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

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®)

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Drug: telaprevir; Drug: ribavirin; Biological: peginterferon alfa-2a

• Study Type: Interventional
• Enrollment (Actual): 540
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: telaprevir; 750 mg every 8 hours (q8h) for 12 weeks; Other Names: VX-950; Drug: ribavirin; 1000 - 1200 mg/day based on body weight for either 24 or 48 weeks; Other Names: Copegus; Biological: peginterferon alfa-2a; 180 mcg/week for either 24 or 48 weeks; Other Names: Pegasys
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	Drug: telaprevir; 750 mg every 8 hours (q8h) for 12 weeks; Other Names: VX-950; Drug: ribavirin; 1000 - 1200 mg/day based on body weight for either 24 or 48 weeks; Other Names: Copegus; Biological: peginterferon alfa-2a; 180 mcg/week for either 24 or 48 weeks; Other Names: Pegasys
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	Drug: telaprevir; 750 mg every 8 hours (q8h) for 12 weeks; Other Names: VX-950; Drug: ribavirin; 1000 - 1200 mg/day based on body weight for either 24 or 48 weeks; Other Names: Copegus; Biological: peginterferon alfa-2a; 180 mcg/week for either 24 or 48 weeks; Other Names: Pegasys
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.	Drug: telaprevir; 750 mg every 8 hours (q8h) for 12 weeks; Other Names: VX-950; Drug: ribavirin; 1000 - 1200 mg/day based on body weight for either 24 or 48 weeks; Other Names: Copegus; Biological: peginterferon alfa-2a; 180 mcg/week for either 24 or 48 weeks; Other Names: Pegasys

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	24 weeks after the last planned dose of study treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	72 weeks after the last planned dose of study treatment
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).	Week 4 and Week 12
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.	12 weeks after last dose of study treatment
Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively)		Week 24 or Week 48
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).	From EOT to Week 48 or Week 72
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.	From EOT to Week 48 or Week 72
Safety and Tolerability as Assessed by Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Day 1 up to Week 72

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated
• Collaborators: Tibotec Pharmaceutical Limited
• Investigators: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: September 19, 2008
• First Submitted That Met QC Criteria: September 19, 2008
• First Posted (Estimate): September 23, 2008

Study Record Updates

• Last Update Posted (Actual): March 26, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Genotype 1
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Ribavirin; Peginterferon alfa-2a
• Other Study ID Numbers: VX08-950-111; EudraCT 2008-003836-39