Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B
A Phase 1b/2a, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Patients With Chronic Hepatitis B
1 other identifier
interventional
38
5 countries
14
Brief Summary
The purpose of this protocol is to obtain pharmacodynamic and pharmacokinetic data on ABI-H0731 and to provide the opportunity for preliminary evaluation of combination therapy of ABI-H0731 with currently approved antiviral treatment for chronic hepatitis B.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2017
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedStudy Start
First participant enrolled
June 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2018
CompletedJuly 6, 2018
July 1, 2018
10 months
April 6, 2017
July 3, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with chronic HBV infection with treatment-related adverse events and laboratory abnormalities as assessed by CTCAE v4.0.
Up to 57 days
Study Arms (6)
Cohort B1
EXPERIMENTALABI-H0731 or Placebo in varying doses by mouth for 28 days
Cohort B2
EXPERIMENTALABI-H0731 or Placebo in varying doses by mouth for 28 days
Cohort B3
EXPERIMENTALABI-H0731 or Placebo in varying doses by mouth for 28 days
Cohort B4
EXPERIMENTALABI-H0731 or Placebo in varying doses by mouth for 28 days
Cohort B5
EXPERIMENTALABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days
Cohort B6
EXPERIMENTALABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
Interventions
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients
Sugar pill manufactured to mimic the ABI-H0731 tablet
An antiviral medication used in the treatment of hepatitis B virus infection
An antiviral medication used in the treatment of hepatitis B virus infection
Used to treat adults with chronic hepatitis B virus who show signs of liver damage
Eligibility Criteria
You may qualify if:
- Male or female, 18 to 65 years of age
- Chronic HBV infection
- Body Mass Index (BMI) 18-38 kg/m2 and a minimum body weight of 45 kg
You may not qualify if:
- Seropositive for HIV, HCV, or HDV antibody at Screen
- Previous treatment with any investigational HBV antiviral treatments within the last 6 months
- Other known cause of liver disease, including NASH
- Other medical condition that requires persistent medical management or chronic or recurrent pharmacologic or surgical intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Monash University
Clayton, Victoria, Australia
St. Vincent's Hospital
Fitzroy, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
University of Hong Kong
Hong Kong, Hong Kong
Hallym University
Chuncheon, South Korea
CHA Bundang Medical Center
Gyeonggi-do, South Korea
Asan Medical Center
Seoul, South Korea
Severance Hospital, Yonsei University
Seoul, South Korea
Keelung Chang Gung Memorial Hospital
Keelung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
King's College Hospital
London, United Kingdom
Royal Free Hospital NHS Foundation Trust
London, United Kingdom
Royal London Hospital
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2017
First Posted
April 12, 2017
Study Start
June 15, 2017
Primary Completion
March 31, 2018
Study Completion
June 12, 2018
Last Updated
July 6, 2018
Record last verified: 2018-07