Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Download to PDF
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
Query!
Scientific title
Phase III in Partial and Null Responders
Query!
Secondary ID [1]
0
0
TMC435HPC3001
Query!
Secondary ID [2]
0
0
CR100677
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ATTAIN
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hepatitis C
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
12 Weeks After the Planned End of Treatment (EOT: Week 48)
Query!
Secondary outcome [1]
0
0
Percentage of Participants With Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
24 Weeks After the Planned EOT (Week 48)
Query!
Secondary outcome [2]
0
0
Percentage of Participants With Viral Relapse
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
End of Treatment (Week 48) up to Follow-up Period (until Week 72)
Query!
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)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
70
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/02/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/04/2014
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
771
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Darlinghurst
Query!
Recruitment hospital [2]
0
0
- Greenslopes
Query!
Recruitment hospital [3]
0
0
- Kingswood
Query!
Recruitment hospital [4]
0
0
- Melbourne
Query!
Recruitment hospital [5]
0
0
- Parkville - Vic
Query!
Recruitment hospital [6]
0
0
- Perth
Query!
Recruitment hospital [7]
0
0
- Sydney
Query!
Recruitment hospital [8]
0
0
- Woolloongabba N/A
Query!
Recruitment postcode(s) [1]
0
0
- Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
- Greenslopes
Query!
Recruitment postcode(s) [3]
0
0
- Kingswood
Query!
Recruitment postcode(s) [4]
0
0
- Melbourne
Query!
Recruitment postcode(s) [5]
0
0
- Parkville - Vic
Query!
Recruitment postcode(s) [6]
0
0
- Perth
Query!
Recruitment postcode(s) [7]
0
0
- Sydney
Query!
Recruitment postcode(s) [8]
0
0
- Woolloongabba N/A
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
District of Columbia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Hawaii
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kentucky
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Louisiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Maryland
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Mississippi
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Missouri
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Montana
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Jersey
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New York
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Ohio
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Pennsylvania
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Texas
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Virginia
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Washington
Query!
Country [21]
0
0
Argentina
Query!
State/province [21]
0
0
Buenos Aires N/A
Query!
Country [22]
0
0
Argentina
Query!
State/province [22]
0
0
Buenos Aires
Query!
Country [23]
0
0
Argentina
Query!
State/province [23]
0
0
Rosario, Santa Fe
Query!
Country [24]
0
0
Austria
Query!
State/province [24]
0
0
Linz
Query!
Country [25]
0
0
Austria
Query!
State/province [25]
0
0
Wien
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Brussels
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Brussel
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Haine-Saint-Paul, La Louviere
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Leuven
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Liège
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Campinas
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
Ribeirão Preto
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
Salvador
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
Sao Paulo
Query!
Country [35]
0
0
Bulgaria
Query!
State/province [35]
0
0
Sofia
Query!
Country [36]
0
0
Bulgaria
Query!
State/province [36]
0
0
Varna
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
Alberta
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
British Columbia
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Ontario
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Quebec
Query!
Country [41]
0
0
Czech Republic
Query!
State/province [41]
0
0
Brno
Query!
Country [42]
0
0
Czech Republic
Query!
State/province [42]
0
0
Karlovy Vary
Query!
Country [43]
0
0
Czech Republic
Query!
State/province [43]
0
0
Plzen
Query!
Country [44]
0
0
Czech Republic
Query!
State/province [44]
0
0
Praha 2
Query!
Country [45]
0
0
Czech Republic
Query!
State/province [45]
0
0
Praha 4
Query!
Country [46]
0
0
Denmark
Query!
State/province [46]
0
0
Copenhagen
Query!
Country [47]
0
0
Denmark
Query!
State/province [47]
0
0
Hvidovre N/A
Query!
Country [48]
0
0
Denmark
Query!
State/province [48]
0
0
Odense N/A
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Grenoble
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Lyon
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Marseille
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Nice
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Paris Cedex 12
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Paris
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Pessac
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Vandoeuvre Les Nancy
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
Berlin
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Frankfurt N/A
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Freiburg
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Hamburg
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Hannover
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Heidelberg
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Kiel
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Mainz
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
München
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Stuttgart
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Ulm
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Würzburg
Query!
Country [69]
0
0
Greece
Query!
State/province [69]
0
0
Alexandroupolis
Query!
Country [70]
0
0
Greece
Query!
State/province [70]
0
0
Athens
Query!
Country [71]
0
0
Greece
Query!
State/province [71]
0
0
Larissa
Query!
Country [72]
0
0
Hungary
Query!
State/province [72]
0
0
Budapest
Query!
Country [73]
0
0
Hungary
Query!
State/province [73]
0
0
Debrecen
Query!
Country [74]
0
0
Hungary
Query!
State/province [74]
0
0
Kaposvár
Query!
Country [75]
0
0
Hungary
Query!
State/province [75]
0
0
Pecs
Query!
