Back to resultsA Study in Healthy Volunteers and Patients With Chronic Hepatitis B
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Phase 1
Locations
New Zealand
Study Type
Interventional
Intervention
ABI-H0731
Placebo for ABI-H0731
Entecavir
Tenofovir disoproxil fumarate
Pegasys
Nucleos(t)ide
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B
Eligibility Criteria
Healthy volunteers:
- Male or female between 18 and 65 years old with a BMI of 18-32kg/m2
- Must be in good health and not have any health condition which could interfere with the absorption, distribution or elimination of study drug, or with the clinical and laboratory assessments in this study
CHB patients:
- Male or female between 18 and 65 years of age, with a BMI of 18-35kg/m2 and a minimum body weight of 45 kg
- Must have chronic hepatitis B with no history of clinical decompensation
- Seropositive for HIV, HCV, or HDV antibody at Screen
- Previous treatment with any HBV antiviral treatments within the last 3 months
- Other known cause of liver disease, including NASH
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
ABI-H0731 or Matching Placebo
ABI-H0731 or Placebo and ETV or TDF
ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys
Arm Description
ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days
ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days
ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
Outcomes
Primary Outcome Measures
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02908191
Brief Title
A Study in Healthy Volunteers and Patients With Chronic Hepatitis B
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
June 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assembly Biosciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABI-H0731 or Matching Placebo
Arm Type
Experimental
Arm Description
ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days
Arm Title
ABI-H0731 or Placebo and ETV or TDF
Arm Type
Experimental
Arm Description
ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days
Arm Title
ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys
Arm Type
Experimental
Arm Description
ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
Intervention Type
Drug
Intervention Name(s)
ABI-H0731
Intervention Type
Drug
Intervention Name(s)
Placebo for ABI-H0731
Other Intervention Name(s)
Sugar pill manufactured to mimic the ABI-H0731 tablet
Intervention Type
Drug
Intervention Name(s)
Entecavir
Intervention Description
Used to treat adults with chronic hepatitis B virus
Intervention Type
Drug
Intervention Name(s)
Tenofovir disoproxil fumarate
Intervention Description
Used to treat adults with chronic hepatitis B virus
Intervention Type
Drug
Intervention Name(s)
Pegasys
Other Intervention Name(s)
peginterferon alfa-2a
Intervention Description
Used to treat adults with chronic hepatitis B virus who show signs of liver damage
Intervention Type
Drug
Intervention Name(s)
Nucleos(t)ide
Intervention Description
Used to treat adults with chronic hepatitis B virus
Primary Outcome Measure Information:
Title
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.
Time Frame
Up to 57 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Healthy volunteers:
Male or female between 18 and 65 years old with a BMI of 18-32kg/m2
Must be in good health and not have any health condition which could interfere with the absorption, distribution or elimination of study drug, or with the clinical and laboratory assessments in this study
CHB patients:
Male or female between 18 and 65 years of age, with a BMI of 18-35kg/m2 and a minimum body weight of 45 kg
Must have chronic hepatitis B with no history of clinical decompensation
Seropositive for HIV, HCV, or HDV antibody at Screen
Previous treatment with any HBV antiviral treatments within the last 3 months
Other known cause of liver disease, including NASH
Facility Information:
City
Auckland
Country
New Zealand
City
Hamilton
Country
New Zealand
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31711752
Citation
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.
Results Reference
derived
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A Study in Healthy Volunteers and Patients With Chronic Hepatitis B
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