NCT02569710

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

A Phase 2a, Open-Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335 and Odalasvir, With or Without Simeprevir, in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Infection With or Without Compensated Child Pugh A Cirrhosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Alios Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2015-10-31
• Primary completion: 2018-05-11
• Completion: 2018-05-11
• First posted: 2015-10-07
• Last updated: 2019-07-16
• Results posted: 2019-07-16

Locations

11 sites across 4 countries: Mauritius, Moldova, New Zealand, United Kingdom

Regulatory

• FDA-regulated drug study