Study of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab in Subjects With Chronic HBV Infection

Sponsor
Arbutus Biopharma Corporation
Study ID
NCT06245291
Phase
PHASE2
Status
Withdrawn

Conditions

  • Hepatitis B, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Imdusiran — DRUG
    subcutaneous injection
  • Durvalumab — DRUG
    intravenous injection

Study Details

This is a phase 2a, open-label, multicenter study investigating the safety, tolerability, and antiviral activity of durvalumab administered at targeted times during a 48-week treatment period of imdusiran in virologically-suppressed CHB subjects

Key Dates

First listed
Feb 7, 2024
Start date
May 1, 2024
Status verified
Jun 2024
Primary completion
Aug 1, 2024
Completion
Aug 1, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at early and mid-treatment period timepoints
  • Experimental: Cohort B
    Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at mid and late-treatment period timepoints
  • Experimental: Cohort C
    Imdusiran 60 mg SC Q8 weeks + nucleos(t)ide analog for 48 weeks + durvalumab at 2 late treatment period timepoints

Primary Outcome Measure

To evaluate the safety and tolerability of imdusiran and durvalumab in NA suppressed CHB subjects [ Time Frame: Up to 96 weeks ]

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