Qualitymetric

• Approximately 50% of the first 22 Part 1 participants experienced on-treatment ALT elevations, and protocol management criteria were amended because some elevations were prolonged.
• New enrollment was temporarily halted in December 2022 after significant ALT elevations were observed more frequently in Part 2 participants with screening or baseline HBsAg >10,000 IU/mL.
• Enrollment was not reopened because the sponsor discontinued further investment in its hepatitis B and D discovery and development programs.
• Part 2 open-label treatment was reduced to Week 96 and follow-up to 24 weeks under protocol amendment 5.
• Sustained HBV response was not collected or analyzed because follow-up was shortened and participants continued NA treatment during follow-up.

These findings describe the trial, not the service provider’s performance or responsibility.

• Recruitment was permanently stopped before full enrolment was achieved, resulting in a smaller-than-planned sample size.
• Early recruitment termination meant that the planned Bayesian Optimal Interval dose-escalation process did not meet its pre-specified stopping criteria.
• Limited available biopsy material constrained interpretation of chronic graft-related findings.
• Mixed lymphocyte reaction assay data were limited by low peripheral blood mononuclear cell availability after anti-thymocyte globulin lymphodepletion, precluding conclusions.

These findings describe the trial, not the service provider’s performance or responsibility.