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A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir

NCT02569710 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2019-07-16

Study results available
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Summary

The purpose of this study is to evaluate the safety and tolerability of AL-335 in combination with odalasvir (ODV) with or without simeprevir (SMV) in participants with genotype (GT)1 or GT2 or GT3 chronic hepatitis C (CHC) infection.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

AL-335

AL-335 tablets will be administered in a dose range of 400 to 1200 mg once daily (QD).

DRUG

Odalasvir (ODV)

ODV capsules will be administered in a dose range of 25 to 50 mg.

DRUG

Simeprevir (SMV)

SMV tablets will be administered in a dose range of 75 to 150 mg QD or every other day (QOD).

Sponsors & Collaborators

  • Alios Biopharma Inc.

    lead INDUSTRY

Principal Investigators

  • Alios Biopharma Inc. Clinical Trial · Alios Biopharma Inc.

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
2015-10-31
Primary Completion
2018-05-11
Completion
2018-05-11
FDA Drug
Yes

Countries

  • Mauritius
  • Moldova
  • New Zealand
  • United Kingdom

Study Locations

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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 NCT02569710 on ClinicalTrials.gov