Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B
NCT ID: NCT03109730
Last Updated: 2018-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
38 participants
INTERVENTIONAL
2017-06-15
2018-06-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Cohort B1
ABI-H0731 or Placebo in varying doses by mouth for 28 days
ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients
Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet
Cohort B2
ABI-H0731 or Placebo in varying doses by mouth for 28 days
ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients
Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet
Cohort B3
ABI-H0731 or Placebo in varying doses by mouth for 28 days
ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients
Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet
Cohort B4
ABI-H0731 or Placebo in varying doses by mouth for 28 days
ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients
Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet
Cohort B5
ABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days
ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients
Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet
Entecavir
An antiviral medication used in the treatment of hepatitis B virus infection
Tenofovir Disoproxil Fumarate
An antiviral medication used in the treatment of hepatitis B virus infection
Cohort B6
ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients
Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet
Pegasys
Used to treat adults with chronic hepatitis B virus who show signs of liver damage
Interventions
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ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients
Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet
Entecavir
An antiviral medication used in the treatment of hepatitis B virus infection
Tenofovir Disoproxil Fumarate
An antiviral medication used in the treatment of hepatitis B virus infection
Pegasys
Used to treat adults with chronic hepatitis B virus who show signs of liver damage
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic HBV infection
* Body Mass Index (BMI) 18-38 kg/m2 and a minimum body weight of 45 kg
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Assembly Biosciences
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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ABI-H0731-101B
Identifier Type: -
Identifier Source: org_study_id
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