Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: Odalasvir; Drug: AL-335; Drug: Simeprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02765490

2015-004200-38 (EudraCT Number)

64294178HPC2001 (Other Identifier)

CR108070

Details and patient eligibility

About

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.

Full 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.

Enrollment: 365 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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365 participants in 2 patient groups

Group A

Experimental group

Description:

AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 6 weeks.

Treatment:

Drug: Simeprevir

Drug: Odalasvir

Drug: AL-335

Group B

Experimental group

Description:

AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 8 weeks.

Treatment:

Drug: Simeprevir

Drug: Odalasvir

Drug: AL-335