Chronic Hepatitis D Infection
Conditions
Brief summary
This study is designed to assess safety, pharmacokinetics, and efficacy ABI-6250 in participants with Chronic Hepatitis D Virus Infection.
Interventions
DRUGABI-6250
Once daily tablet dosing for 48 weeks starting at Day 1 visit
Sponsors
Assembly Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. |
| In participants with abnormal baseline ALT, proportion of participants with normal ALT | Through study completion, an average of 1.5 years. |
| To characterize the PK of ABI-6250 in plasma in participants with cHDV | Through study completion, an average of 1.5 years. |
Countries
France, Georgia, Germany, Italy, Moldova, New Zealand, Pakistan, Romania, Spain, Ukraine, United Kingdom
Outcome results
None listed