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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Phase III in Partial and Null Responders
Secondary ID [1] 0 0
TMC435HPC3001
Secondary ID [2] 0 0
CR100677
Universal Trial Number (UTN)
Trial acronym
ATTAIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)
Timepoint [1] 0 0
12 Weeks After the Planned End of Treatment (EOT: Week 48)
Secondary outcome [1] 0 0
Percentage of Participants With Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)
Timepoint [1] 0 0
24 Weeks After the Planned EOT (Week 48)
Secondary outcome [2] 0 0
Percentage of Participants With Viral Relapse
Timepoint [2] 0 0
End of Treatment (Week 48) up to Follow-up Period (until Week 72)

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)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2014
Sample size
Target
Accrual to date
Final
771
Recruitment in Australia
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- Darlinghurst
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- Greenslopes
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- Kingswood
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- Melbourne
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- Parkville - Vic
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- Perth
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- Sydney
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- Woolloongabba N/A
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- Darlinghurst
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- Greenslopes
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- Kingswood
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- Melbourne
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- Parkville - Vic
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- Perth
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- Sydney
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- Woolloongabba N/A
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen R&D Ireland
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01485991
Trial related presentations / publications
Reddy KR, Zeuzem S, Zoulim F, Weiland O, Horban A, Stanciu C, Villamil FG, Andreone P, George J, Dammers E, Fu M, Kurland D, Lenz O, Ouwerkerk-Mahadevan S, Verbinnen T, Scott J, Jessner W. Simeprevir versus telaprevir with peginterferon and ribavirin in previous null or partial responders with chronic hepatitis C virus genotype 1 infection (ATTAIN): a randomised, double-blind, non-inferiority phase 3 trial. Lancet Infect Dis. 2015 Jan;15(1):27-35. doi: 10.1016/S1473-3099(14)71002-3. Epub 2014 Dec 5. Erratum In: Lancet Infect Dis. 2016 Apr;16(4):404. doi: 10.1016/S1473-3099(16)00145-6.
Public notes

Contacts
Principal investigator
Name 0 0
Tibotec Pharmaceuticals Limited Clinical Trial
Address 0 0
Tibotec Pharmaceutical Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01485991