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Clinical Trials in Italy / NCT07762027
Starting soon Phase 2

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 Italy 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
No
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)

FacilityCityRegionStatus
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
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 Italy