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NCT Number: NCT07762027

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

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

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Key information

Conditions

Chronic Hepatitis D Infection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AP-HP - Beaujon Hospital, Clichy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABI-6250

Drug

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

Primary outcomes

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

    Time frame: Through study completion, an average of 1.5 years.

  2. Evaluating the change from baseline in HDV RNA & ALT levels

    Time frame: Through study completion, an average of 1.5 years.

Secondary outcomes

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

    Time frame: Through study completion, an average of 1.5 years.

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

    Time frame: Through study completion, an average of 1.5 years.

  3. In participants with abnormal baseline ALT, the proportion of participants with normal ALT

    Time frame: Through study completion, an average of 1.5 years.

  4. Change from baseline in log10 HDV RNA

    Time frame: Through study completion, an average of 1.5 years.

  5. In participants with abnormal baseline ALT, the change from baseline in ALT

    Time frame: Through study completion, an average of 1.5 years.

  6. In participants with abnormal baseline ALT, proportion of participants with normal ALT

    Time frame: Through study completion, an average of 1.5 years.

  7. To characterize the PK of ABI-6250 in plasma in participants with cHDV

    Time frame: Through study completion, an average of 1.5 years.

Sponsors and collaborators

Lead sponsor

Assembly Biosciences

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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