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

Janssen Research & Development, LLC365 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

365

Conditions

Hepatitis C, Chronic

Interventions

AL-335DRUG

AL-335 800 mg (2\*400) tablet will be administered once daily.

OdalasvirDRUG

Odalasvir 25 mg tablet will be administered once daily.

SimeprevirDRUG

Simeprevir 75 mg capsule will be administered once daily.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (28)

Unnamed facility

Antwerp, Belgium

Unnamed facility

Brussels, Belgium

Outcomes

Primary Outcomes

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.

Time frame: Week 12 (Follow-Up Phase)

Secondary Outcomes

Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Treatment (SVR24)

The SVR24 was defined as HCV RNA \<LLOQ (detectable or undetectable) 24 weeks after End of Treatment (EOT).

Time frame: Week 24 (Follow-Up Phase)

Number of Participants With Viral Relapse

Viral Relapse: Participants who did not achieve SVR12, with HCV RNA \<LLOQ at the EOT and confirmed HCV RNA greater than or equal to (\>=) LLOQ during follow-up.

Time frame: End of Treatment up to Week 24 (Follow up phase)

Number of Participants With Late Viral Relapse

Late Viral Relapse: Participants who achieved SVR12 but had confirmed HCV RNA\>=LLOQ afterwards during follow-up.

Time frame: Up to Week 24 (Follow-up Phase)

Percentage of Participants With On-treatment Failure

On-treatment failure: Participants who did not achieve SVR12 and with confirmed HCV RNA\>=LLOQ at the End of Treatment (EOT).

Time frame: EOT up to Week 12 (Follow up Phase)

Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Treatment (EOT)

The SVR 4 was defined as participants were considered to have reached SVR4, if 4 weeks after the actual EOT, HCV RNA was \<LLOQ (detectable or undetectable).

Data from ClinicalTrials.gov

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