An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants
NCT ID: NCT01290679
Last Updated: 2014-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
393 participants
INTERVENTIONAL
2011-03-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TMC435
TMC435 150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a (Pegasys) or peginterferon alfa-2b (PegIntron) (PegIFN alpha-2a/b) and ribavirin (Copegus or Rebetol) for 24 or 48 weeks
TMC435
150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 24 or 48 weeks
Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b)
One subcutaneous (under the skin) injection of PegIFNα-2a (containing 0.5 mL solution with 180 mcg PegIFNα-2a) OR PegIFNα-2b (0.5 mL from a pre-filled pen) once weekly for up to 48 weeks.
Ribavirin (RBV)
200-mg tablets of ribavirin (Copegus or Rebetol) (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 peginterferon alfa-2a (Pegasys) or peginterferon alfa-2b (PegIntron) (PegIFN alpha-2a/b) and ribavirin (Copegus or Rebetol) for 48 weeks
Placebo
150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 48 weeks
Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b)
One subcutaneous (under the skin) injection of PegIFNα-2a (containing 0.5 mL solution with 180 mcg PegIFNα-2a) OR PegIFNα-2b (0.5 mL from a pre-filled pen) once weekly for up to 48 weeks.
Ribavirin (RBV)
200-mg tablets of ribavirin (Copegus or Rebetol) (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.
Interventions
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Placebo
150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 48 weeks
TMC435
150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 24 or 48 weeks
Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b)
One subcutaneous (under the skin) injection of PegIFNα-2a (containing 0.5 mL solution with 180 mcg PegIFNα-2a) OR PegIFNα-2b (0.5 mL from a pre-filled pen) once weekly for up to 48 weeks.
Ribavirin (RBV)
200-mg tablets of ribavirin (Copegus or Rebetol) (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant has not received any prior treatment for hepatitis C
* Participant 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
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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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Los Angeles, California, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Crestview Hills, Kentucky, United States
New Orleans, Louisiana, United States
Saint Paul, Minnesota, United States
Germantown, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Falls Church, Virginia, United States
Buenos Aires, , Argentina
Rosario, Santa Fe, , Argentina
Vienna, , Austria
Antwerp, , Belgium
Bruges, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Salvador, , Brazil
São Paulo, , Brazil
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Clichy, , France
Créteil, , France
Nice, , France
Paris, , France
Vandœuvre-lès-Nancy, , France
Berlin, , Germany
Düsseldorf, , Germany
Freiburg im Breisgau, , Germany
Halle, , Germany
Hanover, , Germany
Kiel, , Germany
Leipzig, , Germany
München, , Germany
Münster, , Germany
Ulm, , Germany
Amsterdam-Zuidoost, , Netherlands
Leiden, , Netherlands
Bialystok, , Poland
Bydgoszcz, , Poland
Chorzów, , Poland
Czeladź, , Poland
Kielce, , Poland
Krakow, , Poland
Warsaw, , Poland
Coimbra, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Santurce, , Puerto Rico
Bratislava, , Slovakia
Martin, , Slovakia
Barcelona, , Spain
Madrid, , Spain
Seville, , Spain
Valencia, , Spain
Ankara, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Countries
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References
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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.
Manns M, Marcellin P, Poordad F, de Araujo ES, Buti M, Horsmans Y, Janczewska E, Villamil F, Scott J, Peeters M, Lenz O, Ouwerkerk-Mahadevan S, De La Rosa G, Kalmeijer R, Sinha R, Beumont-Mauviel M. Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2014 Aug 2;384(9941):414-26. doi: 10.1016/S0140-6736(14)60538-9. Epub 2014 Jun 4.
Other Identifiers
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TMC435-TiDP16-C216
Identifier Type: OTHER
Identifier Source: secondary_id
2010-021174-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR017380
Identifier Type: -
Identifier Source: org_study_id
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