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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03109730 |
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Date of registration:
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06/04/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B
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Scientific title:
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A Phase 1b/2a, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Patients With Chronic Hepatitis B |
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Date of first enrolment:
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June 15, 2017 |
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Target sample size:
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38 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03109730 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Australia
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Hong Kong
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Korea, Republic of
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New Zealand
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Taiwan
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United Kingdom
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Hepatitis B
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Intervention(s)
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Drug: Entecavir
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Drug: Tenofovir Disoproxil Fumarate
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Drug: Placebo for ABI-H0731
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Drug: ABI-H0731
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Drug: Pegasys
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Primary Outcome(s)
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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]
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Secondary ID(s)
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ABI-H0731-101B
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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