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
NCT ID: NCT00758043
Last Updated: 2021-03-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
540 participants
INTERVENTIONAL
2008-10-31
2010-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype
NCT01459913
A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)
NCT00627926
An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants
NCT00528528
A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment
NCT00703118
A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C
NCT01482390
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
telaprevir
750 mg every 8 hours (q8h) for 12 weeks
ribavirin
1000 - 1200 mg/day based on body weight for either 24 or 48 weeks
peginterferon alfa-2a
180 mcg/week for either 24 or 48 weeks
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
telaprevir
750 mg every 8 hours (q8h) for 12 weeks
ribavirin
1000 - 1200 mg/day based on body weight for either 24 or 48 weeks
peginterferon alfa-2a
180 mcg/week for either 24 or 48 weeks
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
telaprevir
750 mg every 8 hours (q8h) for 12 weeks
ribavirin
1000 - 1200 mg/day based on body weight for either 24 or 48 weeks
peginterferon alfa-2a
180 mcg/week for either 24 or 48 weeks
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.
telaprevir
750 mg every 8 hours (q8h) for 12 weeks
ribavirin
1000 - 1200 mg/day based on body weight for either 24 or 48 weeks
peginterferon alfa-2a
180 mcg/week for either 24 or 48 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
telaprevir
750 mg every 8 hours (q8h) for 12 weeks
ribavirin
1000 - 1200 mg/day based on body weight for either 24 or 48 weeks
peginterferon alfa-2a
180 mcg/week for either 24 or 48 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tibotec Pharmaceutical Limited
INDUSTRY
Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Adler, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Hospital Bruxelles
Hendrik Reesink, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Academic Medical Center of the University of Amsterdam
Kenneth Sherman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Fresno, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
San Francisco, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Farmington, Connecticut, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Sarasota, Florida, United States
Wellington, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Downers Grove, Illinois, United States
Indianapolis, Indiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Hyattsville, Maryland, United States
Laurel, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Detroit, Michigan, United States
Novi, Michigan, United States
Rochester, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Lebanon, New Hampshire, United States
Atlantic City, New Jersey, United States
Egg Harbor, New Jersey, United States
Albuquerque, New Mexico, United States
Bayside, New York, United States
Manhasset, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
The Bronx, New York, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Statesville, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Columbia, South Carolina, United States
Germantown, Tennessee, United States
Dallas, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Falls Church, Virginia, United States
Seattle, Washington, United States
Tacoma, Washington, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Brussels, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Liège, , Belgium
Amsterdam, , Netherlands
Amsterdam, , Netherlands
Arnhem, , Netherlands
Santurce, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EudraCT 2008-003836-39
Identifier Type: -
Identifier Source: secondary_id
VX08-950-111
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.