A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B
NCT ID: NCT03714152
Last Updated: 2021-01-27
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
80 participants
INTERVENTIONAL
2018-11-13
2021-01-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults
NCT04271592
A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults
NCT04083716
A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection
NCT04398134
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection
NCT05414981
A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors
NCT04454567
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ABI-H2158
ABI-H2158 in varying doses of tablets by mouth without and with food for 1 day or 10 days
ABI-H2158
5 mg or 25 mg tablets
Matching Placebo for ABI-H2158
Matching Placebo in varying doses of tablets by mouth without and with food for 1 day or 10 days
Placebo for ABI-H2158
Sugar pill manufactured to mimic the ABI-H2158 5 mg or 25 mg tablets
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ABI-H2158
5 mg or 25 mg tablets
Placebo for ABI-H2158
Sugar pill manufactured to mimic the ABI-H2158 5 mg or 25 mg tablets
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. In good general health except for chronic HBV infection, documented by:
1. Clinical history, physical exam and routine laboratory measurements without major or clinically significant findings
2. Serologic profile consistent with chronic HBV infection • HBeAg-positive at Screening with HBV viral load ≥ 2× 105 IU/mL
3. Liver evaluation demonstrating the absence of bridging fibrosis or cirrhosis
Exclusion Criteria
2. History or presence of any other clinically significant current medical conditions requiring ongoing pharmacological treatment.
3. Previous treatment with any investigational HBV antiviral treatments within the last 6 months, or previous treatment at any time with an investigational HBV antiviral treatment of the same class (core protein targeted therapies).
4. Previous treatment with a commercially approved HBV therapy within the last 6 months
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assembly Biosciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Southern California Research Center
Coronado, California, United States
Research and Education
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
Infectious Disease Care
Hillsborough, New Jersey, United States
Monash University
Clayton, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
First Hospital of Jilin University
Jilin, Changchun, China
University of Hong Kong, Queen Mary Hospital
Hong Kong, , Hong Kong
Auckland Clinical Studies
Auckland, , New Zealand
Hallym University
Chuncheon, , South Korea
Asan Medical Center
Seoul, , South Korea
Severance Hospital, Yonsei University
Seoul, , South Korea
King's College London
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ABI-H2158-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.