An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients
NCT ID: NCT01289782
Last Updated: 2014-06-04
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
395 participants
INTERVENTIONAL
2011-02-28
2013-01-31
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.
An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants
NCT01290679
An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy
NCT01281839
An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected Patients
NCT01725529
A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients
NCT01292239
A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment
NCT00882908
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
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TMC435
TMC435 150 mg capsule once daily for 12 weeks in addition to peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 24 or 48 weeks
TMC435
150 mg capsule once daily for 12 weeks in addition to PegIFN alpha-2a and RBV for 24 or 48 weeks
Peginterferon alpha-2a (PegIFN alpha-2a)
One subcutaneous (under the skin) injection containing 0.5 mL solution with 180 mcg PegIFN alpha-2a once weekly for up to 48 weeks.
Ribavirin (RBV)
200-mg tablets of RBV (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.
Placebo
Placebo 150 mg capsule once daily for 12 weeks in addition to PegIFNα-2a and RBV for 48 weeks
Placebo
150 mg capsule once daily for 12 weeks in addition to PegIFN alpha-2a and RBV for 48 weeks
Peginterferon alpha-2a (PegIFN alpha-2a)
One subcutaneous (under the skin) injection containing 0.5 mL solution with 180 mcg PegIFN alpha-2a once weekly for up to 48 weeks.
Ribavirin (RBV)
200-mg tablets of RBV (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
150 mg capsule once daily for 12 weeks in addition to PegIFN alpha-2a and RBV for 48 weeks
TMC435
150 mg capsule once daily for 12 weeks in addition to PegIFN alpha-2a and RBV for 24 or 48 weeks
Peginterferon alpha-2a (PegIFN alpha-2a)
One subcutaneous (under the skin) injection containing 0.5 mL solution with 180 mcg PegIFN alpha-2a once weekly for up to 48 weeks.
Ribavirin (RBV)
200-mg tablets of RBV (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 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
* Patient has not received any prior treatment for hepatitis C
* Patient must have had a liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis C infection
* Must agree to use 2 forms of effective contraception throughout study (both males and females)
Exclusion Criteria
* Liver disease not related to hepatitic C infection
* Hepatic decompensation
* Significant laboratory abnormalities or other active diseases
* Pregnant or planning to become pregnant
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen R&D Ireland
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.
Janssen R&D Ireland Clinical Trial
Role: STUDY_DIRECTOR
Janssen R&D Ireland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dothan, Alabama, United States
Hoover, Alabama, United States
Phoenix, Arizona, United States
Bakersfield, California, United States
Coronado, California, United States
Long Beach, California, United States
San Diego, California, United States
Aurora, Colorado, United States
Englewood, Colorado, United States
Miami, Florida, United States
Chicago, Illinois, United States
Jackson, Mississippi, United States
Tupelo, Mississippi, United States
St Louis, Missouri, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Darlinghurst, , Australia
Fitzroy, , Australia
Kingswood, , Australia
Melbourne, , Australia
Sydney, , Australia
Wolloongabba, , Australia
Calgary, Alberta, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Berlin, , Germany
Heidelberg, , Germany
Kiel, , Germany
Tübingen, , Germany
Guadalajara, , Mexico
Mex Ctity, , Mexico
Monterrey, , Mexico
Auckland, , New Zealand
Christchurch, , New Zealand
Hamilton, , New Zealand
San Juan, , Puerto Rico
Bucharest, , Romania
Moscow, , Russia
Nizhny Novgorod, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Smolensk, , Russia
Barcelona, , Spain
Madrid, , Spain
Seville, , Spain
Valencia, , Spain
Donetsk, , Ukraine
Kiev, , Ukraine
Kyiv, , Ukraine
Vinnytsia, , Ukraine
Derby, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Nottingham, , United Kingdom
Plymouth, , United Kingdom
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.
Lenz O, Verbinnen T, Fevery B, Tambuyzer L, Vijgen L, Peeters M, Buelens A, Ceulemans H, Beumont M, Picchio G, De Meyer S. Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies. J Hepatol. 2015 May;62(5):1008-14. doi: 10.1016/j.jhep.2014.11.032. Epub 2014 Nov 28.
Jacobson IM, Dore GJ, Foster GR, Fried MW, Radu M, Rafalsky VV, Moroz L, Craxi A, Peeters M, Lenz O, Ouwerkerk-Mahadevan S, De La Rosa G, Kalmeijer R, Scott J, Sinha R, Beumont-Mauviel M. Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-1): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2014 Aug 2;384(9941):403-13. doi: 10.1016/S0140-6736(14)60494-3. Epub 2014 Jun 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TMC435-TiDP16-C208
Identifier Type: OTHER
Identifier Source: secondary_id
CR017386
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.