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)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485991
|Study Director:||Tibotec Pharmaceuticals Limited Clinical Trial||Tibotec Pharmaceutical Limited|