An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants
QUEST-2
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 Versus Placebo as Part of a Treatment Regimen Including Peginterferon α-2a (Pegasys®) and Ribavirin (Copegus®) or Peginterferon α-2b (PegIntron®) and Ribavirin (Rebetol®) in Treatment-naïve, Genotype 1, Hepatitis C-infected Subjects
3 other identifiers
interventional
393
15 countries
60
Brief Summary
The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2011
60 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
January 7, 2011
CompletedFirst Posted
Study publicly available on registry
February 7, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
June 13, 2014
CompletedJune 13, 2014
June 1, 2014
1.9 years
January 7, 2011
February 3, 2014
June 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)
The table below shows the percentage of participants in each treatment group who achieved a SVR12, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid 12 weeks after planned end of treatment.
Week 36 or Week 60
Secondary Outcomes (33)
The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)
Week 72
The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)
Week 48 or Week 72
The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4)
Week 28 or Week 52
Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48
Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Day 3, Week 1, Week 4, Week 12, Week 24, and Week 48
- +28 more secondary outcomes
Study Arms (2)
TMC435
EXPERIMENTALTMC435 150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a (Pegasys) or peginterferon alfa-2b (PegIntron) (PegIFN alpha-2a/b) and ribavirin (Copegus or Rebetol) for 24 or 48 weeks
Placebo
PLACEBO COMPARATORPlacebo 150 mg capsule once daily for 12 weeks in addition peginterferon alfa-2a (Pegasys) or peginterferon alfa-2b (PegIntron) (PegIFN alpha-2a/b) and ribavirin (Copegus or Rebetol) for 48 weeks
Interventions
150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 48 weeks
150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 24 or 48 weeks
One subcutaneous (under the skin) injection of PegIFNα-2a (containing 0.5 mL solution with 180 mcg PegIFNα-2a) OR PegIFNα-2b (0.5 mL from a pre-filled pen) once weekly for up to 48 weeks.
200-mg tablets of ribavirin (Copegus or Rebetol) (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.
Eligibility Criteria
You may qualify if:
- Genotype 1 hepatitis C infection (confirmed at screening)
- Participant has not received any prior treatment for hepatitis C
- Participant must have had a liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis C infection
- Must agree to use 2 forms of effective contraception throughout study (both males and females)
You may not qualify if:
- Infection with HIV or non genotype 1 hepatitis C
- Liver disease not related to hepatitic C infection
- Hepatic decompensation
- Significant laboratory abnormalities or other active diseases
- Pregnant or planning to become pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Unknown Facility
Los Angeles, California, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
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Crestview Hills, Kentucky, United States
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New Orleans, Louisiana, United States
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Saint Paul, Minnesota, United States
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Germantown, Tennessee, United States
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Houston, 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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Buenos Aires, Argentina
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Rosario, Santa Fe, Argentina
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Vienna, Austria
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Antwerp, Belgium
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Bruges, Belgium
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Brussels, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Salvador, Brazil
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São Paulo, Brazil
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Clichy, France
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Créteil, France
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Nice, France
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Paris, France
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Vandœuvre-lès-Nancy, France
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Berlin, Germany
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Düsseldorf, Germany
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Freiburg im Breisgau, Germany
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Halle, Germany
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Hanover, Germany
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Kiel, Germany
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Leipzig, Germany
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München, Germany
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Münster, Germany
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Ulm, Germany
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Amsterdam-Zuidoost, Netherlands
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Leiden, Netherlands
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Bialystok, Poland
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Bydgoszcz, Poland
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Chorzów, Poland
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Czeladź, Poland
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Kielce, Poland
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Krakow, Poland
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Warsaw, Poland
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Coimbra, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Santurce, Puerto Rico
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Bratislava, Slovakia
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Martin, Slovakia
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Barcelona, Spain
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Madrid, Spain
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Seville, Spain
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Valencia, Spain
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Ankara, Turkey (Türkiye)
Unknown Facility
Istanbul, Turkey (Türkiye)
Unknown Facility
Izmir, Turkey (Türkiye)
Related Publications (2)
Lenz O, Verbinnen T, Fevery B, Tambuyzer L, Vijgen L, Peeters M, Buelens A, Ceulemans H, Beumont M, Picchio G, De Meyer S. Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies. J Hepatol. 2015 May;62(5):1008-14. doi: 10.1016/j.jhep.2014.11.032. Epub 2014 Nov 28.
PMID: 25445400DERIVEDManns M, Marcellin P, Poordad F, de Araujo ES, Buti M, Horsmans Y, Janczewska E, Villamil F, Scott J, Peeters M, Lenz O, Ouwerkerk-Mahadevan S, De La Rosa G, Kalmeijer R, Sinha R, Beumont-Mauviel M. Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2014 Aug 2;384(9941):414-26. doi: 10.1016/S0140-6736(14)60538-9. Epub 2014 Jun 4.
PMID: 24907224DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Development Manager
- Organization
- Jan-Cil France
Study Officials
- STUDY DIRECTOR
Janssen R&D Ireland Clinical Trial
Janssen R&D Ireland
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- 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
January 7, 2011
First Posted
February 7, 2011
Study Start
March 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
June 13, 2014
Results First Posted
June 13, 2014
Record last verified: 2014-06