NCT07762027

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
23mo left

Started Oct 2026

Geographic Reach
11 countries

22 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

August 13, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

August 5, 2026

Last Update Submit

August 7, 2026

Conditions

Chronic Hepatitis D Infection

Outcome Measures

Primary Outcomes (2)

  • 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.

Secondary Outcomes (7)

  • Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs and abnormal laboratory results.

    Through study completion, an average of 1.5 years.

  • Proportion of participants with undetectable HDV RNA or ≥2 log10 IU/mL reduction in HDV RNA

    Through study completion, an average of 1.5 years.

  • In participants with abnormal baseline ALT, the proportion of participants with normal ALT

    Through study completion, an average of 1.5 years.

  • Change from baseline in log10 HDV RNA

    Through study completion, an average of 1.5 years.

  • In participants with abnormal baseline ALT, the change from baseline in ALT

    Through study completion, an average of 1.5 years.

  • +2 more secondary outcomes

Study Arms (4)

Treatment Arm 1

EXPERIMENTAL
Drug: ABI-6250

Treatment Arm 2

EXPERIMENTAL
Drug: ABI-6250

Treatment Arm 3

EXPERIMENTAL
Drug: ABI-6250

Treatment Arm 4

EXPERIMENTAL
Drug: ABI-6250

Interventions

ABI-6250DRUG

Once daily tablet dosing for 48 weeks starting at Day 1 visit

Treatment Arm 1Treatment Arm 2Treatment Arm 4

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

AP-HP - Beaujon Hospital

Clichy, France

Location

Hôpital Henri-Mondor

Créteil, France

Location

CHU Lyon - Hôpital Croix-Rousse

Lyon, France

Location

LLC Neolab

Tbilisi, Georgia

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

Azienda Ospedaliera Universitaria

Naples, Italy

Location

Clinical Republican Hospital

Chisinau, Moldova

Location

New Zealand Clinical Research

Auckland, New Zealand

Location

Aga Khan University Hospital

Karachi, Pakistan

Location

Dr. Ziauddin Hospital

Karachi, Pakistan

Location

Arensia Research Clinic

Bucharest, Romania

Location

Dr. Victor Babes Foundation

Bucharest, Romania

Location

Fundeni Clinical Institute

Bucharest, Romania

Location

Prof. Dr. Matei Bals National Institute of Infectious Diseases

Bucharest, Romania

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Location

ARENSIA Exploratory Medicine Ivano-Frankivsk

Ivano-Frankivsk, Ukraine

Location

Medical Center of LLC ARENSIA Exploratory Medicine

Kyiv, Ukraine

Location

King's College Hospital London

London, United Kingdom

Location

The Royal London Hospital

London, United Kingdom

Location

North Manchester General Hospital

Manchester, United Kingdom

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 13, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2028

Last Updated

August 13, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)RO(4)GE(1)NZ(1)UA(2)DE(2)ES(1)FR(3)GB(3)MO(1)PA(2)