TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy (ATTAIN)
|ClinicalTrials.gov Identifier: NCT01485991|
Recruitment Status : Completed
First Posted : December 6, 2011
Results First Posted : April 10, 2015
Last Update Posted : April 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Drug: TMC435 Drug: TVR||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||771 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Phase III in Partial and Null Responders|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
TMC435 Type=exact number, unit=mg, number=150, form=capsule, route=oral use. TVR placebo Form=tablet, route=oral use. TMC435 capsule is taken once daily in addition to 2 TVR placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
|Active Comparator: TVR/PR||
TVR Type=exact number, unit=mg, number=375, form=tablet, route=oral use. TMC435 placebo Form=capsule, route=oral use. 2 TVR tablets are taken 3 times a day together with 150 mg TMC435 placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks
- Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) [ Time Frame: 12 Weeks After the Planned End of Treatment (EOT: Week 48) ]Participants are considered to have reached SVR12 if both conditions below are met: 1) HCV RNA levels less than (<) 25 International unit per milliliter (IU/mL) undetectable; 2) HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable.
- Percentage of Participants With Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24) [ Time Frame: 24 Weeks After the Planned EOT (Week 48) ]Participants are considered to have reached SVR24 if both conditions below are met: 1) HCV RNA levels less than <25 International unit per milliliter (IU/mL) undetectable (at the actual end of treatment);2) HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable (24 weeks after the planned EOT).
- Percentage of Participants With Viral Relapse [ Time Frame: End of Treatment (Week 48) up to Follow-up Period (until Week 72) ]Participants are considered to have a viral relapse if both conditions as specified are met: 1) <25 IU/mL undetectable HCV RNA at the actual end of study drug treatment; 2) confirmed HCV RNA greater than or equal to (>=) 25 IU/mL during follow-up.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485991
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|Study Director:||Tibotec Pharmaceuticals Limited Clinical Trial||Tibotec Pharmaceutical Limited|