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Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B

NCT03109730 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2018-07-06

No results posted yet for this study

Summary

The purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on ABI-H0731 and to provide the opportunity for preliminary evaluation of combination therapy of ABI-H0731 with currently approved antiviral treatment for chronic hepatitis B.

Conditions

Interventions

DRUG

ABI-H0731

A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients

DRUG

Placebo for ABI-H0731

Sugar pill manufactured to mimic the ABI-H0731 tablet

DRUG

Entecavir

An antiviral medication used in the treatment of hepatitis B virus infection

DRUG

Tenofovir Disoproxil Fumarate

An antiviral medication used in the treatment of hepatitis B virus infection

DRUG

Pegasys

Used to treat adults with chronic hepatitis B virus who show signs of liver damage

Sponsors & Collaborators

  • Assembly Biosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2017-06-15
Primary Completion
2018-03-31
Completion
2018-06-12

Countries

  • Australia
  • Hong Kong
  • South Korea
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT03109730 on ClinicalTrials.gov