Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Recruitment state(s)
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- Greenslopes
Recruitment hospital [3] 0 0
- Kingswood
Recruitment hospital [4] 0 0
- Melbourne
Recruitment hospital [5] 0 0
- Parkville - Vic
Recruitment hospital [6] 0 0
- Perth
Recruitment hospital [7] 0 0
- Sydney
Recruitment hospital [8] 0 0
- Woolloongabba N/A
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Greenslopes
Recruitment postcode(s) [3] 0 0
- Kingswood
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Parkville - Vic
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment postcode(s) [7] 0 0
- Sydney
Recruitment postcode(s) [8] 0 0
- Woolloongabba N/A
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Hawaii
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Montana
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires N/A
Country [22] 0 0
Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Argentina
State/province [23] 0 0
Rosario, Santa Fe
Country [24] 0 0
Austria
State/province [24] 0 0
Linz
Country [25] 0 0
Austria
State/province [25] 0 0
Wien
Country [26] 0 0
Belgium
State/province [26] 0 0
Brussels
Country [27] 0 0
Belgium
State/province [27] 0 0
Brussel
Country [28] 0 0
Belgium
State/province [28] 0 0
Haine-Saint-Paul, La Louviere
Country [29] 0 0
Belgium
State/province [29] 0 0
Leuven
Country [30] 0 0
Belgium
State/province [30] 0 0
Liège
Country [31] 0 0
Brazil
State/province [31] 0 0
Campinas
Country [32] 0 0
Brazil
State/province [32] 0 0
Ribeirão Preto
Country [33] 0 0
Brazil
State/province [33] 0 0
Salvador
Country [34] 0 0
Brazil
State/province [34] 0 0
Sao Paulo
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Sofia
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Varna
Country [37] 0 0
Canada
State/province [37] 0 0
Alberta
Country [38] 0 0
Canada
State/province [38] 0 0
British Columbia
Country [39] 0 0
Canada
State/province [39] 0 0
Ontario
Country [40] 0 0
Canada
State/province [40] 0 0
Quebec
Country [41] 0 0
Czech Republic
State/province [41] 0 0
Brno
Country [42] 0 0
Czech Republic
State/province [42] 0 0
Karlovy Vary
Country [43] 0 0
Czech Republic
State/province [43] 0 0
Plzen
Country [44] 0 0
Czech Republic
State/province [44] 0 0
Praha 2
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Praha 4
Country [46] 0 0
Denmark
State/province [46] 0 0
Copenhagen
Country [47] 0 0
Denmark
State/province [47] 0 0
Hvidovre N/A
Country [48] 0 0
Denmark
State/province [48] 0 0
Odense N/A
Country [49] 0 0
France
State/province [49] 0 0
Grenoble
Country [50] 0 0
France
State/province [50] 0 0
Lyon
Country [51] 0 0
France
State/province [51] 0 0
Marseille
Country [52] 0 0
France
State/province [52] 0 0
Nice
Country [53] 0 0
France
State/province [53] 0 0
Paris Cedex 12
Country [54] 0 0
France
State/province [54] 0 0
Paris
Country [55] 0 0
France
State/province [55] 0 0
Pessac
Country [56] 0 0
France
State/province [56] 0 0
Vandoeuvre Les Nancy
Country [57] 0 0
Germany
State/province [57] 0 0
Berlin
Country [58] 0 0
Germany
State/province [58] 0 0
Frankfurt N/A
Country [59] 0 0
Germany
State/province [59] 0 0
Freiburg
Country [60] 0 0
Germany
State/province [60] 0 0
Hamburg
Country [61] 0 0
Germany
State/province [61] 0 0
Hannover
Country [62] 0 0
Germany
State/province [62] 0 0
Heidelberg
Country [63] 0 0
Germany
State/province [63] 0 0
Kiel
Country [64] 0 0
Germany
State/province [64] 0 0
