A Study to Assess the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Participants
COMMIT
A Phase 2, Open-label Study to Investigate the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Subjects
3 other identifiers
interventional
106
6 countries
23
Brief Summary
The purpose of this study is to determine the efficacy of a 12- or 24-week treatment regimen of simeprevir in combination with daclatasvir, as measured by sustain virologic response 12 (SVR12), in treatment-naive, chronic hepatitis C virus (HCV) genotype 1b-infected participants who have advanced fibrosis or compensated cirrhosis (METAVIR F3/F4).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2015
Shorter than P25 for phase_2
23 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
October 15, 2014
CompletedFirst Posted
Study publicly available on registry
October 20, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
January 20, 2017
CompletedMarch 16, 2017
February 1, 2017
1 year
October 15, 2014
November 23, 2016
February 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)
Participants were considered to have reached SVR12, if 12 weeks after the actual end of treatment (EOT), hepatitis C virus (HCV) ribonucleic acid (RNA) was less than lower limit of quantification (\<LLOQ) (detectable or undetectable).
At 12 weeks after end of treatment
Secondary Outcomes (5)
Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Study Drug Treatment (SVR4)
At 4 weeks after actual EOT
Percentage of Participants With SVR 24 Weeks After End of Study Drug Treatment (SVR 24)
At 24 weeks after actual EOT
Percentage of Participants With On-treatment Failure
Up to Week 24 after actual EOT
Number of Participants With Viral Breakthrough
Up to Week 24
Number of Participants With Viral Relapse
Up to Week 24 after actual EOT
Study Arms (1)
Simeprevir + Daclatasvir
EXPERIMENTALParticipants who have Hepatitis C virus (HCV) genotype 1b infection with advanced fibrosis or compensated cirrhosis (METAVIR F3/F4) will receive simeprevir 150 milligram (mg) capsule and daclatasvir 60 mg tablet orally once daily for 12 or 24 weeks.
Interventions
Simeprevir 150 mg oral capsule will be administered once daily for 12 or 24 weeks.
Daclatasvir 60 mg oral tablet will be administered once daily for 12 or 24 weeks.
Eligibility Criteria
You may qualify if:
- Participant must have chronic Hepatitis C virus (HCV) genotype 1b infection confirmed at Screening
- Participant must have HCV ribonucleic acid (RNA) greater than (\>) 10,000 international unit per milliliter (IU/mL) at Screening
- Participant must have documented fibrosis stage at Screening (or between Screening and Day 1 \[baseline\]). Liver disease will be staged based on one of the following methods. a) Shear wave elastography (Fibroscan) within less than or equal to (\<=) 6 months before Screening or between Screening and Day 1 (baseline). METAVIR F3 \> 9.6 Kilopascals (kPa) and the cut-off for cirrhosis is greater than or equal to (\>=) 14.6 kPa. b) A biopsy documenting METAVIR F3-F4. Biopsy performed within the 24 months before Screening will be accepted for participants with METAVIR score F3. For cirrhotic participants (METAVIR score F4) a biopsy performed at any previous time is acceptable
- Participants who have cirrhosis must have an hepatic imaging procedure (ultrasound, computed tomography \[CT\] scan or magnetic resonance imaging \[MRI\]) within 6 months prior to the Screening visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma
- Participant must have a body mass index (BMI) \>= 18 Kilogram per meter\^2 (kg/m\^2)
- Participant must be treatment naive (that is, have not received prior treatment for HCV with any approved or investigational drug)
You may not qualify if:
- Participant has co-infection with HCV of another genotype; a) Participant who has HCV genotype 1b has coinfection with HCV of a genotype other than genotype 1b
- Chronic HCV genotype 1b-infected participant who has the presence of genetic variants coding for the NS5A-Y93H and/or L31M/V amino acid substitutions at Screening
- Participant has evidence of current or previous episodes of hepatic decompensation (including controlled or uncontrolled ascites, bleeding varices or hepatic encephalopathy)
- Participant has chronic liver disease of a non-HCV etiology (including but not limited to hemochromatosis, Wilson's disease, alfa 1-antitrypsin deficiency, cholangitis, drug- or alcohol-related liver disease, primary biliary cirrhosis)
- Participant has any other uncontrolled clinically significant disease or clinically significant findings during Screening that in the opinion of the investigator could compromise the participants' safety or could interfere with the participant participating in and completing the study
- Participant has coinfection with hepatitis A or hepatitis B virus (hepatitis A antibody immunoglobulin M \[IgM\] or hepatitis B surface antigen \[HBsAg\] positive at Screening)
- Participant has received a solid organ transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Unknown Facility
Antwerp, Belgium
Unknown Facility
Brussels, Belgium
Unknown Facility
Ghent, Belgium
Unknown Facility
Créteil, France
Unknown Facility
Lyon, France
Unknown Facility
Montpellier, France
Unknown Facility
Nice, France
Unknown Facility
Paris, France
Unknown Facility
Vandœuvre-lès-Nancy, France
Unknown Facility
Frankfurt, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Hanover, Germany
Unknown Facility
Kiel, Germany
Unknown Facility
Tübingen, Germany
Unknown Facility
Würzburg, Germany
Unknown Facility
Budapest, Hungary
Unknown Facility
Debrecen, Hungary
Unknown Facility
Badalona, Spain
Unknown Facility
Barcelona, Spain
Unknown Facility
Santander, Spain
Unknown Facility
Valencia, Spain
Unknown Facility
Birmingham, United Kingdom
Unknown Facility
London, United Kingdom
Related Publications (1)
Hezode C, Almasio PL, Bourgeois S, Buggisch P, Brown A, Diago M, Horsmans Y, Serfaty L, Szalay F, Gaeta GB, Planas R, Schlag M, Lonjon-Domanec I, Omoruyi E, DeMasi R, Zeuzem S. Simeprevir and daclatasvir for 12 or 24 weeks in treatment-naive patients with hepatitis C virus genotype 1b and advanced liver disease. Liver Int. 2017 Sep;37(9):1304-1313. doi: 10.1111/liv.13376. Epub 2017 Mar 13.
PMID: 28135777DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Physician
- Organization
- Janssen Research and Developement, Belgium
Study Officials
- STUDY DIRECTOR
Janssen-Cilag International NV Clinical Trial
Janssen-Cilag International NV
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2014
First Posted
October 20, 2014
Study Start
January 1, 2015
Primary Completion
January 1, 2016
Study Completion
April 1, 2016
Last Updated
March 16, 2017
Results First Posted
January 20, 2017
Record last verified: 2017-02