MedTrace Logo

A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects

NCT03125213 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-10-16

No results posted yet for this study

Summary

This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled study evaluating the safety, efficacy, and pharmacokinetics (PK) of AL-3778 in combination with Peg-IFN in subjects with Hepatitis B e antigen (HBeAg) positive CHB virus infection who are treatment-naïve.

The study will consist of a screening phase , a double-blind treatment phase followed by treatment with Peg-IFN alone, and a post-treatment follow-up phase.

Approximately 30 subjects to complete the study. Eligible subjects will be randomized into 2 treatment arms in a 2:1 ratio (active:placebo) to receive one of the following treatments:

* Arm A: Peg-IFN plus AL-3778 (N=20)
* Arm B: Peg-IFN plus matching placebo (N=10)

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

AL-3778

AL-3778 tablets

DRUG

Peginterferon Alfa-2A

Peginterferon Alfa-2A for subcutaneous injection

DRUG

Placebo Oral Tablet

Placebo to Match AL-3778 tablet

Sponsors & Collaborators

  • Alios Biopharma Inc.

    lead INDUSTRY

Principal Investigators

  • William Kennedy · Alios Biopharma Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-09-12
Primary Completion
2019-02-15
Completion
2019-02-15
FDA Drug
Yes

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 NCT03125213 on ClinicalTrials.gov