14-HMedIdeS-04
14 evidence topics · 3 sources
Objective
Protocol objective
Location and study date
Study design
Protocol study design
Eligibility criteria
Treatment
Protocol imlifidase dose
Post-transplant immunosuppression in the combined publication
Study outcomes
Rationale for using allograft rejection as the primary endpoint
Endpoint-specific validation
No evidence found.
Statistical analysis description
Number of participants (Planned and analyzed)
Protocol planned enrollment
| Population | Participants |
|---|---|
| Planned | “20” |
Sponsor-reported enrollment for NCT02426684
| Population | Participants |
|---|---|
| Enrolled | “17” |
United States participants in the combined publication
| Population | Participants |
|---|---|
| United States subgroup in the earlier publication | “14” |
Description of analysis sets
Protocol statistical limitation
Results
Participant disposition
No evidence found.
Baseline characteristics
No evidence found.
Efficacy results
HLA-incompatible transplantation: pooled donor-specific antibody reduction across the early studies
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Combined early-trial safety results: pooled, not specific to the United States study
Study limitations
Summary
The protocol describes an exploratory open-label study that was not powered for efficacy endpoints. Planned enrollment was 20 participants, and the later sponsor update reported 17. The earlier combined publication included 14 United States participants and reported several outcomes across 25 participants from both countries. Those pooled efficacy and safety counts must not be treated as outcomes for all 17 participants in this study alone.