Health Trials

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

ConditionChronic Hepatitis D Infection
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAssembly Biosciences

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ABI-6250

    Drug

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

  • ABI-6250

    Drug

    Once daily tablet dosing for 48 weeks, starting at Week 16 visit

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Treatment Arm 1Experimental treatment 1 intervention
Group B: Treatment Arm 2Experimental treatment 1 intervention
Group C: Treatment Arm 3Experimental treatment 1 intervention
Group D: Treatment Arm 4Experimental treatment 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assembly Biosciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: