Status:
TERMINATED
A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients
Lead Sponsor:
Assembly Biosciences
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-71 years
Phase:
PHASE2
Brief Summary
Open-label, extension study to evaluate the safety and efficacy of combination therapy and its effect on sustained viral response biomarkers.
Detailed Description
This is an open-label extension of parent studies ABI-H0731-201 (NCT03576066) and ABI-H0731-202 (NCT03577171). The extension study will assess the safety of long-term (up to 100 weeks of treatment in ...
Eligibility Criteria
Inclusion
- Willing and able to provide informed consent.
- Previously enrolled on Study ABI-H0731-201 (NCT03576066) or ABI-H0731-202 (NCT03577171) and completed the treatment period, with demonstrated compliance in the opinion of the investigator.
- 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 serum pregnancy test.
- 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.
- 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 throughout study duration.
- In good general health except for chronic HBV infection.
- Have the ability to take oral medication and be willing to adhere to the ABI-H0731-211 regimen in the opinion of the Investigator.
Exclusion
- Must not have had evidence of HBV resistance-associated variants (RAVs) or lack of compliance on a previous study of ABI H0731.
- 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.
- 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.
- Females who are lactating or pregnant or wish to become pregnant within the duration of the ABI-H0731-211 study.
Key Trial Info
Start Date :
December 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2021
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT03780543
Start Date
December 20 2018
End Date
April 26 2021
Last Update
April 19 2023
Active Locations (24)
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1
Cedars-Sinai Medical Center
Beverly Hills, California, United States, 90211
2
Southern California Research Center
Coronado, California, United States, 92118
3
Coalition of Inclusive Medicine
Los Angeles, California, United States, 90057
4
University of California Los Angeles
Los Angeles, California, United States, 90095