search
Back to results

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

Primary Purpose

Hepatitis C

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Telaprevir
Ribavirin
Pegylated Interferon Alfa-2a
Sponsored by
Vertex Pharmaceuticals Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring VX-950, Incivek

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alabama
  • California
  • Connecticut
  • Washington, DC
  • Florida
  • Florida
  • Florida
  • Florida
  • Georgia
  • Illinois
  • Louisiana
  • Louisiana
  • Louisiana
  • Maryland
  • Massachusetts
  • Michigan
  • New Jersey
  • New York
  • New York
  • North Carolina
  • North Carolina
  • Pennsylvania
  • Texas
  • Texas
  • Texas
  • Virginia
  • Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Black

Non-Black

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)
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).

Secondary Outcome Measures

Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)
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)
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
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
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
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)
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
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.

Full Information

First Posted
November 3, 2011
Last Updated
July 13, 2015
Sponsor
Vertex Pharmaceuticals Incorporated
search

1. Study Identification

Unique Protocol Identification Number
NCT01467492
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
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.
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
VX-950, Incivek

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Black
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-Black
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Telaprevir
Other Intervention Name(s)
Incivek, VX-950
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus®, RBV
Intervention Description
Tablet
Intervention Type
Biological
Intervention Name(s)
Pegylated Interferon Alfa-2a
Other Intervention Name(s)
Pegasys®, Peg-IFN-Alfa-2a
Intervention Description
Subcutaneous Injection
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)
Description
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).
Time Frame
12 weeks after last actual dose of study drug (up to Week 60)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)
Description
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.
Time Frame
24 weeks after last actual dose of study drug (up to Week 72)
Title
Percentage of Participants With Extended Rapid Viral Response (eRVR)
Description
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.
Time Frame
Week 4 and Week 12
Title
Percentage of Participants With Relapse
Description
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.
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
Title
Percentage of Participants With Virologic Breakthrough
Description
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.
Time Frame
Week 2, 4, 8, and 12
Title
Percentage of Participants With On Treatment Virologic Failure
Description
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.
Time Frame
Week 2, 4, 8, 12, 16, 24, 28, 36, 40, and 48
Title
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to Week 52
Title
Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
Description
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.
Time Frame
up to Week 72
Other Pre-specified Outcome Measures:
Title
Plasma Concentration of Telaprevir, Peginterferon Alfa-2a (Peg-IFN) and Ribavirin (RBV)
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Vertex Pharmaceuticals Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Alabama
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
California
City
San Francisco
State/Province
California
Country
United States
Facility Name
Connecticut
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Washington, DC
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Florida
City
Miami
State/Province
Florida
Country
United States
Facility Name
Florida
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Florida
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Florida
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Georgia
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Illinois
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Louisiana
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Louisiana
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Louisiana
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Maryland
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Massachusetts
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Michigan
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
New Jersey
City
Vineland
State/Province
New Jersey
Country
United States
Facility Name
New York
City
Bronx
State/Province
New York
Country
United States
Facility Name
New York
City
New York
State/Province
New York
Country
United States
Facility Name
North Carolina
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
North Carolina
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Texas
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Texas
City
Houston
State/Province
Texas
Country
United States
Facility Name
Texas
City
San Antoinio
State/Province
Texas
Country
United States
Facility Name
Virginia
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Washington
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs