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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04398134
Other study ID # ABI-H2158-201
Secondary ID 2019-004902-85
Status Terminated
Phase Phase 2
First received
Last updated
Start date August 28, 2020
Est. completion date December 28, 2021

Study information

Verified date August 2022
Source Assembly Biosciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This Phase 2a study will assess the safety, antiviral activity, and pharmacokinetics (PK) of ABI-H2158 administered once daily for up to 72 weeks in combination with entecavir (ETV) in participants with chronic hepatitis B virus (HBV) infection.


Recruitment information / eligibility

Status Terminated
Enrollment 88
Est. completion date December 28, 2021
Est. primary completion date October 14, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion 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

Study Design


Intervention

Drug:
ABI-H2158
3 X 100 mg tablets for oral administration
Placebo
Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV)
0.5 mg tablet for oral administration

Locations

Country Name City State
Australia Royal Prince Alfred Hospital Camperdown New South Wales
Australia St. Vincent's Hospital Darlinghurst New South Wales
Australia St. Vincent's Hospital Fitzroy Victoria
Australia Gallipoli Medical Research Foundation Greenslopes Queensland
Australia Alfred Hospital Melbourne Victoria
Australia John Hunter Hospital New Lambton New South Wales
Australia Melbourne Health Parkville Victoria
Canada Toronto Liver Centre Toronto Ontario
Canada (G.I.R.I.) GI Research Institute Vancouver British Columbia
China The First Hospital of Jilin University Changchun Jilin
China Xiangya Hospital Central South University Changsha
China The Second Affliated Hospital of Chongqing Medical University Chongqing Yuzhong District
China Guangzhou Eighth People's Hospital - Guangzhou Infectious Diseases Hospital Guangzhou
China Nanfang Hospital Guangzhou
Hong Kong Queen Mary Hospital Hong Kong
Hong Kong Prince of Wales Hospital Sha Tin New Territories
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Hallym University Chuncheon Sacred Heart Hospital Chuncheon Gangwon-do
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of SMG-SNU Boramae Medical Center Seoul
Korea, Republic of Pusan National University Yangsan Hospital Yangsan Gyeongsangnam-do
New Zealand Auckland Clinical Studies Auckland
New Zealand Waikato Hospital Hamilton
Taiwan Kaohsiung Medical University Hospital Kaohsiung City Sanmin District
Taiwan China Medical University Hospital Taichung
Taiwan Mackay Memorial Hospital Taipei Branch Taipei City
Taiwan National Taiwan University Hospital Taipei City
Taiwan Chang Gung Memorial Hospital (CGMH) - Linkou Branch Taoyuan
United Kingdom King's College Hospital London
United States Johns Hopkins University Baltimore Maryland
United States New Discovery, LLC Flushing New York
United States Coalition of Inclusive Medicine Los Angeles California
United States Northwell Health Center for Liver Disease Manhasset New York
United States University of Miami/Schiff Center for Liver Diseases Miami Florida
United States NYU Langone Health New York New York
United States California Liver Research Institute Pasadena California
United States Thomas Jefferson University Philadelphia Pennsylvania
United States Stanford University Medical Center Redwood City California
United States American Research Corporation at the Texas Liver Institute San Antonio Texas
United States Research and Education Inc. San Diego California
United States Quest Clinical Research San Francisco California
United States University of Washington Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Assembly Biosciences

Countries where clinical trial is conducted

United States,  Australia,  Canada,  China,  Hong Kong,  Korea, Republic of,  New Zealand,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Adverse Events Describes the number of participants with One or More Adverse Events while they were on treatment with the study drug. Up to 72 weeks
Primary Percentage of Participants With Premature Treatment Discontinuation Describes the number of participants who discontinued treatment with ABI-H2158/placebo prematurely. Up to 72 weeks
Primary Change From Baseline in Mean log10 HBV DNA HBV DNA was measured by Cobas AmpliPrep/ Cobas TaqMan HBV Test v2.0 (LOD 10 IU/mL). The analysis of data was descriptive only. Baseline and Week 24
Primary Percentage of Participants With Abnormal Laboratory Results Severity grades were defined by Grading Scale for Severity of Adverse Events and Laboratory Abnormalities [The DAIDS Version 2.1]. For maximum postbaseline toxicity grade, the most severe graded abnormality from all tests was counted for each participant. For each individual laboratory test, the most severe graded abnormality for that test was counted for a participant. A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last dose of ABI-H2158/Placebo plus 28 days. Up to 72 weeks
Secondary Trough Plasma Concentration of ABI-H2158 Predose on Day 1, Week 4, Week 48, and Week 72
Secondary Trough-to-Peak Plasma Concentration Ratio of ABI-H2158 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
Secondary Trough Plasma Concentration of ETV Predose on Day 1, Week 4, Week 48, and Week 72
Secondary Trough-to-Peak Plasma Concentration Ratio of ETV 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
Secondary Change in Mean log10 HBV pgRNA From Baseline to Week 24 and at Each Timepoint for ABI-H2158+ETV and PBO+ETV up to Week 72
Secondary Number of Participants With Reduction in HBV DNA Below the Assay Lower Limit of Quantitation Up to 72 weeks
Secondary Number of Participants With Reduction in HBV pgRNA Below the Assay Lower Limit of Quantitation Up to 72 weeks
Secondary Change From Baseline in Serum HBV Surface Antigen (HBsAg) Baseline and up to 72 weeks
Secondary Change From Baseline in Serum HBV "e" Antigen (HBeAg) Baseline and up to 72 weeks
Secondary Change From Baseline in Serum HBV Core-related Antigen (HBcrAg) Baseline and up to 72 weeks
Secondary Proportion of Subjects With Abnormal ALT at Baseline Who Have Normal ALT at Week 24 and at Each Timepoint on ABI-H2158+ETV and PBO+ETV Baseline and up to Week 24
Secondary Ncidence of HBV Variants With Reduced Susceptibility to ABI-H2158 Up to 72 weeks
Secondary Change in Mean log10 HBV DNA for ABI-H2158+ETV and PBO+ETV at Each Timepoint up to 72 weeks
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