Early Phase 1
N=5
RHD Genotype Matched Red Cells for Anti-D
Sickle Cell Disease · Anti-D Antibodies
Bottom Line
View on ClinicalTrials.gov: NCT04156906 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Anti-D Recurrence — 0; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- D+ RH genotype matched red cell units for transfusion (Biological)
- Age
- Pediatric, Adult, Older Adult · 8+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-D Recurrence |
0; 5 | — |
Summary
This is a pilot study to evaluate the feasibility and safety of providing RH genotype matched D+ Red Blood Cells (RBCs) to chronically transfused patients with sickle cell disease (SCD) who type D+ but have formed anti-D and are currently transfused with D- RBC (Red Blood Cell) units.
Eligibility Criteria
Inclusion Criteria
- Subjects age > 8 years old
- Diagnosis of SCD, all genotypes
- Require chronic red cell transfusion therapy
- History of anti-D
- RH genotype predicts D+ expression
Exclusion Criteria
- Rare RH genotype that would preclude sufficient RBC units
- Antigen negative requirements due to alloimmunization that would preclude sufficient RBC units
Data sourced from ClinicalTrials.gov (NCT04156906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.