Telaprevir in Combination With Peginterferon and Ribavirin in Treatment-experienced Black/African American Subjects.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01467492
First received: November 3, 2011
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to collect additional data in treatment-experienced Black/African Americans that can be used to guide treatment decisions in this patient population.


Condition Intervention Phase
Hepatitis C
Drug: Telaprevir
Drug: ribavirin
Biological: peginterferon alfa-2a
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety as indicated by adverse events, clinical laboratory results, electrocardiograms and vital signs [ Time Frame: up to Week 52 ] [ Designated as safety issue: Yes ]
  • Amino acid sequence of the HCV NS34A protease region [ Time Frame: Baseline up through 48 weeks after subject becomes detectable ] [ Designated as safety issue: No ]
  • Pharmacokinetics of telaprevir, Peg-IFN and RBV [ Time Frame: up to Week 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: January 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Relapsers (eRVR+)

Relapsers (eRVR+):Telaprevir + peginterferon alfa-2a + ribavirin (RBV) for 12 weeks followed by peginterferon alfa-2a + RBV for 12 weeks

eRVR+: undetectable HCV RNA at Weeks 4 and 12

Drug: Telaprevir
1125mg tablets for 12 weeks
Other Name: Incivek, VX-950
Drug: ribavirin
1000mg-1200mg based on body weight for 24 weeks
Other Name: Copegus
Biological: peginterferon alfa-2a
180 mcg/week for 24 weeks
Other Name: Pegasys
Experimental: Relapsers (eRVR-)

Telaprevir + peginterferon alfa-2a + ribavirin (RBV) for 12 weeks, followed by peginterferon alfa-2a + RBV for 36 weeks

eRVR-: undetectable HCV RNA at Weeks 4 and 12

Drug: Telaprevir
1125mg tablets for 12 weeks
Other Name: Incivek, VX-950
Drug: ribavirin
1000mg-1200mg based on body weight for 48 weeks
Other Name: Copegus
Biological: peginterferon alfa-2a
180 mcg/week for 48 weeks
Other Name: Pegasys
Experimental: Null/Partial
All Null/Partial subjects receive Telaprevir + peginterferon alfa-2a + ribavirin (RBV) for 12 weeks, followed by peginterferon alfa-2a + RBV for 36 weeks
Drug: Telaprevir
1125mg tablets for 12 weeks
Other Name: Incivek, VX-950
Drug: ribavirin
1000mg-1200mg based on body weight for 48 weeks
Other Name: Copegus
Biological: peginterferon alfa-2a
180 mcg/week for 48 weeks
Other Name: Pegasys
Experimental: Other
Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 12
Drug: Telaprevir
1125mg tablets for 12 weeks
Other Name: Incivek, VX-950
Drug: ribavirin
1000mg-1200mg 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

  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
  • Subjects self-identify as Black/African American
  • Subjects have genotype 1 CHC and laboratory evidence of HCV infection for at least 6 months
  • Subjects did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV therapy of standard duration

Exclusion Criteria:

  • Subjects have received previous treatment with telaprevir or any other protease inhibitor(s) for CHC
  • Subjects who have evidence of hepatic decompensation
  • Subjects have diagnosed or suspected hepatocellular carcinoma
  • Subjects have any other cause of significant liver disease in addition to HCV
  • Subjects are currently abusing illicit drugs or alcohol, or have history of illicit substance or alcohol abuse within 2 years before the screening visit
  • Subjects who participated in any investigational drug study within 90 days before dosing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467492

  Show 27 Study Locations
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
  More Information

No publications provided

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01467492     History of Changes
Other Study ID Numbers: VX11-950-116
Study First Received: November 3, 2011
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Vertex Pharmaceuticals Incorporated:
VX-950, Incivek

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
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 April 23, 2014