A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment
NCT ID: NCT00980330
Last Updated: 2014-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
463 participants
INTERVENTIONAL
2009-10-31
2011-08-31
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
QUADRUPLE
Study Groups
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TMC435 100 mg 12 Wks + PR48
Participants will receive TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
TMC435
One TMC435 100-mg capsule or two 75-mg capsules orally (by mouth) once daily for 12, 24, or 48 weeks.
Placebo
One or 2 capsules of placebo identical in appearance to TMC435 taken orally once daily for 24, 36, or 48 weeks.
Peg-IFN-alfa-2a (P)
180 micrograms taken as one 0.5 mL subcutaneous injection once weekly for 48 weeks.
Ribavirin (R)
1000 or 1200 mg/day (5 or 6 tablets) taken orally as a twice daily regimen taken for 48 weeks.
TMC435 100 mg 24 Wks + PR48
Participants willl receive TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
TMC435
One TMC435 100-mg capsule or two 75-mg capsules orally (by mouth) once daily for 12, 24, or 48 weeks.
Placebo
One or 2 capsules of placebo identical in appearance to TMC435 taken orally once daily for 24, 36, or 48 weeks.
Peg-IFN-alfa-2a (P)
180 micrograms taken as one 0.5 mL subcutaneous injection once weekly for 48 weeks.
Ribavirin (R)
1000 or 1200 mg/day (5 or 6 tablets) taken orally as a twice daily regimen taken for 48 weeks.
TMC435 100 mg 48 Wks + PR48
Participants will receive TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
TMC435
One TMC435 100-mg capsule or two 75-mg capsules orally (by mouth) once daily for 12, 24, or 48 weeks.
Placebo
One or 2 capsules of placebo identical in appearance to TMC435 taken orally once daily for 24, 36, or 48 weeks.
Peg-IFN-alfa-2a (P)
180 micrograms taken as one 0.5 mL subcutaneous injection once weekly for 48 weeks.
Ribavirin (R)
1000 or 1200 mg/day (5 or 6 tablets) taken orally as a twice daily regimen taken for 48 weeks.
TMC435 150 mg 12 Wks + PR48
Participants will receive TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
TMC435
One TMC435 100-mg capsule or two 75-mg capsules orally (by mouth) once daily for 12, 24, or 48 weeks.
Placebo
One or 2 capsules of placebo identical in appearance to TMC435 taken orally once daily for 24, 36, or 48 weeks.
Peg-IFN-alfa-2a (P)
180 micrograms taken as one 0.5 mL subcutaneous injection once weekly for 48 weeks.
Ribavirin (R)
1000 or 1200 mg/day (5 or 6 tablets) taken orally as a twice daily regimen taken for 48 weeks.
TMC435 150 mg 24 Wks + PR48
Participants will receive TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
TMC435
One TMC435 100-mg capsule or two 75-mg capsules orally (by mouth) once daily for 12, 24, or 48 weeks.
Placebo
One or 2 capsules of placebo identical in appearance to TMC435 taken orally once daily for 24, 36, or 48 weeks.
Peg-IFN-alfa-2a (P)
180 micrograms taken as one 0.5 mL subcutaneous injection once weekly for 48 weeks.
Ribavirin (R)
1000 or 1200 mg/day (5 or 6 tablets) taken orally as a twice daily regimen taken for 48 weeks.
TMC435 150 mg 48 Wks + PR48
Participants will receive TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
TMC435
One TMC435 100-mg capsule or two 75-mg capsules orally (by mouth) once daily for 12, 24, or 48 weeks.
Peg-IFN-alfa-2a (P)
180 micrograms taken as one 0.5 mL subcutaneous injection once weekly for 48 weeks.
Ribavirin (R)
1000 or 1200 mg/day (5 or 6 tablets) taken orally as a twice daily regimen taken for 48 weeks.
Placebo 48 Wks + PR48
Participants will receive Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
TMC435
One TMC435 100-mg capsule or two 75-mg capsules orally (by mouth) once daily for 12, 24, or 48 weeks.
Peg-IFN-alfa-2a (P)
180 micrograms taken as one 0.5 mL subcutaneous injection once weekly for 48 weeks.
