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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02908191




Registration number
NCT02908191
Ethics application status
Date submitted
14/09/2016
Date registered
20/09/2016
Date last updated
4/04/2019

Titles & IDs
Public title
A Study in Healthy Volunteers and Patients With Chronic Hepatitis B
Scientific 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
Secondary ID [1] 0 0
ABI-H0731-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Entecavir
Treatment: Drugs - Tenofovir disoproxil fumarate
Treatment: Drugs - Pegasys
Treatment: Drugs - Nucleos(t)ide

Experimental: ABI-H0731 or Matching Placebo - ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days

Experimental: 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

Experimental: 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


Treatment: Drugs: Entecavir
Used to treat adults with chronic hepatitis B virus

Treatment: Drugs: Tenofovir disoproxil fumarate
Used to treat adults with chronic hepatitis B virus

Treatment: Drugs: Pegasys
Used to treat adults with chronic hepatitis B virus who show signs of liver damage

Treatment: Drugs: Nucleos(t)ide
Used to treat adults with chronic hepatitis B virus
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.
Timepoint [1] 0 0
Up to 57 days

Eligibility
Key inclusion criteria
Healthy volunteers:

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/06/2018
Sample size
Target
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Assembly Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02908191
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02908191