Clinical Trials List
2020-10-01 - 2023-06-05
Phase II
Not yet recruiting5
ICD-10B18.1
Chronic viral hepatitis B without delta-agent
ICD-9070.32
Viral hepatitis B without mention of hepatic coma, chronic, without mention of hepatitis delta
A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection
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Trial Applicant
Syneos Health
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Sponsor
Assembly Biosciences, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Hung-Yao Chen Digestive System Department
- Tsung-Yu Tsai Digestive System Department
- Wei-Fan Hsu Digestive System Department
- Hung-Wei Wang Digestive System Department
- Hsueh-Chou Lai Digestive System Department
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Yi-Cheng Chen Digestive System Department
- Chen-Chun Lin Digestive System Department
- Chau-Ting Yeh Digestive System Department
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 楊宏志 Digestive System Department
- 洪俊銘 Digestive System Department
- 蘇東弘 Digestive System Department
- Jia-Horng Kao Digestive System Department
- PEI-JER CHEN Digestive System Department
- 曾岱宗 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Chung-Feng Huang Digestive System Department
- Jee-Fu Huang Digestive System Department
- 黃駿逸 Digestive System Department
- 梁博程 Digestive System Department
- Ming-Lung Yu Digestive System Department
- Chia-Yen Dai Digestive System Department
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Number of Participants with One or More Adverse Events [ Time Frame: Up to 96 weeks ]
Number of Participants with Premature Treatment Discontinuation due to an Adverse Event [ Time Frame: Up to 96 weeks ]
Change from Baseline in Mean log10 HBV DNA [ Time Frame: Baseline and Week 24 ]
Secondary Outcome Measures :
Trough Plasma Concentration of ABI-H2158 [ Time Frame: Predose on Day 1, Week 4, Week 48, and Week 72 ]
Trough-to-Peak Plasma Concentration Ratio of ABI-H2158 [ Time Frame: Predose on Day 1 and Weeks 4, 48, and 72 and at pre-specified intervals after dosing on Day 1 and Weeks 2, 8, 12, 16, 20, 24, and 28 ]
Trough Plasma Concentration of ETV [ Time Frame: Predose on Day 1, Week 4, Week 48, and Week 72 ]
Trough-to-Peak Plasma Concentration Ratio of ETV [ Time Frame: Predose on Day 1 and Weeks 4, 48, and 72 and at pre-specified intervals after dosing on Day 1 and Weeks 2, 8, 12, 16, 20, 24, and 28 ]
Change from Baseline in Mean log10 HBV Pre-genomic RNA (pgRNA) [ Time Frame: Baseline and Week 24 ]
Number of Participants with Reduction in HBV DNA Below the Assay Lower Limit of Quantitation [ Time Frame: Up to 96 weeks ]
Number of Participants with Reduction in HBV pgRNA Below the Assay Lower Limit of Quantitation [ Time Frame: Up to 96 weeks ]
Change from Baseline in Plasma HBV Surface Antigen (HBsAg) [ Time Frame: Baseline and up to 96 weeks ]
Change from Baseline in Plasma HBV "e" Antigen (HBeAg) [ Time Frame: Baseline and up to 96 weeks ]
Change from Baseline in Plasma HBV Core-related Antigen (HBcrAg) [ Time Frame: Baseline and up to 96 weeks ]
Number of Participants with Normal Serum Alanine Aminotransferase (ALT) [ Time Frame: Baseline and up to Week 24 ]
Number of Participants with HBV Core Protein Gene Sequence Variation Potentially Associated with Treatment Nonresponse [ Time Frame: Up to 96 weeks ]
Inclution Criteria
Body mass index of 18 - 36 kg/m^2 and body weight ≥45 kg
HBeAg ≥500 IU/mL at Screening
In good general health except for chronic HBV infection for ≥6 months documented, for example, by at least two measurements of HBsAg positivity and/or detectable HBV DNA ≥6 months apart
Lack of cirrhosis or advanced liver disease
Exclusion Criteria
Prior treatment for chronic HBV infection with lamivudine, telbivudine, adefovir, standard of care nucleoside or nucleotide analogue (NrtI), HBV core inhibitors, or an investigational agent for HBV infection
History or evidence of advanced liver disease or hepatic decompensation (including jaundice, ascites, portal hypertension, gastrointestinal bleeding, esophageal varices, hepatic encephalopathy)
History or presence of clinically significant medical conditions requiring frequent medical management or pharmacologic or surgical treatment
The Estimated Number of Participants
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Taiwan
15 participants
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Global
80 participants
