A Study to Assess the Safety, Pharmacokinetics, and Efficacy of ABI-6250 in Participants With Chronic Hepatitis D Virus Infection
A Phase 2, Multicenter, Open Label, Parallel-Group Study of the Safety, Pharmacokinetics, and Efficacy of ABI-6250 in Participants With Chronic Hepatitis D Virus Infection
- Registry ID
- NCT07762027
- Source registry
- NCT
- Status
- NOT_YET_RECRUITING
- Phase
- PHASE2
- Study type
- INTERVENTIONAL
- Sponsor
- Assembly Biosciences
- Enrollment
- 80
- Start date
- 2026-10-01
- Completion date
- 2028-09-01
- Last update
- 2026-08-13
Conditions
- Chronic Hepatitis D Infection
Summary
This study is designed to assess safety, pharmacokinetics, and efficacy ABI-6250 in participants with Chronic Hepatitis D Virus Infection.
Interventions
- DRUG: ABI-6250
- DRUG: ABI-6250
Inclusion criteria
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
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 outcomes
[{"measure":"Proportion of subjects with adverse events (AEs), premature treatment discontinuation and abnormal laboratory results.","timeFrame":"Through study completion, an average of 1.5 years."},{"measure":"Evaluating the change from baseline in HDV RNA \u0026 ALT levels","timeFrame":"Through study completion, an average of 1.5 years."}]
Locations
- New Zealand Clinical Research, Auckland, New Zealand
- North Manchester General Hospital, Manchester, United Kingdom
- Arensia Research Clinic, Bucharest, Romania
- Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain
- AP-HP - Beaujon Hospital, Clichy, France
- Aga Khan University Hospital, Karachi, Pakistan
- Fundeni Clinical Institute, Bucharest, Romania
- CHU Lyon - Hôpital Croix-Rousse, Lyon, France
- Medizinische Hochschule Hannover, Hanover, Germany
- Clinical Republican Hospital, Chisinau, Moldova
- Prof. Dr. Matei Bals National Institute of Infectious Diseases, Bucharest, Romania
- ARENSIA Exploratory Medicine Ivano-Frankivsk, Ivano-Frankivsk, Ukraine
- King's College Hospital London, London, United Kingdom
- Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany
- LLC Neolab, Tbilisi, Georgia
- Dr. Victor Babes Foundation, Bucharest, Romania
- Azienda Ospedaliera Universitaria, Naples, Italy
- The Royal London Hospital, London, United Kingdom
- Dr. Ziauddin Hospital, Karachi, Pakistan
- Medical Center of LLC ARENSIA Exploratory Medicine, Kyiv, Ukraine
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy
- Hôpital Henri-Mondor, Créteil, France
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