This is a long term follow-up study for chronic hepatitis B (CHB) subjects who have received imdusiran treatment in a prior clinical trial, stopped NA therapy during that trial, and remain off therapy. Subjects may enroll after completing the end of study visit (baseline visit within 12 weeks ± 1 week from the end of study \[EOS\] visit) from their imdusiran clinical trial (the "parent study"). No interventions will be performed in this study other than blood sample collections, review of current medications, and reporting of any adverse events related to study procedures or NA therapy if restarted. Study participation will be for approximately 2 years (to complete a total of at least 3 years of follow-up while off NA therapy, inclusive of parent study participation).
Study Type
OBSERVATIONAL
Enrollment
50
This is a rollover study
Research and Education Inc.
San Diego, California, United States
RECRUITINGUniversity of Miami Miller School of Medicine
Miami, Florida, United States
NOT_YET_RECRUITINGInfectious Disease Care
Hillsborough, New Jersey, United States
RECRUITINGThe Alfred Hospital
Melbourne, Victoria, Australia
RECRUITINGFiona Stanley Hospital
Murdoch, Australia
NOT_YET_RECRUITINGPrince of Wales Hospital
Shatin, New Territories, Hong Kong
RECRUITINGQueen Mary Hospital
Hong Kong, Hong Kong
RECRUITINGArensia Exploratory Medicine Moldova
Chisinau, Moldova
RECRUITINGAsan Medial Center
Seoul, South Korea
NOT_YET_RECRUITINGChanghua Christian Hospital
Changhua, Taiwan
RECRUITING...and 8 more locations
To evaluate the durability of effect of imdusiran on HBV parameters
Change from pre-"parent" study baseline and over time in HBsAg, HBV DNA, and hepatitis B surface antibody (HBsAb) at each timepoint.
Time frame: Up to 96 weeks
To evaluate the durability of effect of imdusiran on HBV parameters
Proportion of subjects who remain off NA therapy and duration off NA therapy, if applicable
Time frame: Up to 96 weeks
To evaluate the durability of effect of imdusiran on HBV parameters
Proportion of subjects who restart NA therapy, if applicable
Time frame: Up to 96 weeks
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