, clinical laboratory results, electrocardiograms and vital signs [ Time Frame: up to Week 52 ]
  • Amino acid sequence of the HCV NS34A protease region [ Time Frame: Baseline up through 48 weeks after subject becomes detectable ]
  • Pharmacokinetics of telaprevir, Peg-IFN and RBV [ Time Frame: up to Week 12 ]
  • Proportion of subjects who experience viral breakthrough,defined as having ≥1 log increase from nadir or confirmed detectable HCV RNA after undetectable HCV RNA, by prior response. [ Time Frame: up to 48 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: June 1, 2015)
Plasma Concentration of Telaprevir, Peginterferon Alfa-2a (Peg-IFN) and Ribavirin (RBV) [ Time Frame: 48 weeks ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C
Official Title  ICMJE An Open-Label, Phase 4 Study of Telaprevir, Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C Who Have Not Achieved a Sustained Viral Response With a Prior Course of Interferon-Based Therapy
Brief Summary The purpose of this study is to evaluate the efficacy and safety of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in treatment-experienced Black/African American and non-Black/African American participants with Genotype 1 Chronic Hepatitis C (CHC), who have not achieved a sustained viral response with a prior course of interferon-based therapy.
Detailed Description

This is a single-arm, open-label, multicenter study of treatment-experienced participants with Genotype 1 CHC, who self-identified as Black/African American (Group A) or who did not self-identify as Black/African American (Group B). Participants did not achieve a sustained virologic response 24 weeks after at least 1 prior course of Peg-IFN-alfa-2a/RBV therapy of standard duration, and have 1 of the following viral responses:

  • Prior relapse: Participant had a documented undetectable hepatitis C virus ribonucleic acid (HCV RNA) level at the planned end of treatment of at least 42 weeks duration (HCV RNA evaluated anytime between 3 weeks before and 6 weeks after the last dose of Peg IFN-alfa-2a or RBV).
  • Prior null response: Participant had a <2-log10 decrease in HCV RNA at 12 weeks, during prior Peg IFN-alfa-2a/RBV treatment, but never achieved undetectable HCV RNA while on treatment.
  • Prior partial response: Participant had a >=2-log10 decrease in HCV RNA at 12 weeks, during prior Peg IFN-alfa-2a/RBV treatment, but never achieved undetectable HCV RNA while on treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: Telaprevir
    Tablet
    Other Name: Incivek, VX-950
  • Drug: Ribavirin
    Tablet
    Other Name: Copegus®, RBV
  • Biological: Pegylated Interferon Alfa-2a
    Subcutaneous Injection
    Other Name: Pegasys®, Peg-IFN-Alfa-2a
Study Arms  ICMJE
  • Experimental: Black
    Telaprevir 750 milligram (mg) tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 microgram per week (mcg/week) subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 milligram per day (mg/day) (for participants weighing <75 kilograms [kg]) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
    Interventions:
    • Drug: Telaprevir
    • Drug: Ribavirin
    • Biological: Pegylated Interferon Alfa-2a
  • Experimental: Non-Black
    Telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
    Interventions:
    • Drug: Telaprevir
    • Drug: Ribavirin
    • Biological: Pegylated Interferon Alfa-2a
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: July 10, 2014)
121
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2011)
220
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants self-identify as Black/African American (Group A) or did not self-identify as Black/African American (Group B)
  • Participants have Genotype 1 CHC and laboratory evidence of hepatitis C virus (HCV) infection for at least 6 months
  • Participants did not achieve sustained viral response 24 weeks after last dose of study drug (SVR24), after at least 1 prior course of Peg-IFN-alfa-2a/RBV therapy of standard duration

Exclusion Criteria:

  • Participants have received previous treatment with telaprevir or any other protease inhibitor(s) for CHC
  • Participants who have evidence of hepatic decompensation
  • Participants have diagnosed or suspected hepatocellular carcinoma
  • Participants have any other cause of significant liver disease in addition to HCV
  • Participants are currently abusing illicit drugs or alcohol, or have history of illicit substance or alcohol abuse within 2 years before the screening visit
  • Participants who participated in any investigational drug study within 90 days before dosing
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01467492
Other Study ID Numbers  ICMJE VX11-950-116
Has Data Monitoring Committee No
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 Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
PRS Account Vertex Pharmaceuticals Incorporated
Verification Date June 2015

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