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®)
2 other identifiers
interventional
540
4 countries
82
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2008
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2008
CompletedFirst Posted
Study publicly available on registry
September 23, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
July 21, 2011
CompletedMarch 26, 2021
March 1, 2021
1.7 years
September 19, 2008
June 22, 2011
March 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Proportion of Subjects Who Have Undetectable HCV RNA at Week 72
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
Week 4 and Week 12
Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last 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
From EOT to Week 48 or Week 72
- +2 more secondary outcomes
Study Arms (4)
T12PR24 (eRVR+)
EXPERIMENTALRandomized 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
T12PR48 (eRVR+)
EXPERIMENTALRandomized 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
T12PR48 (eRVR-)
EXPERIMENTALAssigned 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
EXPERIMENTALOther 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.
Interventions
750 mg every 8 hours (q8h) for 12 weeks
1000 - 1200 mg/day based on body weight for either 24 or 48 weeks
180 mcg/week for either 24 or 48 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (82)
Unknown Facility
Birmingham, Alabama, 35209, United States
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Birmingham, Alabama, 35294, United States
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Phoenix, Arizona, 85054, United States
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Fresno, California, 93721, United States
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La Jolla, California, 92037, United States
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Los Angeles, California, 90048, United States
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Sacramento, California, 95817, United States
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San Diego, California, 92115, United States
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San Diego, California, 92123, United States
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San Francisco, California, 94115, United States
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San Francisco, California, 94143, United States
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Aurora, Colorado, 80045, United States
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Farmington, Connecticut, 06030, United States
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Washington D.C., District of Columbia, 20010, United States
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Gainesville, Florida, 32610, United States
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Jacksonville, Florida, 32224, United States
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Miami, Florida, 33136, United States
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Orlando, Florida, 32803, United States
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Sarasota, Florida, 34243, United States
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Wellington, Florida, 33414, United States
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Atlanta, Georgia, 30308, United States
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Atlanta, Georgia, 30309, United States
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Marietta, Georgia, 30060, United States
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Honolulu, Hawaii, 96817, United States
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Chicago, Illinois, 60611, United States
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Chicago, Illinois, 60612, United States
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Downers Grove, Illinois, 60515, United States
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Indianapolis, Indiana, 46202, United States
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New Orleans, Louisiana, 70112, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21287, United States
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Hyattsville, Maryland, 20783, United States
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Laurel, Maryland, 20707, United States
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Boston, Massachusetts, 02111, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02215, United States
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Worcester, Massachusetts, 01655, United States
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Detroit, Michigan, 48202, United States
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Novi, Michigan, 48377, United States
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Rochester, Minnesota, 55905, United States
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Kansas City, Missouri, 64131, United States
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St Louis, Missouri, 63104, United States
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St Louis, Missouri, 63110, United States
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Lebanon, New Hampshire, 03756, United States
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Atlantic City, New Jersey, 08401, United States
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Egg Harbor, New Jersey, 08234, United States
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Albuquerque, New Mexico, 87131, United States
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Bayside, New York, 11358, United States
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Manhasset, New York, 11030, United States
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New York, New York, 10016, United States
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New York, New York, 10021, United States
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New York, New York, 10029, United States
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New York, New York, 10032, United States
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The Bronx, New York, 10467, United States
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Chapel Hill, North Carolina, 27599, United States
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Durham, North Carolina, 27710, United States
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Statesville, North Carolina, 28677, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45267, United States
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Cleveland, Ohio, 44109, United States
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Portland, Oregon, 97239, United States
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Philadelphia, Pennsylvania, 19141, United States
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Providence, Rhode Island, 02905, United States
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Columbia, South Carolina, 29204, United States
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Germantown, Tennessee, 38138, United States
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Dallas, Texas, 75203, United States
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Dallas, Texas, 75246, United States
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San Antonio, Texas, 78215, United States
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Salt Lake City, Utah, 84132, United States
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Falls Church, Virginia, 22042, United States
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Seattle, Washington, 98104, United States
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Tacoma, Washington, 98405, United States
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Madison, Wisconsin, 53792, United States
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Milwaukee, Wisconsin, 53226, United States
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Brussels, B1070, Belgium
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Brussels, B1200, Belgium
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Ghent, 9000, Belgium
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Liège, 4000, Belgium
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Amsterdam, 1081 HV, Netherlands
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Amsterdam, 1100 DE, Netherlands
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Arnhem, 6815 AD, Netherlands
Unknown Facility
Santurce, 00909, Puerto Rico
Related Publications (1)
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.
PMID: 21916639DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Kauffman, MD, PhD
- Organization
- Vertex Pharmaceuticals Incorporated
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2008
First Posted
September 23, 2008
Study Start
October 1, 2008
Primary Completion
June 1, 2010
Study Completion
July 1, 2010
Last Updated
March 26, 2021
Results First Posted
July 21, 2011
Record last verified: 2021-03