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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01485991
Registration number
NCT01485991
Ethics application status
Date submitted
25/11/2011
Date registered
6/12/2011
Date last updated
26/04/2016
Titles & IDs
Public title
TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFa-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFa-2a and Ribavirin Therapy
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Scientific title
Phase III in Partial and Null Responders
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Secondary ID [1]
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TMC435HPC3001
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Secondary ID [2]
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CR100677
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Universal Trial Number (UTN)
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Trial acronym
ATTAIN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TMC435
Treatment: Drugs - TVR
Experimental: TMC435/PR -
Active Comparator: TVR/PR -
Treatment: Drugs: 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.
Treatment: Drugs: 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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)
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Assessment method [1]
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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.
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Timepoint [1]
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12 Weeks After the Planned End of Treatment (EOT: Week 48)
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Secondary outcome [1]
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Percentage of Participants With Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)
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Assessment method [1]
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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).
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Timepoint [1]
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24 Weeks After the Planned EOT (Week 48)
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Secondary outcome [2]
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Percentage of Participants With Viral Relapse
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Assessment method [2]
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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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Timepoint [2]
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End of Treatment (Week 48) up to Follow-up Period (until Week 72)
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Eligibility
Key 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
PegINFa-2a or PegINFa-2b in combination with ribavirin (RBV) (at least 12 weeks for
null responder and 20 weeks for partial responder)
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2014
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Sample size
Target
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Accrual to date
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Final
771
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Recruitment in Australia
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- Darlinghurst
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- Greenslopes
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- Kingswood
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- Darlinghurst
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- Greenslopes
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- Kingswood
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- Parkville - Vic
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Glasgow
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen R&D Ireland
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01485991
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Tibotec Pharmaceuticals Limited Clinical Trial
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01485991
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