Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of a 12- or 8-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve and -Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection Without Cirrhosis
2 other identifiers
interventional
310
2 countries
40
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12 weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus (HCV) genotype 1 infected men and women without cirrhosis who are HCV treatment-naïve or treatment-experienced.
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 Apr 2014
Shorter than P25 for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 2, 2014
CompletedFirst Posted
Study publicly available on registry
April 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
April 12, 2016
CompletedApril 12, 2016
March 1, 2016
9 months
April 2, 2014
January 19, 2016
March 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)
Participants considered to have achieved SVR12, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (\<) lower limit of quantification (LLOQ; 25 international unit per milliliter \[IU/mL\]) detectable or undetectable at 12 weeks after the actual end of study drug treatment.
12 weeks after the end of treatment (EOT) (Week 20 or Week 24)
Secondary Outcomes (9)
Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)
4 weeks after the end of treatment (EOT) (Week 12 or Week 16)
Percentage of Participants Achieving a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)
24 weeks after the end of treatment (EOT) (Week 32 or Week 36)
Percentage of Participants Achieving a On-treatment Virologic Response
Day 14, Day 28, End of treatment (Week 8 or Week 12)
Percentage of Participants With Viral Breakthrough
Up to Week 24
Percentage of Participants With Viral Relapse
Up to Week 24
- +4 more secondary outcomes
Study Arms (2)
Arm 1 (Simeprevir/Sofosbuvir)
EXPERIMENTAL150 participants will receive 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
Arm 2 (Simeprevir/Sofosbuvir)
EXPERIMENTAL150 participants will receive 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally once daily for 8 weeks.
Interventions
150 participants will receive 1 capsule of 150 mg simeprevir orally once daily for 12 weeks in Arm 1.
150 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks in Arm 1.
Eligibility Criteria
You may qualify if:
- Hepatitis C virus (HCV) genotype 1a or 1b infection confirmed before randomization
- Documentation of the presence or absence of a NS3 Q80K polymorphism in HCV genotype 1a infected participants before randomization
- Documentation of the IL28B genotype before randomization
- HCV ribonucleic acid level greater than 10,000 IU/mL at screening
- Treatment-experienced participants must have at least 1 documented previous course of interferon-based regimen with or without ribavirin
- Absence of cirrhosis in participants
You may not qualify if:
- Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy)
- Infection/co-infection with HCV non-genotype 1a or 1b
- Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening)
- Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen positive)
- Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Unknown Facility
Dothan, Alabama, United States
Unknown Facility
Bakersfield, California, United States
Unknown Facility
Chula Vista, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
San Diego, California, United States
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Englewood, Colorado, United States
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Bradenton, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
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Lauderdale Lakes, Florida, United States
Unknown Facility
Maitland, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Wellington, Florida, United States
Unknown Facility
Zephyrhills, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Columbus, Georgia, United States
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Marietta, Georgia, United States
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Indianapolis, Indiana, United States
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Jackson, Mississippi, United States
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Kansas City, Missouri, United States
Unknown Facility
Hillsborough, New Jersey, United States
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Vineland, New Jersey, United States
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Manhasset, New York, United States
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New York, New York, United States
Unknown Facility
Asheville, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
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East Greenwich, Rhode Island, United States
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Providence, Rhode Island, United States
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Greer, South Carolina, United States
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Germantown, Tennessee, United States
Unknown Facility
Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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San Antonio, Texas, United States
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Falls Church, Virginia, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Vancouver, British Columbia, Canada
Unknown Facility
Montreal, Quebec, Canada
Related Publications (1)
Kwo P, Gitlin N, Nahass R, Bernstein D, Etzkorn K, Rojter S, Schiff E, Davis M, Ruane P, Younes Z, Kalmeijer R, Sinha R, Peeters M, Lenz O, Fevery B, De La Rosa G, Scott J, Witek J. Simeprevir plus sofosbuvir (12 and 8 weeks) in hepatitis C virus genotype 1-infected patients without cirrhosis: OPTIMIST-1, a phase 3, randomized study. Hepatology. 2016 Aug;64(2):370-80. doi: 10.1002/hep.28467. Epub 2016 Mar 22.
PMID: 26799692DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Associate Director Clinical Research
- Organization
- Janssen Infectious Diseases BVBA
Study Officials
- STUDY DIRECTOR
Janssen Infectious Diseases BVBA Clinical Trial
Janssen Infectious Diseases BVBA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2014
First Posted
April 15, 2014
Study Start
April 1, 2014
Primary Completion
January 1, 2015
Study Completion
April 1, 2015
Last Updated
April 12, 2016
Results First Posted
April 12, 2016
Record last verified: 2016-03