3-year Follow-up Study in Patients Previously Treated With TMC435-Containing Regimen for the Treatment of Hepatitis C Virus Infection
NCT ID: NCT01349465
Last Updated: 2017-04-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
249 participants
INTERVENTIONAL
2011-07-04
2016-01-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Group 1: TMC 435 - Patients With SVR at LPVPS
Patients 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.
No treatment
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.
Group 2: TMC 435 - Patients With No SVR at LPVPS
Patients 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.
No treatment
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.
Interventions
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No treatment
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
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Inclusion Criteria
* 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
Exclusion Criteria
* Have received antiviral or immunomodulating treatment, including therapeutic vaccines, for hepatitis C virus (HCV) between LPVPS and the screening visit of present study
18 Years
ALL
No
Sponsors
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Janssen R&D Ireland
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen R&D Ireland Clinical Trial
Role: STUDY_DIRECTOR
Janssen R&D Ireland
Locations
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Bakersfield, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Saint Paul, Minnesota, United States
Tupelo, Mississippi, United States
Chapel Hill, North Carolina, United States
Cincinnati, Ohio, United States
San Antonio, Texas, United States
Antwerp, , Belgium
Bruges, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Calgary, Alberta, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, , Canada
Créteil, , France
Grenoble, , France
Lyon, , France
Nice, , France
Paris, , France
Vandœuvre-lès-Nancy, , France
Berlin, , Germany
Cologne, , Germany
Düsseldorf, , Germany
Frankfurt A. M., , Germany
Freiburg im Breisgau, , Germany
Hamburg, , Germany
Hanover, , Germany
Kiel, , Germany
Würzburg, , Germany
Bialystok, , Poland
Bydgoszcz, , Poland
Czeladź, , Poland
Mysłowice, , Poland
Warsaw, , Poland
Moscow, , Russia
Nizhny Novgorod, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Smolensk, , Russia
Stavropol, , Russia
Countries
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References
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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.
Other Identifiers
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TMC435HPC3002
Identifier Type: OTHER
Identifier Source: secondary_id
2010-019843-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR017365
Identifier Type: -
Identifier Source: org_study_id
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