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
Overview
- Phase
- Phase 2
- Intervention
- AL-335
- Conditions
- Hepatitis C, Chronic
- Sponsor
- Janssen Research & Development, LLC
- Enrollment
- 365
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Detailed Description
This is a Phase 2b multicenter study. The study will include a screening period of maximum 6 weeks, a treatment period of 6 or 8 weeks and a 24-weeks post-treatment follow-up period. The total study duration for each subject will be 36 to 38 weeks. This study investigates a 3 direct-acting antiviral agent (DAA) combination of AL-335 (HCV NS5B inhibitor), odalasvir (ODV) (a second generation HCV NS5A inhibitor) and simeprevir (SMV) (HCV NS3A4 protease inhibitor). The results of this study will enable the selection of treatment and duration to be further developed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Group A
AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 6 weeks.
Intervention: AL-335
Group A
AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 6 weeks.
Intervention: Odalasvir
Group A
AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 6 weeks.
Intervention: Simeprevir
Group B
AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 8 weeks.
Intervention: AL-335
Group B
AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 8 weeks.
Intervention: Odalasvir
Group B
AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 8 weeks.
Intervention: Simeprevir
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)
Time Frame: Week 12 (Follow-Up Phase)
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.
Secondary Outcomes
- 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))