A Study to Assess the Effectiveness, Safety, and Pharmacokinetics of TMC435 in Combination With Peginterferon Alfa-2a and Ribavirin in Hepatitis-C Infected Patients
NCT ID: NCT00996476
Last Updated: 2014-04-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
92 participants
INTERVENTIONAL
2009-07-31
2011-01-31
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
NONE
Study Groups
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TMC12/PR24 50 mg
Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels \<1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
TMC435
One 50 or 100-mg capsule orally (by mouth), once daily for 12 or 24 weeks
PegIFNα-2a
One subcutaneous injection of PegIFNα-2a 180 μg once weekly for 12, 24, or 48 weeks.
RBV
300, 400, or 500-mg tablets orally twice daily for 12, 24, or 48 weeks.
TMC12/PR24 100 mg
Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels \<1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
TMC435
One 50 or 100-mg capsule orally (by mouth), once daily for 12 or 24 weeks
PegIFNα-2a
One subcutaneous injection of PegIFNα-2a 180 μg once weekly for 12, 24, or 48 weeks.
RBV
300, 400, or 500-mg tablets orally twice daily for 12, 24, or 48 weeks.
TMC24/PR24 50 mg
Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels \<1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
TMC435
One 50 or 100-mg capsule orally (by mouth), once daily for 12 or 24 weeks
PegIFNα-2a
One subcutaneous injection of PegIFNα-2a 180 μg once weekly for 12, 24, or 48 weeks.
RBV
300, 400, or 500-mg tablets orally twice daily for 12, 24, or 48 weeks.
TMC24/PR24 100 mg
Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels \<1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
TMC435
One 50 or 100-mg capsule orally (by mouth), once daily for 12 or 24 weeks
PegIFNα-2a
One subcutaneous injection of PegIFNα-2a 180 μg once weekly for 12, 24, or 48 weeks.
RBV
300, 400, or 500-mg tablets orally twice daily for 12, 24, or 48 weeks.
PR48 Control
Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)
TMC435
One 50 or 100-mg capsule orally (by mouth), once daily for 12 or 24 weeks
PegIFNα-2a
One subcutaneous injection of PegIFNα-2a 180 μg once weekly for 12, 24, or 48 weeks.
RBV
300, 400, or 500-mg tablets orally twice daily for 12, 24, or 48 weeks.
Interventions
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TMC435
One 50 or 100-mg capsule orally (by mouth), once daily for 12 or 24 weeks
PegIFNα-2a
One subcutaneous injection of PegIFNα-2a 180 μg once weekly for 12, 24, or 48 weeks.
RBV
300, 400, or 500-mg tablets orally twice daily for 12, 24, or 48 weeks.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
70 Years
ALL
No
Sponsors
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Janssen Pharmaceutical K.K.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Pharmaceutical K.K. Clinical Trial
Role: STUDY_DIRECTOR
Janssen Pharmaceutical K.K.
Locations
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Amagasaki, , Japan
Hiroshima, , Japan
Kagoshima, , Japan
Kawasaki, , Japan
Kitakyushu, , Japan
Kurume, , Japan
Kyoto, , Japan
Matsumoto, , Japan
Musashino, , Japan
Nishinomiya, , Japan
Ohmura, , Japan
Osaka, , Japan
Ōsaka-sayama, , Japan
Sakai, , Japan
Sapporo, , Japan
Suita, , Japan
Tokyo, , Japan
Touon, , Japan
Yokohama, , Japan
Countries
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References
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Hayashi N, Seto C, Kato M, Komada Y, Goto S. Once-daily simeprevir (TMC435) with peginterferon/ribavirin for treatment-naive hepatitis C genotype 1-infected patients in Japan: the DRAGON study. J Gastroenterol. 2014 Jan;49(1):138-47. doi: 10.1007/s00535-013-0875-1. Epub 2013 Sep 5.
Other Identifiers
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TMC435-TiDP16-C215
Identifier Type: OTHER
Identifier Source: secondary_id
CR016402
Identifier Type: -
Identifier Source: org_study_id
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