A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection
NCT ID: NCT06384131
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2024-06-04
2025-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ABI-4334
ABI-4334
10 mg or 50 mg tablets for oral administration
Placebo
Placebo
10 mg or 50 mg tablets for oral administration
Interventions
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ABI-4334
10 mg or 50 mg tablets for oral administration
Placebo
10 mg or 50 mg tablets for oral administration
Eligibility Criteria
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Inclusion Criteria
2. Chronic hepatitis B infection, defined as HBV infection for ≥ 6 months documented
3. Treatment-naïve or off-antiviral therapy for ≥ 24 weeks prior to Screening
4. Lack of bridging fibrosis or cirrhosis
Exclusion Criteria
2. History of liver transplant or evidence of advanced liver disease, cirrhosis, or hepatic decompensation
3. Clinically significant diseases or conditions
4. History of hepatocellular carcinoma
18 Years
65 Years
ALL
No
Sponsors
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Assembly Biosciences
INDUSTRY
Responsible Party
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Locations
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ARENSIA Exploratory Medicine Chisinau
Chisinau, , Moldova
New Zealand Clinical Research
Auckland, , New Zealand
Countries
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Other Identifiers
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2024-511051-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ABI-4334-102
Identifier Type: -
Identifier Source: org_study_id
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