3-year Follow-up Study in Patients Previously Treated With TMC435-Containing Regimen for the Treatment of Hepatitis C Virus Infection
A Prospective 3-Year Follow-up Study in Subjects Previously Treated in a Phase IIb or Phase III Study With a TMC435-Containing Regimen for the Treatment of Hepatitis C Virus (HCV) Infection
3 other identifiers
interventional
249
7 countries
48
Brief Summary
The purpose of this study is to investigate durability of SVR in chronic HCV patients who achieved SVR in the previous study with TMC435-containing regimen and time for resistance associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in the previous study with TMC435-containing regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2011
Longer than P75 for phase_3
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2011
CompletedFirst Posted
Study publicly available on registry
May 6, 2011
CompletedStudy Start
First participant enrolled
July 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2016
CompletedResults Posted
Study results publicly available
February 16, 2017
CompletedApril 10, 2017
March 1, 2017
4.5 years
April 26, 2011
December 23, 2016
March 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percentage of Participants Maintaining SVR at the Last Available Visit
The SVR rate is the proportion (%) of participants with HCV RNA less than (\<) 25 International Units/milliliter (IU/mL).
Last Available Visit (Month 36 for subjects completing the study)
Overall Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study
Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.
Baseline and Month 36
Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study
Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.
Baseline and Month 36
Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study
Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.
Baseline and Month 36
Secondary Outcomes (2)
Percentage of Participants With Late Viral Relapse
End of study (at month 36)
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
End of study (at month 36)
Study Arms (2)
Group 1: TMC 435 - Patients With SVR at LPVPS
OTHERPatients with sustained virologic response (SVR) who completed last post-therapy follow-up visit of the previous study (LPVPS) \[Phase IIb or Phase III\] in which they received a TMC435-containing regimen for the treatment of HCV infection.
Group 2: TMC 435 - Patients With No SVR at LPVPS
OTHERPatients with no sustained virologic response (SVR) who completed last post-therapy follow-up visit of the previous study (LPVPS) \[Phase IIb or Phase III\] in which they received a TMC435-containing regimen for the treatment of HCV infection.
Interventions
No treatment was given to patients during this study as this is a follow-up study of previous Phase IIb or Phase III in which they received a TMC435-containing regimen.
Eligibility Criteria
You may qualify if:
- Have previously participated in a Phase IIb or Phase III study
- Must have received at least one dose of TMC435 in that study
- Has completed the last post-therapy follow-up visit of the previous (LPVPS) study
You may not qualify if:
- Must be currently enrolled or plan to enroll in another study with an investigational drug or invasive investigational medical device
- Have received antiviral or immunomodulating treatment, including therapeutic vaccines, for hepatitis C virus (HCV) between LPVPS and the screening visit of present study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Unknown Facility
Bakersfield, California, United States
Unknown Facility
La Jolla, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Orlando, Florida, United States
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Chicago, Illinois, United States
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New Orleans, Louisiana, United States
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Saint Paul, Minnesota, 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
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Antwerp, Belgium
Unknown Facility
Bruges, Belgium
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Brussels, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Calgary, Alberta, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Canada
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Créteil, France
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Grenoble, France
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Lyon, France
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Nice, France
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Paris, France
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Vandœuvre-lès-Nancy, France
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Berlin, Germany
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Cologne, Germany
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Düsseldorf, Germany
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Frankfurt A. M., Germany
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Freiburg im Breisgau, Germany
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Hamburg, Germany
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Hanover, Germany
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Kiel, Germany
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Würzburg, Germany
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Bialystok, Poland
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Bydgoszcz, Poland
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Czeladź, Poland
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Mysłowice, Poland
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Warsaw, Poland
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Moscow, Russia
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Nizhny Novgorod, Russia
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Saint Petersburg, Russia
Unknown Facility
Samara, Russia
Unknown Facility
Smolensk, Russia
Unknown Facility
Stavropol, Russia
Related Publications (1)
Zoulim F, Moreno C, Lee SS, Buggisch P, Horban A, Lawitz E, Corbett C, Lenz O, Fevery B, Verbinnen T, Shukla U, Jessner W. A 3-year follow-up study after treatment with simeprevir in combination with pegylated interferon-alpha and ribavirin for chronic hepatitis C virus infection. Virol J. 2018 Jan 30;15(1):26. doi: 10.1186/s12985-018-0936-4.
PMID: 29378602DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Responsible Scientist
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen R&D Ireland Clinical Trial
Janssen R&D Ireland
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2011
First Posted
May 6, 2011
Study Start
July 4, 2011
Primary Completion
January 5, 2016
Study Completion
January 5, 2016
Last Updated
April 10, 2017
Results First Posted
February 16, 2017
Record last verified: 2017-03