Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection
A Phase 2b, Multicenter, Randomized, Open-label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Different Treatment Regimens of AL-335, Odalasvir, and Simeprevir in Treatment-naive and Treatment-experienced Subjects With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5, and 6 Infection Without Cirrhosis
3 other identifiers
interventional
365
6 countries
28
Brief Summary
The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected subjects without cirrhosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2016
Shorter than P25 for phase_2
28 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
First Submitted
Initial submission to the registry
May 5, 2016
CompletedFirst Posted
Study publicly available on registry
May 6, 2016
CompletedStudy Start
First participant enrolled
November 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2017
CompletedResults Posted
Study results publicly available
January 22, 2019
CompletedNovember 20, 2019
November 1, 2019
9 months
May 5, 2016
August 6, 2018
November 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)
The SVR 12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than (\<) lower limit of quantification (LLOQ; 15 international unit per milliliter \[IU/mL\]) detectable or undetectable 12 weeks after actual EOT.
Week 12 (Follow-Up Phase)
Secondary Outcomes (5)
Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Treatment (SVR24)
Week 24 (Follow-Up Phase)
Number of Participants With Viral Relapse
End of Treatment up to Week 24 (Follow up phase)
Number of Participants With Late Viral Relapse
Up to Week 24 (Follow-up Phase)
Percentage of Participants With On-treatment Failure
EOT up to Week 12 (Follow up Phase)
Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Treatment (EOT)
Week 4 (Follow-Up Phase)
Study Arms (2)
Group A
EXPERIMENTALAL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 6 weeks.
Group B
EXPERIMENTALAL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 8 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Individuals with chronic hepatitis C virus (HCV) genotype 1, 2, 4, 5 or 6 infection
- Documented as treatment naive or experienced with a prior regimen consisting of Interferon (IFN) +/-Ribavirin (RBV) regimen without achieving sustained viral response
- Absence of cirrhosis
- Screening laboratory values within defined thresholds
- Must use specific contraceptive methods if female of childbearing potential or sexually active male
You may not qualify if:
- Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV)
- Prior exposure to an HCV direct-acting antiviral agent (DAA), either in combination with pegylated interferon (PegIFN) or IFN-free
- Current or prior history of clinical hepatic decompensation
- History of clinically significant illness or any other medical disorder including cardiovascular conditions that may interfere with individual's treatment, assessment or compliance with the protocol
- Pregnant or a nursing female
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Unknown Facility
Antwerp, Belgium
Unknown Facility
Brussels, Belgium
Unknown Facility
Edegem, Belgium
Unknown Facility
Ghent, Belgium
Unknown Facility
Kortrijik, Belgium
Unknown Facility
Leuven, Belgium
Unknown Facility
Vancouver, British Columbia, Canada
Unknown Facility
Victoria, British Columbia, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Vaughan, Ontario, Canada
Unknown Facility
Monteral, Quebec, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Berlin, Germany
Unknown Facility
Essen, Germany
Unknown Facility
Frankfurt, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Leipzig, Germany
Unknown Facility
Lodz, Poland
Unknown Facility
Lublin, Poland
Unknown Facility
Mysłowice, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Wroclaw, Poland
Unknown Facility
Singapore, Singapore
Unknown Facility
Barcelona, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Málaga, Spain
Unknown Facility
Seville, Spain
Unknown Facility
Valencia, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Physician, Medical Department
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2016
First Posted
May 6, 2016
Study Start
November 9, 2016
Primary Completion
August 9, 2017
Study Completion
November 16, 2017
Last Updated
November 20, 2019
Results First Posted
January 22, 2019
Record last verified: 2019-11