Recruiting

Imdusiran

Sponsor:

Arbutus Biopharma Corporation

Code:

NCT06277037

Conditions

Long Term Follow-up

Eligibility Criteria

Sex: All

Age: 20 - 70

Healthy Volunteers: Not accepted

Interventions

Non-interventional

Study Details

Brief 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).

Conditions

Long Term Follow-up

Study ID

NCT06277037

Start date

Jul 11, 2024

Status verified date

Nov, 2024

Completion date

Oct 30, 2029

Anticipated

Primary completion date

Aug 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Have participated in a prior imdusiran clinical trial,
  • Have discontinued NA therapy in that trial and remain off NA therapy,
  • Have completed less than 3 years of follow-up visits after NA discontinuation in the parent study.
  • Have the ability to review and provide signed informed consent which includes compliance with all protocol-specified visit schedules and requirements.

Exclusion Criteria:

  • Not applicable

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

Non-interventional

This is a rollover study

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Research and Education Inc.

Recruiting

San Diego, California, United States, 92105

Infectious Disease Care

Recruiting

Hillsborough, New Jersey, United States, 08844

More Information

Sponsor

Arbutus Biopharma Corporation

Last update posted

Nov 27, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arbutus Biopharma Corporation on 2024-11-27.