NCT04454567

A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors

Terminated Phase 2 Results posted Last updated 20 October 2022

What this trial tests

Phase 2 trial testing ABI-H0731 in Chronic Hepatitis B in 2 participants. Terminated before completion.

Timeline

11 November 2020

Primary endpoint
8 April 2021

8 April 2021

Quick facts

Lead sponsor	Assembly Biosciences
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	2
Start date	11 November 2020
Primary completion	8 April 2021
Estimated completion	8 April 2021
Sites	12 locations across Hong Kong, New Zealand, United States

Drugs / interventions tested

• ABI-H0731 — full drug profile →
• Placebo
• NrtI — full drug profile →

Conditions studied

• Chronic Hepatitis B — all drugs for Chronic Hepatitis B →

Sponsor

Assembly Biosciences — full company profile →

Who can join

Adults 18 to 65, any sex, with Chronic Hepatitis B. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With an Adverse Event Primary · Baseline and up to 5 months

Group	Value	95% CI
ABI-H0731 + SOC NrtI	0
Placebo + SOC NrtI	1

Number of Participants With Premature Discontinuation of Treatment Primary · Baseline and up to 5 months

Group	Value	95% CI
ABI-H0731 + SOC NrtI	1
Placebo + SOC NrtI	1

Number of Participants With a Laboratory Abnormality Primary · Baseline and up to 5 months

Group	Value	95% CI
ABI-H0731 + SOC NrtI	1
Placebo + SOC NrtI	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline and up to 5 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ABI-H0731 + SOC NrtI

Serious: 0/1 (0%)

Deaths: 0/1

Placebo + SOC NrtI

Serious: 0/1 (0%)

Deaths: 0/1

Other adverse events (2 terms — click to expand)

Reaction	System	ABI-H0731 + SOC NrtI	Placebo + SOC NrtI
COVID-19	Infections and infestations	—	—
Flu like symptoms	Injury, poisoning and procedural complications	—	—

Data from ClinicalTrials.gov NCT04454567 adverse events section.

Sponsor's own description

This study will explore the safety and antiviral activity of ABI-H0731 when added to a nucleos(t)ide reverse transcriptase inhibitor (NrtI) in participants who are partially virologically suppressed.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.