A Study in Healthy Volunteers and Patients With Chronic Hepatitis B
NCT ID: NCT02908191
Last Updated: 2019-04-04
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
86 participants
INTERVENTIONAL
2016-11-30
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
PARALLEL
TREATMENT
SINGLE
Study Groups
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ABI-H0731 or Matching Placebo
ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days
ABI-H0731
Placebo for ABI-H0731
ABI-H0731 or Placebo and ETV or TDF
ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days
ABI-H0731
Placebo for ABI-H0731
Entecavir
Used to treat adults with chronic hepatitis B virus
Tenofovir disoproxil fumarate
Used to treat adults with chronic hepatitis B virus
ABI-H0731 or Placebo and a Nucleos(t)ide and Pegasys
ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days
ABI-H0731
Placebo for ABI-H0731
Pegasys
Used to treat adults with chronic hepatitis B virus who show signs of liver damage
Nucleos(t)ide
Used to treat adults with chronic hepatitis B virus
Interventions
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ABI-H0731
Placebo for ABI-H0731
Entecavir
Used to treat adults with chronic hepatitis B virus
Tenofovir disoproxil fumarate
Used to treat adults with chronic hepatitis B virus
Pegasys
Used to treat adults with chronic hepatitis B virus who show signs of liver damage
Nucleos(t)ide
Used to treat adults with chronic hepatitis B virus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Male or female between 18 and 65 years old with a BMI of 18-32kg/m2
2. 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:
1. 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
2. Must have chronic hepatitis B with no history of clinical decompensation
3. Seropositive for HIV, HCV, or HDV antibody at Screen
4. Previous treatment with any HBV antiviral treatments within the last 3 months
5. Other known cause of liver disease, including NASH
18 Years
65 Years
ALL
Yes
Sponsors
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Assembly Biosciences
INDUSTRY
Responsible Party
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Locations
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Auckland, , New Zealand
Hamilton, , New Zealand
Countries
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References
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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.
Other Identifiers
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ABI-H0731-101
Identifier Type: -
Identifier Source: org_study_id
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