A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment (PILLAR)
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ClinicalTrials.gov Identifier: NCT00882908 |
Recruitment Status :
Completed
First Posted : April 17, 2009
Results First Posted : June 16, 2014
Last Update Posted : June 16, 2014
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Sponsor:
Tibotec Pharmaceuticals, Ireland
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Hepatitis C |
Interventions |
Drug: TMC435 Drug: Ribavirin (R) Drug: PegIFNα-2a (P) Drug: Placebo |
Enrollment | 386 |
Participant Flow
Recruitment Details | The study was conducted at 79 sites in 13 countries: Australia, New Zealand, Canada, Austria, Belgium, Germany, Spain, France, Poland, Russia, Norway, Denmark, and the United States. Approximately 68% of participants were enrolled in Europe, 21% in North America, and 11% in Australia/New Zealand. |
Pre-assignment Details | In total, 506 participants were screened; 388 participants were randomized of whom 386 participants started treatment. Two randomized participants did not start treatment due to withdrawal of consent. |
Arm/Group Title | TMC435 75 mg 12 Wks + PR 24/48 | TMC435 75 mg 24 Wks + PR 24/48 | TMC435 150 mg 12 Wks + PR 24/48 | TMC435 150 mg 24 Wks + PR 24/48 | Placebo 24 Wks + PR48 |
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Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48. | Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48. | Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48. | Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48. | Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48. |
Period Title: Overall Study | |||||
Started | 78 | 75 | 77 | 79 | 77 |
Completed | 75 | 69 | 70 | 72 | 71 |
Not Completed | 3 | 6 | 7 | 7 | 6 |
Reason Not Completed | |||||
Adverse Event | 0 | 0 | 1 | 0 | 1 |
Lost to Follow-up | 3 | 5 | 3 | 1 | 2 |
Protocol Violation | 0 | 1 | 0 | 0 | 0 |
Withdrawal by Subject | 0 | 0 | 3 | 5 | 2 |
Subject reached a virologic endpoint | 0 | 0 | 0 | 0 | 1 |
Study terminated in error | 0 | 0 | 0 | 1 | 0 |
Baseline Characteristics
Arm/Group Title | TMC435 75 mg 12 Wks + PR 24/48 | TMC435 75 mg 24 Wks + PR 24/48 | TMC435 150 mg 12 Wks + PR 24/48 | TMC435 150 mg 24 Wks + PR 24/48 | Placebo 24 Wks + PR48 | Total | |
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Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48. | Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48. | Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48. | Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48. | Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48. | Total of all reporting groups | |
Overall Number of Baseline Participants | 78 | 75 | 77 | 79 | 77 | 386 | |
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[Not Specified]
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 78 participants | 75 participants | 77 participants | 79 participants | 77 participants | 386 participants | |
47
(19 to 66)
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46
(18 to 67)
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47
(18 to 69)
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47
(18 to 69)
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45
(21 to 67)
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46.5
(18 to 69)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 78 participants | 75 participants | 77 participants | 79 participants | 77 participants | 386 participants | |
Female |
38 48.7%
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28 37.3%
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34 44.2%
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35 44.3%
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38 49.4%
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173 44.8%
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Male |
40 51.3%
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47 62.7%
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43 55.8%
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44 55.7%
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39 50.6%
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213 55.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 78 participants | 75 participants | 77 participants | 79 participants | 77 participants | 386 participants |
Asia Pacific | 9 | 9 | 7 | 13 | 4 | 42 | |
Europe | 52 | 52 | 56 | 44 | 58 | 262 | |
North-America | 17 | 14 | 14 | 22 | 15 | 82 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Global Clinical Development Manager |
Organization: | Jan-Cil France |
EMail: | ClinicalTrialDisclosure@its.jnj.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Tibotec Pharmaceuticals, Ireland |
ClinicalTrials.gov Identifier: | NCT00882908 |
Other Study ID Numbers: |
CR015799 TMC435-TiDP16-C205 ( Other Identifier: Tibotec Pharmaceuticals, Ireland ) 2008-007147-13 ( EudraCT Number ) |
First Submitted: | April 16, 2009 |
First Posted: | April 17, 2009 |
Results First Submitted: | December 18, 2013 |
Results First Posted: | June 16, 2014 |
Last Update Posted: | June 16, 2014 |