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

• Status: Completed
• Trial end date: 2018-06-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assembly Biosciences
• Treatments: Entecavir; Peginterferon alfa-2a; Tenofovir

Criteria

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