A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients

Stopped early · Phase 2

Conditions studied: Chronic Hepatitis B

In brief

Open-label, extension study to evaluate the safety and efficacy of combination therapy and its effect on sustained viral response biomarkers.

Key facts

Study ID

NCT03780543

Run by

Assembly Biosciences

People needed

92

Starts

2018-12-20

Expected to finish

2021-04-26

Last updated by the study team

2023-04-19

Who can join

Age: 18 and older, up to 71. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cedars-Sinai Medical Center — Beverly Hills, California, United States
• Southern California Research Center — Coronado, California, United States
• Coalition of Inclusive Medicine — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Research and Education — San Diego, California, United States
• Medical Associates Research Group — San Diego, California, United States
• Quest Clinical Research — San Francisco, California, United States
• Stanford University Medical Center — Stanford, California, United States
• University of Miami Hospital and Clinics — Miami, Florida, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Digestive Disease Associates — Catonsville, Maryland, United States
• Infectious Disease Care — Hillsborough, New Jersey, United States
• Sing Chan, MD — Flushing, New York, United States
• NYU Langone Health — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Xiaoli Ma, MD — Philadelphia, Pennsylvania, United States
• GI Research Institute — Vancouver, British Columbia, Canada
• Toronto Liver Center — Toronto, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• University of Hong Kong, Queen Mary Hospital — Hong Kong, Hong Kong
• Auckland Clinical Studies — Auckland, New Zealand
• Waikato Hospital — Hamilton, New Zealand
• King's College London — London, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.