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
Phase III in Partial and Null Responders
2 other identifiers
interventional
771
23 countries
129
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2012
129 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2011
CompletedFirst Posted
Study publicly available on registry
December 6, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
April 10, 2015
CompletedApril 26, 2016
March 1, 2016
2.2 years
November 25, 2011
March 27, 2015
March 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)
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.
12 Weeks After the Planned End of Treatment (EOT: Week 48)
Secondary Outcomes (2)
Percentage of Participants With Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)
24 Weeks After the Planned EOT (Week 48)
Percentage of Participants With Viral Relapse
End of Treatment (Week 48) up to Follow-up Period (until Week 72)
Study Arms (2)
TMC435/PR
EXPERIMENTALTVR/PR
ACTIVE COMPARATORInterventions
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.
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (137)
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Bakersfield, California, United States
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San Diego, California, United States
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Aurora, Colorado, United States
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Washington D.C., District of Columbia, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Crestview Hills, Kentucky, United States
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New Orleans, Louisiana, United States
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Chevy Chase, Maryland, United States
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Jackson, Mississippi, United States
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Tupelo, Mississippi, United States
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Kansas City, Missouri, United States
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Missoula, Montana, United States
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Newark, New Jersey, United States
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New York, New York, United States
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Rochester, New York, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Allentown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Arlington, Texas, United States
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Houston, Texas, United States
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Odessa, Texas, United States
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San Antonio, Texas, United States
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Falls Church, Virginia, United States
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Bellevue, Washington, United States
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Seattle, Washington, United States
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Buenos Aires, Argentina
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Rosario, Santa Fe, Argentina
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Darlinghurst, Australia
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Greenslopes, Australia
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Kingswood, Australia
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Melbourne, Australia
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Parkville - Vic, Australia
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Perth, Australia
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Sydney, Australia
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Woolloongabba, Australia
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Linz, Austria
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Vienna, Austria
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Brussels, Belgium
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Haine-Saint-Paul, La Louviere, Belgium
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Leuven, Belgium
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Liège, Belgium
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Campinas, Brazil
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Ribeirão Preto, Brazil
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Salvador, Brazil
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São Paulo, Brazil
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Sofia, Bulgaria
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Varna, Bulgaria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Brno, Czechia
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Karlovy Vary, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Copenhagen, Denmark
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Hvidovre, Denmark
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Odense, Denmark
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Grenoble, France
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Lyon, France
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Marseille, France
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Nice, France
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Paris, France
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Pessac, France
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Vandœuvre-lès-Nancy, France
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Berlin, Germany
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Frankfurt, Germany
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Freiburg im Breisgau, Germany
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Hamburg, Germany
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Hanover, Germany
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Heidelberg, Germany
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Kiel, Germany
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Mainz, Germany
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München, Germany
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Stuttgart, Germany
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Ulm, Germany
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Würzburg, Germany
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Alexandroupoli, Greece
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Athens, Greece
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Larissa, Greece
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Budapest, Hungary
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Debrecen, Hungary
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Kaposvár, Hungary
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Pécs, Hungary
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Szeged, Hungary
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Haifa, Israel
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Jerusalem, Israel
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Petah Tikva, Israel
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Ramat Gan, Israel
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Safed, Israel
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Tel Aviv, Israel
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Fredrikstad, Norway
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Nordbyhagen, Norway
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Stavanger, Norway
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Tromsø, Norway
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Bydgoszcz, Poland
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Chorzów, Poland
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Kielce, Poland
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Lodz, Poland
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Lublin, Poland
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Mysłowice, Poland
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Racibórz, Poland
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Warsaw, Poland
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Lisbon, Portugal
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Porto, Portugal
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Santurce, Puerto Rico
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Bucharest, Romania
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Constanța, Romania
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Iași, Romania
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Timișoara, Romania
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Barcelona, Spain
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Madrid, Spain
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Santander, Spain
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Seville, Spain
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Valencia, Spain
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Gothenburg, Sweden
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Lund, Sweden
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Malmo, Sweden
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Örebro, Sweden
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Stockholm, Sweden
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Lugano, Switzerland
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Sankt Gallen, Switzerland
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Zurich, Switzerland
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Glasgow, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Plymouth, United Kingdom
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Southampton, United Kingdom
Related Publications (1)
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.
PMID: 25482330DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Physician
- Organization
- Janssen IDV - Janssen Dx
Study Officials
- STUDY DIRECTOR
Tibotec Pharmaceuticals Limited Clinical Trial
Tibotec Pharmaceutical Limited
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2011
First Posted
December 6, 2011
Study Start
February 1, 2012
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
April 26, 2016
Results First Posted
April 10, 2015
Record last verified: 2016-03