Mainz
Country [65] 0 0
Germany
State/province [65] 0 0
München
Country [66] 0 0
Germany
State/province [66] 0 0
Stuttgart
Country [67] 0 0
Germany
State/province [67] 0 0
Ulm
Country [68] 0 0
Germany
State/province [68] 0 0
Würzburg
Country [69] 0 0
Greece
State/province [69] 0 0
Alexandroupolis
Country [70] 0 0
Greece
State/province [70] 0 0
Athens
Country [71] 0 0
Greece
State/province [71] 0 0
Larissa
Country [72] 0 0
Hungary
State/province [72] 0 0
Budapest
Country [73] 0 0
Hungary
State/province [73] 0 0
Debrecen
Country [74] 0 0
Hungary
State/province [74] 0 0
Kaposvár
Country [75] 0 0
Hungary
State/province [75] 0 0
Pecs
Country [76] 0 0
Hungary
State/province [76] 0 0
Szeged N/A
Country [77] 0 0
Israel
State/province [77] 0 0
Haifa
Country [78] 0 0
Israel
State/province [78] 0 0
Jerusalem
Country [79] 0 0
Israel
State/province [79] 0 0
Petah Tiqva
Country [80] 0 0
Israel
State/province [80] 0 0
Ramat-Gan
Country [81] 0 0
Israel
State/province [81] 0 0
Tel-Aviv
Country [82] 0 0
Israel
State/province [82] 0 0
Zefat
Country [83] 0 0
Norway
State/province [83] 0 0
Fredrikstad
Country [84] 0 0
Norway
State/province [84] 0 0
Nordbyhagen
Country [85] 0 0
Norway
State/province [85] 0 0
Stavanger
Country [86] 0 0
Norway
State/province [86] 0 0
Tromsø
Country [87] 0 0
Poland
State/province [87] 0 0
Bydgoszcz
Country [88] 0 0
Poland
State/province [88] 0 0
Chorzow
Country [89] 0 0
Poland
State/province [89] 0 0
Kielce
Country [90] 0 0
Poland
State/province [90] 0 0
Lodz
Country [91] 0 0
Poland
State/province [91] 0 0
Lublin
Country [92] 0 0
Poland
State/province [92] 0 0
Myslowice
Country [93] 0 0
Poland
State/province [93] 0 0
Raciborz
Country [94] 0 0
Poland
State/province [94] 0 0
Warszawa
Country [95] 0 0
Portugal
State/province [95] 0 0
Lisboa
Country [96] 0 0
Portugal
State/province [96] 0 0
Lisbon
Country [97] 0 0
Portugal
State/province [97] 0 0
Porto
Country [98] 0 0
Puerto Rico
State/province [98] 0 0
Santurce
Country [99] 0 0
Romania
State/province [99] 0 0
Bucuresti
Country [100] 0 0
Romania
State/province [100] 0 0
Constanta
Country [101] 0 0
Romania
State/province [101] 0 0
Iasi
Country [102] 0 0
Romania
State/province [102] 0 0
Timisoara
Country [103] 0 0
Spain
State/province [103] 0 0
Barcelona
Country [104] 0 0
Spain
State/province [104] 0 0
Madrid
Country [105] 0 0
Spain
State/province [105] 0 0
Santander N/A
Country [106] 0 0
Spain
State/province [106] 0 0
Sevilla N/A
Country [107] 0 0
Spain
State/province [107] 0 0
Valencia
Country [108] 0 0
Sweden
State/province [108] 0 0
Göteborg
Country [109] 0 0
Sweden
State/province [109] 0 0
Lund
Country [110] 0 0
Sweden
State/province [110] 0 0
Malmö
Country [111] 0 0
Sweden
State/province [111] 0 0
Stockholm
Country [112] 0 0
Sweden
State/province [112] 0 0
Örebro
Country [113] 0 0
Switzerland
State/province [113] 0 0
Lugano
Country [114] 0 0
Switzerland
State/province [114] 0 0
St Gallen
Country [115] 0 0
Switzerland
State/province [115] 0 0
Zurich N/A
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Glasgow
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Leeds
Country [118] 0 0
United Kingdom
State/province [118] 0 0
London
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Newcastle Upon Tyne
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Plymouth
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen R&D Ireland
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01485991