This is a randomized, open label, multicenter Phase 2 study investigating the safety and antiviral activity of AB-729 in combination with ongoing NA therapy and short courses of Peg-IFNα-2a in subjects with CHB.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
subcutaneous injection
subcutaneous injection
Arizona Liver Health
Chandler, Arizona, United States
Arizona Liver Health
Tucson, Arizona, United States
The Frequency and Severity of Treatment Emergent Adverse Events (TEAEs), Discontinuations Due to AEs and Lab Abnormalities After Dosing With AB-729 Plus Peg-IFNα-2a
Time frame: Up to 124 weeks
Change From Baseline in HBsAg and Other Virologic Markers at Each Time Point
Time frame: Up to 124 weeks
Proportion of Subjects With HBsAb Seroconversion at Each Timepoint
Time frame: Up to 124 weeks
Proportion of Subjects Who Are Eligible to Stop NA After Week 24 of Follow up
Time frame: Up to 76 weeks
Proportion of Subjects Who Discontinue NA and Subsequently Restart NA Therapy After Meeting Criteria
Time frame: Up to 124 weeks
Proportion of Subjects Who Discontinue NA and Subsequently Meet Protocol Defined Clinical Relapse Criteria. Proportion of Subjects Who Discontinue NA and Subsequently Meet Protocol Defined Viral Relapse Criteria
Time frame: Up to 124 weeks
Post-dose Plasma Concentrations of AB-729 Anti-sense (AS), AB-729 AS(N-1)3', and AB-729 AS(N-2)3' at Selected Timepoints
Time frame: Up to 40 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research and Education, Inc.
San Diego, California, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Henry Ford Health System
Detroit, Michigan, United States
ID Care
Hillsborough, New Jersey, United States
Nepean Hospital
Kingswood, New South Wales, Australia
St Vincent's Hospital Melbourne
Melbourne, Victoria, Australia
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
...and 7 more locations