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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03109730




Registration number
NCT03109730
Ethics application status
Date submitted
6/04/2017
Date registered
12/04/2017
Date last updated
6/07/2018

Titles & IDs
Public title
Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B
Scientific 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
Secondary ID [1] 0 0
ABI-H0731-101B
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 - ABI-H0731
Treatment: Drugs - Placebo for ABI-H0731
Treatment: Drugs - Entecavir
Treatment: Drugs - Tenofovir Disoproxil Fumarate
Treatment: Drugs - Pegasys

Experimental: Cohort B1 - ABI-H0731 or Placebo in varying doses by mouth for 28 days

Experimental: Cohort B2 - ABI-H0731 or Placebo in varying doses by mouth for 28 days

Experimental: Cohort B3 - ABI-H0731 or Placebo in varying doses by mouth for 28 days

Experimental: Cohort B4 - ABI-H0731 or Placebo in varying doses by mouth for 28 days

Experimental: Cohort B5 - ABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days

Experimental: Cohort B6 - ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days


Treatment: Drugs: ABI-H0731
A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients

Treatment: Drugs: Placebo for ABI-H0731
Sugar pill manufactured to mimic the ABI-H0731 tablet

Treatment: Drugs: Entecavir
An antiviral medication used in the treatment of hepatitis B virus infection

Treatment: Drugs: Tenofovir Disoproxil Fumarate
An antiviral medication used in the treatment of hepatitis B virus infection

Treatment: Drugs: Pegasys
Used to treat adults with chronic hepatitis B virus who show signs of liver damage
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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 receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
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
15/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/06/2018
Sample size
Target
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Monash University - Clayton
Recruitment hospital [2] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Chuncheon
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Gyeonggi-do
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Seoul
Country [5] 0 0
Taiwan
State/province [5] 0 0
Keelung
Country [6] 0 0
Taiwan
State/province [6] 0 0
Taipei
Country [7] 0 0
United Kingdom
State/province [7] 0 0
London

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03109730
Trial related presentations / publications
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/ct2/show/NCT03109730