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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

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
telaprevir
ribavirin
peginterferon 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 Genotype 1

Eligibility Criteria

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

T12PR24 (eRVR+)

T12PR48 (eRVR+)

T12PR48 (eRVR-)

Other

Arm Description

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

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

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

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.

Outcomes

Primary Outcome Measures

Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24)
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).

Secondary Outcome Measures

Proportion of Subjects Who Have Undetectable HCV RNA at Week 72
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
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
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)
Proportion of Randomized Subjects Who Relapse
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
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)

Full Information

First Posted
September 19, 2008
Last Updated
March 3, 2021
Sponsor
Vertex Pharmaceuticals Incorporated
Collaborators
Tibotec Pharmaceutical Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00758043
Brief Title
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
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®)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 2008 (Actual)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated
Collaborators
Tibotec Pharmaceutical Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Genotype 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
540 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T12PR24 (eRVR+)
Arm Type
Experimental
Arm Description
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
Arm Title
T12PR48 (eRVR+)
Arm Type
Experimental
Arm Description
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
Arm Title
T12PR48 (eRVR-)
Arm Type
Experimental
Arm Description
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
Arm Title
Other
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
telaprevir
Other Intervention Name(s)
VX-950
Intervention Description
750 mg every 8 hours (q8h) for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ribavirin
Other Intervention Name(s)
Copegus
Intervention Description
1000 - 1200 mg/day based on body weight for either 24 or 48 weeks
Intervention Type
Biological
Intervention Name(s)
peginterferon alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
180 mcg/week for either 24 or 48 weeks
Primary Outcome Measure Information:
Title
Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24)
Description
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).
Time Frame
24 weeks after the last planned dose of study treatment
Secondary Outcome Measure Information:
Title
Proportion of Subjects Who Have Undetectable HCV RNA at Week 72
Description
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.
Time Frame
72 weeks after the last planned dose of study treatment
Title
Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12
Description
Extended rapid viral response is defined undetectable HCV RNA levels at Week 4 and Week 12 (on treatment).
Time Frame
Week 4 and Week 12
Title
Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment
Description
SVR12 is defined as undetectable HCV RNA levels 12 weeks after the last planned dose of study treatment.
Time Frame
12 weeks after last dose of study treatment
Title
Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively)
Time Frame
Week 24 or Week 48
Title
Proportion of Randomized Subjects Who Relapse
Description
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).
Time Frame
From EOT to Week 48 or Week 72
Title
Proportion of Enrolled Subjects Who Relapse
Description
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.
Time Frame
From EOT to Week 48 or Week 72
Title
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

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Adler, MD, PhD
Organizational Affiliation
Erasmus Hospital Bruxelles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hendrik Reesink, MD, PhD
Organizational Affiliation
Academic Medical Center of the University of Amsterdam
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth Sherman, MD, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92115
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20783
Country
United States
City
Laurel
State/Province
Maryland
ZIP/Postal Code
20707
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
City
Atlantic City
State/Province
New Jersey
ZIP/Postal Code
08401
Country
United States
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
City
Bayside
State/Province
New York
ZIP/Postal Code
11358
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
City
Brussels
ZIP/Postal Code
B1070
Country
Belgium
City
Brussels
ZIP/Postal Code
B1200
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Liège 1
ZIP/Postal Code
4000
Country
Belgium
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
City
Amsterdam
ZIP/Postal Code
1100 DE
Country
Netherlands
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
City
Santurce
ZIP/Postal Code
00909
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
21916639
Citation
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.
Results Reference
derived

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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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