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

Assembly Biosciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: Tenofovir Disoproxil Fumarate; Drug: Pegasys; Drug: Entecavir; Drug: ABI-H0731; Drug: Placebo for ABI-H0731

Study type: Interventional

Funder types: Industry

Identifiers

NCT03109730

ABI-H0731-101B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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38 participants in 6 patient groups

Cohort B1

Experimental group

Description:

ABI-H0731 or Placebo in varying doses by mouth for 28 days

Treatment:

Drug: ABI-H0731

Drug: Placebo for ABI-H0731

Cohort B2

Experimental group

Description:

ABI-H0731 or Placebo in varying doses by mouth for 28 days

Treatment:

Drug: ABI-H0731

Drug: Placebo for ABI-H0731

Cohort B3

Experimental group

Description:

ABI-H0731 or Placebo in varying doses by mouth for 28 days

Treatment:

Drug: ABI-H0731

Drug: Placebo for ABI-H0731

Cohort B4

Experimental group

Description:

ABI-H0731 or Placebo in varying doses by mouth for 28 days

Treatment:

Drug: ABI-H0731

Drug: Placebo for ABI-H0731

Cohort B5

Experimental group

Description:

ABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days

Treatment:

Drug: ABI-H0731

Drug: Placebo for ABI-H0731

Drug: Entecavir

Drug: Tenofovir Disoproxil Fumarate

Cohort B6

Experimental group

Description:

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

Treatment:

Drug: ABI-H0731

Drug: Placebo for ABI-H0731

Drug: Pegasys