A Phase 2 interventional study of ABI-6250 and ABI-6250 in Chronic Hepatitis D Infection, sponsored by Assembly Biosciences. Not yet recruiting at 22 sites in 11 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Assembly Biosciences · Phase 2, Interventional, and Treatment
This study is designed to assess safety, pharmacokinetics, and efficacy ABI-6250 in participants with Chronic Hepatitis D Virus Infection.
43 studies on the registry are indexed under Hepatitis D, Chronic; 9 are open to participants now.
This study's planned enrollment of 80 is above the median of 46 across 30 interventional studies indexed under Hepatitis D, Chronic.
Browse Hepatitis D, Chronic studies →Assembly Biosciences is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 7 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: ABI-6250
Drug: ABI-6250
Drug: ABI-6250
Drug: ABI-6250
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.
Evaluating the change from baseline in HDV RNA & ALT levels
Time frame: Through study completion, an average of 1.5 years.
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.
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.
In participants with abnormal baseline ALT, the proportion of participants with normal ALT
Time frame: Through study completion, an average of 1.5 years.
Change from baseline in log10 HDV RNA
Time frame: Through study completion, an average of 1.5 years.
In participants with abnormal baseline ALT, the change from baseline in ALT
Time frame: Through study completion, an average of 1.5 years.
In participants with abnormal baseline ALT, proportion of participants with normal ALT
Time frame: Through study completion, an average of 1.5 years.
To characterize the PK of ABI-6250 in plasma in participants with cHDV
Time frame: Through study completion, an average of 1.5 years.
Plan to share: No
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ABI-6250