Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Sponsors
GlaxoSmithKline Research & Development Limited
Syneos Health India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all the following criteria apply: 1. Participants who enter the study on stable NA are willing and able to cease their NA treatment in accordance with the NA cessation schedule. 2. Capable of giving informed consent as described in Section 10.1 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
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 |
|---|---|
| A prospective, multi-centre study (B-Sure) to evaluate long term durability of treatment response in chronic hepatitis B participants with and without nucleos(t)ide therapy who have participated in a previous bepirovirsen treatment study ?Timepoint: 132 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To describe changes in disease following NA cessation (in either parent study or B-Sure), as measured by time to HBsAg reversion, time to virologic relapse, time to clinical relapse and time to NA retreatment in on-NA/NA-cessated participants, who achieved PSPO.Timepoint: Time from NA cessation to the first occurrence of HBsAg reversion or first use of any rescue medication. Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication. Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication. Time from NA cessation to NA retreatment. | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, China, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Malaysia, New Zealand, Panama, Philippines, Poland, Republic of Korea, Romania, Russian Federation, Singapore, South Africa, Spain, Taiwan, Thailand, United Kingdom, United States of America
Contacts
Public ContactAtaur Rahman
Syneos Health India Private Limited
Outcome results
None listed