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NCT04156906

RHD Genotype Matched Red Cells for Anti-D

Completed EARLY_PHASE1 Results posted Last updated 2 May 2025
What this trial tests

EARLY_PHASE1 trial testing D+ RH genotype matched red cell units for transfusion in Sickle Cell Disease in 5 participants. Completed in 4 October 2024.

Timeline
8 July 2020
Primary endpoint
4 March 2024
4 October 2024

Quick facts

Lead sponsorChildren's Hospital of Philadelphia
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment5
Start date8 July 2020
Primary completion4 March 2024
Estimated completion4 October 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Children's Hospital of Philadelphia

Who can join

8 and older, any sex, with Sickle Cell Disease or Anti-D Antibodies. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Anti-D Recurrence Primary · Through study completion and follow-up phase, an average of 10 months per participant

To determine safety of providing RH genotype match red cells to patients with a history of anti-D, we observed if anti-D reappearance occurred or evidence of hemolysis of transfused red cells.

GroupValue95% CI
D+ RH Genotype Matched Red Blood Cell Transfusion0
D+ RH Genotype Matched Red Blood Cell Transfusion5

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Genotyped RhD+ red cells for D-positive patients with sickle cell disease with conventional RHD and unexpected anti-D.
    Chou ST, Mewha J, Friedman DF, Lazariu V, et al · · 2024 · cited 4× · PMID 39172743 · DOI 10.1182/blood.2024025602

Verify or expand the search:

Other recruiting trials for Sickle Cell Disease

Currently open trials in the same condition.

Other Children's Hospital of Philadelphia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04156906.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing