MedTrace Logo

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

NCT02765490 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2019-11-20

Study results available
· View outcomes & findings →

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.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

AL-335

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

DRUG

Odalasvir

Odalasvir 25 mg tablet will be administered once daily.

DRUG

Simeprevir

Simeprevir 75 mg capsule will be administered once daily.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-09
Primary Completion
2017-08-09
Completion
2017-11-16

Countries

  • Belgium
  • Canada
  • Germany
  • Poland
  • Singapore
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02765490 on ClinicalTrials.gov