Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B
- Conditions
- Chronic Hepatitis B
- Interventions
- Drug: Placebo for ABI-H0731
- Registration Number
- NCT03109730
- Lead Sponsor
- Assembly Biosciences
- 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort B5 ABI-H0731 ABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days Cohort B5 Placebo for ABI-H0731 ABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days Cohort B6 ABI-H0731 ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days Cohort B1 Placebo for ABI-H0731 ABI-H0731 or Placebo in varying doses by mouth for 28 days Cohort B2 ABI-H0731 ABI-H0731 or Placebo in varying doses by mouth for 28 days Cohort B2 Placebo for ABI-H0731 ABI-H0731 or Placebo in varying doses by mouth for 28 days Cohort B3 Placebo for ABI-H0731 ABI-H0731 or Placebo in varying doses by mouth for 28 days Cohort B6 Pegasys ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days Cohort B6 Placebo for ABI-H0731 ABI-H0731 or Placebo, in combination with a commerically-approved nucleos(t)ide plus PegIFN in treatment-experienced patients, for 28 days Cohort B4 ABI-H0731 ABI-H0731 or Placebo in varying doses by mouth for 28 days Cohort B4 Placebo for ABI-H0731 ABI-H0731 or Placebo in varying doses by mouth for 28 days Cohort B1 ABI-H0731 ABI-H0731 or Placebo in varying doses by mouth for 28 days Cohort B3 ABI-H0731 ABI-H0731 or Placebo in varying doses by mouth for 28 days Cohort B5 Entecavir ABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days Cohort B5 Tenofovir Disoproxil Fumarate ABI-H0731 or Placebo in combination with entecavir or tenofovir for 28 days
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Keelung Chang Gung Memorial Hospital
🇨🇳Keelung, Taiwan
Royal London Hospital
🇬🇧London, United Kingdom
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Hallym University
🇰🇷Chuncheon, Korea, Republic of
Linear Clinical Research
🇦🇺Nedlands, Western Australia, Australia
Severance Hospital, Yonsei University
🇰🇷Seoul, Korea, Republic of
Monash University
🇦🇺Clayton, Victoria, Australia
St. Vincent's Hospital
🇦🇺Fitzroy, Victoria, Australia
Royal Free Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
CHA Bundang Medical Center
🇰🇷Gyeonggi-do, Korea, Republic of
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
University of Hong Kong
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
King's College Hospital
🇬🇧London, United Kingdom