Chronic Hepatitis B
Conditions
Interventions
Product Name: ABI-H0731
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: 2090064-66-5
Current Sponsor code: ABI-H0731
Other descriptive name: ABI-H0731
Concentration unit: mg milligram(
Sponsors
Assembly Biosciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide informed consent. 2. Previously enrolled on a study of ABI-H0731 and completed the treatment period, with demonstrated compliance in the opinion of the investigator. 3. Female subjects must agree to use an effective birth control method for the duration of the study and follow-up, or be surgically sterile for at least 6 months, or at least 2 years postmenopausal with serum follicle-stimulating hormone (FSH) levels consistent with a postmenopausal status. Effective birth control methods include male or female condom (may not be used together due to increased risk of breakage), vasectomy, intrauterine device (IUD), diaphragm, or cervical cap. Female subjects of childbearing potential must have a negative pregnancy test. 4. All heterosexually active male subjects must agree to use an effective birth control method for the duration of the study and follow-up. Effective birth control methods include male or female condom (may not be used together due to increased risk of breakage), vasectomy, hormone-based contraception (only female partner of a male subject), IUD, diaphragm, or cervical cap. 5. Agreement to adhere to Lifestyle Considerations (including abstaining from alcohol abuse [defined as alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol)] and the use of illicit substances, herbal or other substances, or unnecessary over-the-counter medications; see Protocol Section 5.4) throughout study duration. 6. In good general health except for chronic HBV infection. Protocol ABI-H0731-211 OLE ABI-H0731 + NUC for CHB Patients Confidential Original Version 1.1, 02 November 2018 Page 9 of 89 7. Have the ability to take oral medication and be willing to adhere to the ABIH0731-211 regimen in the opinion of the Investigator Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Must not have had evidence of RAVs or lack of compliance on a previous study of ABI-H0731. 2. Must not have had a treatment-emergent adverse event or laboratory abnormalities deemed clinically significant and possibly or probably related to drug while on a previous study of ABI-H0731, that in the opinion of the Investigator or the Sponsor makes the subject unsuitable for this study. 3. Current clinically significant cardiac or pulmonary disease, chronic or recurrent renal or urinary tract disease, liver disease other than HBV, endocrine disorder, autoimmune disorder, diabetes mellitus requiring treatment with insulin or hypoglycemic agents, neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment, or other medical conditions requiring frequent medical management or pharmacologic or surgical treatment that in the opinion of the Investigator or the Sponsor makes the subject unsuitable for the study. 4. Females who are lactating or pregnant or wish to become pregnant within the duration of the ABI-H0731-211 study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the potential for combination therapy with ABI-H0731 + SOC NUC to increase SVR rates in subjects who have CHB. SVR rates will be measured by percentage of subjects with the combination of: HBeAg loss (when applicable), loss or reduction to a stable plateau of HBsAg, and sustained loss of serum viral DNA ;Secondary Objective: To evaluate the longer-term safety and tolerability of ABI-H0731 added to SOC NUC therapy • To evaluate improvement in transaminases in subjects on treatment and post treatment • For subjects who do not achieve complete response on treatment, to evaluate the durability of changes in viral antigen and viral DNA after discontinuation of combination therapy;Primary end point(s): SVR at 24 weeks off treatment defined as: sustained HBeAg loss (in HBeAg positive subjects), sustained viral suppression, and loss or stable reduction of HBsAg to = 100 IU/mL ;Timepoint(s) of evaluation of this end point: Endpoints will be will be analyzed descriptively. For continuous variables, such as change from Baseline in mean log10 serum HBeAg or HBsAg values at each timepoint, descriptive statistics will be used and will include the number, mean, standard deviation, median, minimum, and maximum and, where appropriate, a 95% CI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Adverse events, premature discontinuations, abnormal safety laboratory results, electrocardiogram (ECG), or vital signs • Subjects with abnormal ALT at Baseline who have normal ALT at end of treatment (EOT) and end of study (EOS) • Subjects with suppression/loss of viral antigen/DNA on combination treatment whose viral antigens rebound off therapy ;Timepoint(s) of evaluation of this end point: Endpoints will be will be analyzed descriptively. For continuous variables, such as change from Baseline in mean log10 serum HBeAg or HBsAg values at each timepoint, descriptive statistics will be used and will include the number, mean, standard deviation, median, minimum, and maximum and, where appropriate, a 95% CI. | — |
Countries
Canada, Hong Kong, New Zealand, United Kingdom, United States
Contacts
Public ContactBarbara Winslow
Assembly Biosciences
Outcome results
None listed