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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
Sponsor:
Information provided by (Responsible Party):
Janssen R&D Ireland

Brief Summary:
The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously failed PegIFN.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: TMC435 Drug: TVR Phase 3

Detailed Description:
This study is a randomized (study drug assigned by chance like flipping a coin), double-blind (neither physician nor patient knows the name of the assigned drug), double-dummy (patients receive both active and inactive pills also called placebo), 2-arm, multicenter Phase III clinical study in adult treatment experienced Chronic Hepatitis C (CHC) genotype-1 infected patients who failed to respond during at least 1 previous course of PegINFα-2a/ RBV therapy. The purpose of the trial is to study the efficacy of TMC435 in combination with PegINFα-2a and RBV for 48 weeks of treatment compared to the approved regimen of telaprevir in combination with PegINFα-2a and RBV for 48 weeks of treatment. The study will consist of a screening period (maximum 6 weeks), treatment period (48 weeks) and post-treatment period (until 72 weeks after the start of treatment). For the first 12 weeks one group of patients will take TMC435 and TVR placebo, plus PegINFα-2a and RBV. The other group will take TMC435 placebo and TVR, plus PegINFα-2a and RBV. After 12 weeks, patients in both arms will only take PegINFα-2a and RBV up to week 48. After patients stop taking study medication, they will continue to go to the doctor's office for study visits until a total of 72 weeks after they start study treatment. Patients will be monitored for safety throughout the study. Study assessments at each study visit may include, but are not limited to: blood and urine collection for testing, electrocardiogram (ECG) assessments (a measurement of the electrical activity of your heart), patient questionnaires, and physical examinations.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 771 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Simeprevir

Arm Intervention/treatment
Experimental: TMC435/PR Drug: TMC435
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 Drug: TVR
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must have had a liver biopsy before screening (or between the screening and baseline visit), unless patient cannot undergo such a procedure or has evidence of portal hypertension not associated with cirrhosis. For patients who had a liver biopsy performed more than 2 years prior to screening or without a biopsy (because of a contraindication or portal hypertension), a non-invasive staging assessment needs to be available. Non-invasive staging assessments include FibroScan, MR-Elastography, or FibroTest/FibroSure and must not be older than 6 months prior to screening
  • Chronicity of hepatitis C virus (HCV) infection, as confirmed by one or both of the following: presence of anti-HCV antibody and/or HCV ribonucleic acid (RNA) at least 6 months prior to the screening visit and/or presence of fibrosis on biopsy
  • Genotype 1 HCV infection with plasma HCV RNA of >10,000 IU/mL (both confirmed at screening)
  • Patient must have had at least 1 documented previous course of treatment with PegINFα-2a or PegINFα-2b in combination with ribavirin (RBV) (at least 12 weeks for null responder and 20 weeks for partial responder)

Exclusion Criteria:

  • Hepatic decompensation (impaired functioning of the liver), as indicated by significant laboratory abnormalities or other active diseases
  • Infection with Human Immunodeficiency Virus (HIV) or non genotype 1 hepatitis C
  • Liver disease not related to hepatitis C infection
  • Previous chronic hepatitis C treatment, other than PegIFN and RBV

Information from the National Library of Medicine

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


  Show 142 Study Locations
Sponsors and Collaborators
Janssen R&D Ireland
Investigators
Study Director: Tibotec Pharmaceuticals Limited Clinical Trial Tibotec Pharmaceutical Limited

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen R&D Ireland
ClinicalTrials.gov Identifier: NCT01485991     History of Changes
Other Study ID Numbers: CR100677
TMC435HPC3001 ( Other Identifier: Janssen R&D Ireland )
First Posted: December 6, 2011    Key Record Dates
Results First Posted: April 10, 2015
Last Update Posted: April 26, 2016
Last Verified: March 2016

Keywords provided by Janssen R&D Ireland:
Hepatitis C
TMC435HPC3001
TMC435
Hepatitis C Virus (HCV)
HEP C
Genotype 1
Treatment experienced
Null responders
Partial responders

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Simeprevir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors