NCT03109730

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

A Phase 1b/2a, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Patients With Chronic Hepatitis B

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Assembly Biosciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Phase 1b/2a assessments of the dose-related safety, PK, and initial antiviral efficacy of ABI-H0731 in hepatitis B patients will be conducted at approximately 17 different sites to meet enrollment goals of 108 chronic hepatitis B patients.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-06-15
• Primary completion: 2018-03-31
• Completion: 2018-06-12
• First posted: 2017-04-12
• Last updated: 2018-07-06

Locations

14 sites across 5 countries: Australia, Hong Kong, South Korea, Taiwan, United Kingdom