Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109730
• Other study ID #: ABI-H0731-101B
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 15, 2017
• Est. completion date: June 12, 2018

Study information

• Verified date: July 2018
• Source: Assembly Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The Phase 1b/2a assessments of the dose-related safety, PK, and initial antiviral efficacy of ABI-H0731 in hepatitis B patients will be conducted at approximately 17 different sites to meet enrollment goals of 108 chronic hepatitis B patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 12, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Australia	Monash University	Clayton	Victoria
Australia	St. Vincent's Hospital	Fitzroy	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Linear Clinical Research	Nedlands	Western Australia
Hong Kong	University of Hong Kong	Hong Kong
Korea, Republic of	Hallym University	Chuncheon
Korea, Republic of	CHA Bundang Medical Center	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Severance Hospital, Yonsei University	Seoul
Taiwan	Keelung Chang Gung Memorial Hospital	Keelung
Taiwan	National Taiwan University Hospital	Taipei
United Kingdom	King's College Hospital	London
United Kingdom	Royal Free Hospital NHS Foundation Trust	London
United Kingdom	Royal London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Assembly Biosciences

Countries where clinical trial is conducted

Australia,  Hong Kong,  Korea, Republic of,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with chronic HBV infection with treatment-related adverse events and laboratory abnormalities as assessed by CTCAE v4.0.		Up to 57 days