Back to resultsPhase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABI-H0731
Placebo for ABI-H0731
Entecavir
Tenofovir Disoproxil Fumarate
Pegasys
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Monash University
- St. Vincent's Hospital
- The Alfred Hospital
- Linear Clinical Research
- University of Hong Kong
- Hallym University
- CHA Bundang Medical Center
- Asan Medical Center
- Severance Hospital, Yonsei University
- Keelung Chang Gung Memorial Hospital
- National Taiwan University Hospital
- King's College Hospital
- Royal Free Hospital NHS Foundation Trust
- Royal London Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort B1
Cohort B2
Cohort B3
Cohort B4
Cohort B5
Cohort B6
Arm Description
ABI-H0731 or Placebo in varying doses by mouth for 28 days
ABI-H0731 or Placebo in varying doses by mouth for 28 days
ABI-H0731 or Placebo in varying doses by mouth for 28 days
ABI-H0731 or Placebo in varying doses by mouth for 28 days
ABI-H0731 or Placebo in combination with entecavir or tenofovir 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 patients with chronic HBV infection with treatment-related adverse events and laboratory abnormalities as assessed by CTCAE v4.0.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03109730
Brief Title
Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B
Official Title
A Phase 1b/2a, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Patients With Chronic Hepatitis B
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The Phase 1b/2a assessments of the dose-related safety, PK, and initial antiviral efficacy of ABI-H0731 in hepatitis B patients will be conducted at approximately 17 different sites to meet enrollment goals of 108 chronic hepatitis B 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, Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort B1
Arm Type
Experimental
Arm Description
ABI-H0731 or Placebo in varying doses by mouth for 28 days
Arm Title
Cohort B2
Arm Type
Experimental
Arm Description
ABI-H0731 or Placebo in varying doses by mouth for 28 days
Arm Title
Cohort B3
Arm Type
Experimental
Arm Description
ABI-H0731 or Placebo in varying doses by mouth for 28 days
Arm Title
Cohort B4
Arm Type
Experimental
Arm Description
ABI-H0731 or Placebo in varying doses by mouth for 28 days
Arm Title
Cohort B5
Arm Type
Experimental
Arm Description
ABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days
Arm Title
Cohort B6
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 Description
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients
Intervention Type
Drug
Intervention Name(s)
Placebo for ABI-H0731
Intervention Description
Sugar pill manufactured to mimic the ABI-H0731 tablet
Intervention Type
Drug
Intervention Name(s)
Entecavir
Other Intervention Name(s)
ETV
Intervention Description
An antiviral medication used in the treatment of hepatitis B virus infection
Intervention Type
Drug
Intervention Name(s)
Tenofovir Disoproxil Fumarate
Other Intervention Name(s)
TDF
Intervention Description
An antiviral medication used in the treatment of hepatitis B virus infection
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
Primary Outcome Measure Information:
Title
Number of patients with chronic HBV infection with treatment-related adverse events and laboratory abnormalities 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
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Monash University
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
St. Vincent's Hospital
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Linear Clinical Research
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
Hallym University
City
Chuncheon
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University
City
Seoul
Country
Korea, Republic of
Facility Name
Keelung Chang Gung Memorial Hospital
City
Keelung
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
King's College Hospital
City
London
Country
United Kingdom
Facility Name
Royal Free Hospital NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B
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