Chronic hepatitis B
Conditions
Interventions
No treatment with bepirovirsen will be administered in this study. Participants without evidence of current or prior cirrhosis, who are controlled on stable NA therapy on study entry will be asked to
participants enrolled in the study should be followed for up to 5 years.
During the study, participant is required to visit the study site regularly to receive protocol specified examinations. Concomi
Sponsors
SATO Takashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants who enter the study on stable NA (Nucleic acid Analog) are willing and able to cease their NA treatment in accordance with the NA cessation schedule. 2. Capable of giving informed consent which includes compliance with the requirements and restrictions listed in the ICF. 3. B-Clear participants specific inclusion criteria: Participants who have previously received at least 1 dose of bepirovirsen AND a. Achieved a PSPO (Parent Study Primary Outcome) in the parent study and who maintained a response until the End of Study (EOS) visit in their parent study (defined as complete responders to bepirovirsen from the parent study) OR b. Demonstrated HBsAg reduction >=1.0 log10 IU/mL from parent study Baseline with HBsAg levels <100 IU/mL and HBV DNA <LLOQ for 24 weeks after the actual end of treatment regimen, in the absence of rescue medication and maintained until their EoS visit in the parent study. 4. B-Well 1 & B-Well 1 2 participants specific inclusion criteria: Participants who have previously received at least 1 dose of Bepirovirsen (or matching placebo where appropriate) AND a. NA cessated at Week 48 in parent study and achieved at least HBsAg <1 IU/ml and HBV DNA <LLOQ at the EOS visit (Week 96) in the parent study OR b. Achieved NA cessation criteria at Week 48 in parent study but have not stopped NA treatment, and are maintaining at least HBsAg <1 IU/ml and HBV DNA <LLOQ at EOS visit (Week 72) of parent study OR c. Did not achieve NA cessation criteria in parent study, but achieved at least HBsAg <1 IU/ml and HBV DNA <LLOQ at EOS visit (Week 72) of parent study.
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: 1. Participants who have participated in / are currently participating in another interventional clinical study exploring HBV treatment since completing their treatment with bepirovirsen. 2. Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participant in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Time from achieving Functional cure (FC) in the parent study to first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication. | — |
Countries
Argentina, Australia, Bulgaria, Canada, China, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Malaysia, Netherlands, New Zealand, Panama, Philippines, Poland, Romania, Russia, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States
Contacts
Public ContactTakashi SATO
Syneos Health Japan K.K.
Outcome results
None listed