A Study in Healthy Volunteers and Patients With Chronic Hepatitis B
A Phase 1a/1b, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Healthy Volunteers and Patients With Chronic Hepatitis B
1 other identifier
interventional
86
1 country
2
Brief Summary
This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging assessment of ABI-H0731 in non-cirrhotic, CHB patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2016
2 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
September 14, 2016
CompletedFirst Posted
Study publicly available on registry
September 20, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
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
CompletedApril 4, 2019
April 1, 2019
1.4 years
September 14, 2016
April 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.
Up to 57 days
Study Arms (3)
ABI-H0731 or Matching Placebo
EXPERIMENTALABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days
ABI-H0731 or Placebo and ETV or TDF
EXPERIMENTALABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days
ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys
EXPERIMENTALABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
Interventions
Used to treat adults with chronic hepatitis B virus
Used to treat adults with chronic hepatitis B virus who show signs of liver damage
Used to treat adults with chronic hepatitis B virus
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Auckland, New Zealand
Unknown Facility
Hamilton, New Zealand
Related Publications (1)
Yuen MF, Agarwal K, Gane EJ, Schwabe C, Ahn SH, Kim DJ, Lim YS, Cheng W, Sievert W, Visvanathan K, Ruby E, Liaw S, Yan R, Huang Q, Colonno R, Lopatin U. Safety, pharmacokinetics, and antiviral effects of ABI-H0731, a hepatitis B virus core inhibitor: a randomised, placebo-controlled phase 1 trial. Lancet Gastroenterol Hepatol. 2020 Feb;5(2):152-166. doi: 10.1016/S2468-1253(19)30346-2. Epub 2019 Nov 9.
PMID: 31711752DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2016
First Posted
September 20, 2016
Study Start
November 1, 2016
Primary Completion
March 31, 2018
Study Completion
June 12, 2018
Last Updated
April 4, 2019
Record last verified: 2019-04