A Study of TMC435 in Combination With Peginterferon Alfa-2A and Ribavirin for Hepatitis C Virus Genotype-1 Infected Patients Who Participated in a Control Group of a TMC435 Study
A Phase III, Open-Label, Single Arm, Rollover Trial of TMC435 in Combination With Peginterferon Alpha-2A and Ribavirin for HCV Genotype-1 Infected Subjects Who Participated in the Placebo Group of a Phase II/III TMC435 Study, or Who Received DAA Treatment in a Tibotec-Sponsored Phase I Study.
2 other identifiers
interventional
142
21 countries
71
Brief Summary
The purpose of this study is to investigate the efficacy of a treatment with TMC435 in combination with peginterferon alfa-2a and ribavirin in patients who did not clear their hepatitis C infection with peginterferon alfa-2a and ribavirin alone within a previous trial conducted by Tibotec, or who participated in Tibotec trials in which antivirals directed against hepatitis C virus (HCV) were evaluated for short periods of time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2011
Typical duration for phase_3
71 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
March 24, 2011
CompletedFirst Posted
Study publicly available on registry
March 25, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedApril 4, 2016
March 1, 2016
3.2 years
March 24, 2011
March 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of participants with sustained viral response
12 weeks after planned end of treatment
Secondary Outcomes (7)
The proportion of participants with sustained viral response
24 weeks after planned end of treatment
Number of participants with HCV RNA level >1000 IU/mL
Week 4
Number of participants with viral breakthrough
Through Week 48
Number of participants with viral relapse
Through Week 48
Number of participants with normalized alanine aminotransferase levels
Through Week 48
- +2 more secondary outcomes
Study Arms (1)
TMC435
EXPERIMENTALTMC435 Type=exact number unit=mg number=150 form=capsule route=oral use once daily for 12 weeks in addition to peginterferon alfa-2a peginterferon and ribavirin for 24 or 48 weeks
Interventions
Type=exact number, unit=mg, number=150, form=capsule, route=oral use, once daily for 12 weeks in addition to peginterferon alfa-2a peginterferon and ribavirin for 24 or 48 weeks
Eligibility Criteria
You may qualify if:
- Patients who participated in the placebo arm of a TMC435 study who did not achieve undetectable HCV RNA levels at end of treatment or who relapsed within 1 year after end of treatment OR Patients who received short-term direct-acting antiviral therapy in a Tibotec-sponsored study.
- Liver disease stage documented by liver biopsy is required within 3 years prior to screening unless contraindicated.
You may not qualify if:
- Infection with human immunodeficiency virus.
- Liver disease not related to hepatitic C infection.
- Significant laboratory abnormalities or other active diseases.
- Pregnant or planning to become pregnant.
- Prematurely stopped medication in previous TMC435 study for non-compliance or for safety reasons.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
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Bakersfield, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Englewood, Colorado, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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New Orleans, Louisiana, United States
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Jackson, Mississippi, United States
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Tupelo, Mississippi, United States
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Chapel Hill, North Carolina, United States
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Cincinnati, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Buenos Aires, Argentina
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Rosario, Santa Fe, Argentina
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Adelaide, Australia
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Concord, Australia
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Melbourne, Australia
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Wentworthville, Australia
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Woolloongabba, Australia
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Vienna, Austria
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Antwerp, Belgium
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Brussels, Belgium
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Ghent, Belgium
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São Paulo, Brazil
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Sofia, Bulgaria
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Grenoble, France
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Lyon, France
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Nice Cedex 03 N/A, France
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Paris, France
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Berlin, Germany
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Frankfurt A. M., Germany
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Hamburg, Germany
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Kiel, Germany
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Münster, Germany
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Ulm, Germany
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Würzburg, Germany
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Haifa, Israel
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Safed, Israel
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Monterrey, Mexico
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Amsterdam, Netherlands
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Rotterdam, Netherlands
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Auckland, New Zealand
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Christchurch, New Zealand
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Bydgoszcz, Poland
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Chorzów, Poland
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Czeladź, Poland
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Kielce, Poland
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Mysłowice, Poland
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Warsaw, Poland
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Coimbra, Portugal
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Lisbon, Portugal
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San Juan, Puerto Rico
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Bucharest, Romania
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Moscow, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Smolensk, Russia
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Stavropol, Russia
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Barcelona, Spain
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Madrid, Spain
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Seville, Spain
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Valencia, Spain
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Donetsk, Ukraine
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Kyiv, Ukraine
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Vinnitsa, Ukraine
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Birmingham, United Kingdom
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London, United Kingdom
Related Publications (1)
Gane EJ, DeJesus E, Janczewska E, George J, Diago M, Da Silva MH, Reesink H, Nikitin I, Hinrichsen H, Bourgeois S, Ferenci P, Shukla U, Kalmeijer R, Lenz O, Fevery B, Corbett C, Beumont M, Jessner W. Simeprevir with peginterferon alpha-2a/ribavirin for chronic hepatitis C virus genotype 1 infection in treatment-experienced patients: an open-label, rollover study. BMC Infect Dis. 2017 Jun 2;17(1):389. doi: 10.1186/s12879-017-2444-3.
PMID: 28577353DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen R&D Ireland Clinical Trial
Janssen R&D Ireland
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2011
First Posted
March 25, 2011
Study Start
December 1, 2011
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
April 4, 2016
Record last verified: 2016-03