Country [76]
0
0
Hungary
Query!
State/province [76]
0
0
Szeged N/A
Query!
Country [77]
0
0
Israel
Query!
State/province [77]
0
0
Haifa
Query!
Country [78]
0
0
Israel
Query!
State/province [78]
0
0
Jerusalem
Query!
Country [79]
0
0
Israel
Query!
State/province [79]
0
0
Petah Tiqva
Query!
Country [80]
0
0
Israel
Query!
State/province [80]
0
0
Ramat-Gan
Query!
Country [81]
0
0
Israel
Query!
State/province [81]
0
0
Tel-Aviv
Query!
Country [82]
0
0
Israel
Query!
State/province [82]
0
0
Zefat
Query!
Country [83]
0
0
Norway
Query!
State/province [83]
0
0
Fredrikstad
Query!
Country [84]
0
0
Norway
Query!
State/province [84]
0
0
Nordbyhagen
Query!
Country [85]
0
0
Norway
Query!
State/province [85]
0
0
Stavanger
Query!
Country [86]
0
0
Norway
Query!
State/province [86]
0
0
Tromsø
Query!
Country [87]
0
0
Poland
Query!
State/province [87]
0
0
Bydgoszcz
Query!
Country [88]
0
0
Poland
Query!
State/province [88]
0
0
Chorzow
Query!
Country [89]
0
0
Poland
Query!
State/province [89]
0
0
Kielce
Query!
Country [90]
0
0
Poland
Query!
State/province [90]
0
0
Lodz
Query!
Country [91]
0
0
Poland
Query!
State/province [91]
0
0
Lublin
Query!
Country [92]
0
0
Poland
Query!
State/province [92]
0
0
Myslowice
Query!
Country [93]
0
0
Poland
Query!
State/province [93]
0
0
Raciborz
Query!
Country [94]
0
0
Poland
Query!
State/province [94]
0
0
Warszawa
Query!
Country [95]
0
0
Portugal
Query!
State/province [95]
0
0
Lisboa
Query!
Country [96]
0
0
Portugal
Query!
State/province [96]
0
0
Lisbon
Query!
Country [97]
0
0
Portugal
Query!
State/province [97]
0
0
Porto
Query!
Country [98]
0
0
Puerto Rico
Query!
State/province [98]
0
0
Santurce
Query!
Country [99]
0
0
Romania
Query!
State/province [99]
0
0
Bucuresti
Query!
Country [100]
0
0
Romania
Query!
State/province [100]
0
0
Constanta
Query!
Country [101]
0
0
Romania
Query!
State/province [101]
0
0
Iasi
Query!
Country [102]
0
0
Romania
Query!
State/province [102]
0
0
Timisoara
Query!
Country [103]
0
0
Spain
Query!
State/province [103]
0
0
Barcelona
Query!
Country [104]
0
0
Spain
Query!
State/province [104]
0
0
Madrid
Query!
Country [105]
0
0
Spain
Query!
State/province [105]
0
0
Santander N/A
Query!
Country [106]
0
0
Spain
Query!
State/province [106]
0
0
Sevilla N/A
Query!
Country [107]
0
0
Spain
Query!
State/province [107]
0
0
Valencia
Query!
Country [108]
0
0
Sweden
Query!
State/province [108]
0
0
Göteborg
Query!
Country [109]
0
0
Sweden
Query!
State/province [109]
0
0
Lund
Query!
Country [110]
0
0
Sweden
Query!
State/province [110]
0
0
Malmö
Query!
Country [111]
0
0
Sweden
Query!
State/province [111]
0
0
Stockholm
Query!
Country [112]
0
0
Sweden
Query!
State/province [112]
0
0
Örebro
Query!
Country [113]
0
0
Switzerland
Query!
State/province [113]
0
0
Lugano
Query!
Country [114]
0
0
Switzerland
Query!
State/province [114]
0
0
St Gallen
Query!
Country [115]
0
0
Switzerland
Query!
State/province [115]
0
0
Zurich N/A
Query!
Country [116]
0
0
United Kingdom
Query!
State/province [116]
0
0
Glasgow
Query!
Country [117]
0
0
United Kingdom
Query!
State/province [117]
0
0
Leeds
Query!
Country [118]
0
0
United Kingdom
Query!
State/province [118]
0
0
London
Query!
Country [119]
0
0
United Kingdom
Query!
State/province [119]
0
0
Newcastle Upon Tyne
Query!
Country [120]
0
0
United Kingdom
Query!
State/province [120]
0
0
Plymouth
Query!
Country [121]
0
0
United Kingdom
Query!
State/province [121]
0
0
Southampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Janssen R&D Ireland
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01485991
Query!
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Tibotec Pharmaceuticals Limited Clinical Trial
Query!
Address
0
0
Tibotec Pharmaceutical Limited
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
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
Download to PDF