Ribavirin (R)
1000 or 1200 mg/day (5 or 6 tablets) taken orally as a twice daily regimen taken for 48 weeks.
Interventions
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TMC435
One TMC435 100-mg capsule or two 75-mg capsules orally (by mouth) once daily for 12, 24, or 48 weeks.
Placebo
One or 2 capsules of placebo identical in appearance to TMC435 taken orally once daily for 24, 36, or 48 weeks.
Peg-IFN-alfa-2a (P)
180 micrograms taken as one 0.5 mL subcutaneous injection once weekly for 48 weeks.
Ribavirin (R)
1000 or 1200 mg/day (5 or 6 tablets) taken orally as a twice daily regimen taken for 48 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have chronic hepatitis C infection (genotype 1) with HCV RNA level greater than10000 IU/mL
* Patient must have failed at least 1 prior course of peg interferon (Peg-IFN-alfa-2a)/ribavirin (RBV) therapy (standard treatment)
* Must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication
Exclusion Criteria
* Co-infection with any other Hepatitis C virus genotype or co-infection with the human immunodeficiency virus (HIV)
* Has a medical condition which is a contraindication to Peg-INF or RBV therapy
* Have had history of, or any current medical condition which could impact the safety of the patient in the study
18 Years
70 Years
ALL
No
Sponsors
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Tibotec Pharmaceuticals, Ireland
INDUSTRY
Responsible Party
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Principal Investigators
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Tibotec Pharmaceuticals, Ireland Clinical Trial
Role: STUDY_DIRECTOR
Tibotec Pharmaceuticals, Ireland
Locations
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La Jolla, California, United States
Los Angeles, California, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Palm Harbor, Florida, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Laurel, Maryland, United States
Jackson, Mississippi, United States
Tupelo, Mississippi, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Cincinnati, Ohio, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
San Antonio, Texas, United States
Concord, , Australia
Darlinghurst, , Australia
Fitzroy, , Australia
Melbourne, , Australia
New Lambton Heights, , Australia
Parkville, , Australia
Sydney, , Australia
Woolloongabba, , Australia
Vienna, , Austria
Bruges, , Belgium
Brussels, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Roeselare, , Belgium
Calgary, Alberta, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, 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
Hanover, , Germany
Stuttgart, , Germany
Würzburg, , Germany
Haifa, , Israel
Jerusalem, , Israel
Nazareth, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Safed, , Israel
Tel Aviv, , Israel
Auckland, , New Zealand
Christchurch, , New Zealand
Hamilton, , New Zealand
Nordbyhagen, , Norway
Oslo, , Norway
Tromsø, , Norway
Bialystok, , Poland
Bydgoszcz, , Poland
Czeladź, , Poland
Kielce, , Poland
Warsaw, , Poland
Coimbra, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Moscow, , Russia
Nizhny Novgorod, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Smolensk, , Russia
London, , United Kingdom
Plymouth, , United Kingdom
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.
Scott J, Rosa K, Fu M, Cerri K, Peeters M, Beumont M, Zeuzem S, Evon DM, Gilles L. Fatigue during treatment for hepatitis C virus: results of self-reported fatigue severity in two Phase IIb studies of simeprevir treatment in patients with hepatitis C virus genotype 1 infection. BMC Infect Dis. 2014 Aug 26;14:465. doi: 10.1186/1471-2334-14-465.
Zeuzem S, Berg T, Gane E, Ferenci P, Foster GR, Fried MW, Hezode C, Hirschfield GM, Jacobson I, Nikitin I, Pockros PJ, Poordad F, Scott J, Lenz O, Peeters M, Sekar V, De Smedt G, Sinha R, Beumont-Mauviel M. Simeprevir increases rate of sustained virologic response among treatment-experienced patients with HCV genotype-1 infection: a phase IIb trial. Gastroenterology. 2014 Feb;146(2):430-41.e6. doi: 10.1053/j.gastro.2013.10.058. Epub 2013 Nov 1.
Other Identifiers
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TMC435-TiDP16-C206
Identifier Type: OTHER
Identifier Source: secondary_id
2009-010590-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR016063
Identifier Type: -
Identifier Source: org_study_id
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