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

Conditions

• Long Term Follow-up

Eligibility Criteria

Sex

ALL

Age

20 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Non-interventional — OTHER
  This is a rollover study

Study Details

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).

Key Dates

Start date

Jul 11, 2024

Status verified

Nov 2024

Primary completion

Aug 30, 2029

Completion

Oct 30, 2029

Study Design

Enrollment

50 participants (estimated)

Primary Outcome Measure

To evaluate the durability of effect of imdusiran on HBV parameters [ Time Frame: Up to 96 weeks ]

Central Contacts

• Michael Child
  267-332-6213
  [email protected]

Locations (3)

Find similar trials in San Diego, CA

Related Studies

• Long Term Follow-up Study for Subjects Administered CLBR001
  Enrolling By Invitation · Calibr, a division of Scripps Research · Indianapolis, Indiana