Chronic Hepatitis D InfectionPhase 2NCT07762027
A Study to Assess the Safety, Pharmacokinetics, and Efficacy of ABI-6250 in Participants With Chronic Hepatitis D Virus Infection
A Phase 2 study testing ABI-6250 in people with Chronic Hepatitis D Infection, run by Assembly Biosciences at 22 sites in 11 countries.
Trial summary
This study is designed to assess safety, pharmacokinetics, and efficacy ABI-6250 in participants with Chronic Hepatitis D Virus Infection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis D Infection
- What is being tested?
- ABI-6250
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 22 sitesin 11 countries
- Study dates
- Oct 2026to Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
22 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 11 countries
Romania4 sites
Arensia Research Clinic
Bucharest
Dr. Victor Babes Foundation
Bucharest
Fundeni Clinical Institute
Bucharest
Prof. Dr. Matei Bals National Institute of Infectious Diseases
Bucharest
France3 sites
AP-HP - Beaujon Hospital
Clichy
Hôpital Henri-Mondor
Créteil
CHU Lyon - Hôpital Croix-Rousse
Lyon
United Kingdom3 sites
King's College Hospital London
London
The Royal London Hospital
London
North Manchester General Hospital
Manchester
Germany2 sites
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Medizinische Hochschule Hannover
Hanover
Italy2 sites
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan
Azienda Ospedaliera Universitaria
Naples
Pakistan2 sites
Aga Khan University Hospital
Karachi
Dr. Ziauddin Hospital
Karachi
Ukraine2 sites
ARENSIA Exploratory Medicine Ivano-Frankivsk
Ivano-Frankivsk
Medical Center of LLC ARENSIA Exploratory Medicine
Kyiv
About this study
Official 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
This study is designed to assess safety, pharmacokinetics, and efficacy ABI-6250 in participants with Chronic Hepatitis D Virus Infection.
- Conditions
- Chronic Hepatitis D Infection
- Being tested
- ABI-6250
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI-6250Drug
Once daily tablet dosing for 48 weeks starting at Day 1 visit
ABI-6250Drug
Once daily tablet dosing for 48 weeks, starting at Week 16 visit
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 | Experimental | Not described Receives: Drug: ABI-6250 |
| Treatment Arm 2 | Experimental | Not described Receives: Drug: ABI-6250 |
| Treatment Arm 3 | Experimental | Not described Receives: Drug: ABI-6250 |
| Treatment Arm 4 | Experimental | Not described Receives: Drug: ABI-6250 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with adverse events (AEs), premature treatment discontinuation and abnormal laboratory results.
Measured: Through study completion, an average of 1.5 years.
Evaluating the change from baseline in HDV RNA & ALT levels
Measured: Through study completion, an average of 1.5 years.
Secondary outcomes (7)
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs and abnormal laboratory results.
Measured: 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
Measured: Through study completion, an average of 1.5 years.
In participants with abnormal baseline ALT, the proportion of participants with normal ALT
Measured: Through study completion, an average of 1.5 years.
Change from baseline in log10 HDV RNA
Measured: Through study completion, an average of 1.5 years.
In participants with abnormal baseline ALT, the change from baseline in ALT
Measured: Through study completion, an average of 1.5 years.
In participants with abnormal baseline ALT, proportion of participants with normal ALT
Measured: Through study completion, an average of 1.5 years.
To characterize the PK of ABI-6250 in plasma in participants with cHDV
Measured: Through study completion, an average of 1.5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis D InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assembly Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762027
- Sponsor's protocol ID
- ABI-6250-201
- Other IDs
- 2026-526412-36-00
- Status last verified
- Jul 2026
- First submitted
- 5 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07762027
- Acronym / sponsor ID
- ABI-6250-201
- Conditions
- Chronic Hepatitis D Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assembly BiosciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess safety, pharmacokinetics, and efficacy ABI-6250 in participants with Chronic Hepatitis D Virus Infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 | Experimental | Drug: ABI-6250 |
| Treatment Arm 2 | Experimental | Drug: ABI-6250 |
| Treatment Arm 3 | Experimental | Drug: ABI-6250 |
| Treatment Arm 4 | Experimental | Drug: ABI-6250 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABI-6250Once daily tablet dosing for 48 weeks starting at Day 1 visit | Drug | Treatment Arm 1, Treatment Arm 2, Treatment Arm 4 |
| ABI-6250Once daily tablet dosing for 48 weeks, starting at Week 16 visit | Drug | Treatment Arm 3 |
Primary outcome
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.
7 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABI-6250 in people with Chronic Hepatitis D Infection, run by Assembly Biosciences at 22 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Romania, France, United Kingdom, Germany, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.