Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729)

Condition(s) studied

Investigational drug(s) / intervention(s)

Non-interventional: This is a rollover study

Study summary

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).

Eligibility

Primary outcome measure(s)

• To evaluate the durability of effect of imdusiran on HBV parameters — Up to 96 weeks
  Change from pre-"parent" study baseline and over time in HBsAg, HBV DNA, and hepatitis B surface antibody (HBsAb) at each timepoint.
• To evaluate the durability of effect of imdusiran on HBV parameters — Up to 96 weeks
  Proportion of subjects who remain off NA therapy and duration off NA therapy, if applicable
• To evaluate the durability of effect of imdusiran on HBV parameters — Up to 96 weeks
  Proportion of subjects who restart NA therapy, if applicable

Trial sites (18)