A Study to Assess the Safety, Pharmacokinetics, and Efficacy of ABI-6250 in Participants With Chronic Hepatitis D Virus Infection

NCT07762027 · tracked via the Priya Life Science UK tracker

Sponsor

Assembly Biosciences

Phase

Phase 2

Started

2026-10

Last updated

2026-08-13

Condition(s) studied

Chronic Hepatitis D Infection

Investigational drug(s) / intervention(s)

ABI-6250ABI-6250

ABI-6250: Once daily tablet dosing for 48 weeks starting at Day 1 visit

ABI-6250: Once daily tablet dosing for 48 weeks, starting at Week 16 visit

Study summary

This study is designed to assess safety, pharmacokinetics, and efficacy ABI-6250 in participants with Chronic Hepatitis D Virus Infection.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: * Participant has a body mass index ≥18.0 and \<35.0 kg/m2 at Screening * Other than HBV and HDV infection, the participant is in good health (as determined by the Investigator) based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory results. * Participant agrees to comply with protocol-specified contraception requirements. Exclusion Criteria: * Participant has a current coinfection with acute hepatitis A virus (HAV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). * Participant has a history of any significant food or drug-related allergic reactions such as anaphylaxis, Stevens-Johnson syndrome, or urticaria. * Participant has been treated for HDV infection in the past 6 months prior to Day 1. * Participant took part in another clinical trial of a drug or device (other than for HDV infection) whereby the last study drug/device administration is within 30 days or 5 half-lives, whichever is longer, prior to Day 1.

Primary outcome measure(s)

Proportion of subjects with adverse events (AEs), premature treatment discontinuation and abnormal laboratory results. — Through study completion, an average of 1.5 years.
Evaluating the change from baseline in HDV RNA & ALT levels — Through study completion, an average of 1.5 years.

Trial sites (22)

Facility	City	Region
AP-HP - Beaujon Hospital	Clichy	France
Hôpital Henri-Mondor	Créteil	France
CHU Lyon - Hôpital Croix-Rousse	Lyon	France
LLC Neolab	Tbilisi	Georgia
Universitätsklinikum Hamburg-Eppendorf	Hamburg	Germany
Medizinische Hochschule Hannover	Hanover	Germany
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milan	Italy
Azienda Ospedaliera Universitaria	Naples	Italy
Clinical Republican Hospital	Chisinau	Moldova
New Zealand Clinical Research	Auckland	New Zealand
Aga Khan University Hospital	Karachi	Pakistan
Dr. Ziauddin Hospital	Karachi	Pakistan
Arensia Research Clinic	Bucharest	Romania
Dr. Victor Babes Foundation	Bucharest	Romania
Fundeni Clinical Institute	Bucharest	Romania
Prof. Dr. Matei Bals National Institute of Infectious Diseases	Bucharest	Romania
Hospital Clínico Universitario Lozano Blesa	Zaragoza	Spain
ARENSIA Exploratory Medicine Ivano-Frankivsk	Ivano-Frankivsk	Ukraine
Medical Center of LLC ARENSIA Exploratory Medicine	Kyiv	Ukraine
King's College Hospital London	London	United Kingdom
The Royal London Hospital	London	United Kingdom
North Manchester General Hospital	Manchester	United Kingdom

Other trials for the same condition

A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2) Recruiting

Study of Bulevirtide in Participants With Chronic Hepatitis D Infection Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07762027 on ClinicalTrials.gov ↗ ← All trials in the UK