Recruiting
Phase 1
Phase 2

RH Genotype

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT04156893

Conditions

Sickle Cells Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Red cell units that are genotype matched at the RHD and RHCE loci

Study Details

Brief summary:

To determine the feasibility and efficacy of matching donor red cells by RH genotype for a cohort of chronically transfused patients with SCD.

Conditions

Sickle Cells Disease

Study ID

NCT04156893

Start date

Jan 30, 2020

Status verified date

Apr, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects age >6 months
  • Diagnosis of SCD, all genotypes
  • Require a period of chronic red cell transfusion therapy
  • Subject/parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion Criteria:

  • Rare RH genotype that would preclude identification of sufficient RBC units
  • Antigen negative requirements due to alloimmunization that would preclude identification of sufficient RBC units
  • Alloimmunized to D antigen
  • Rh alloimmunized patients for whom providing RH genotype matched blood would expose the patient to an antigen that would not be consistent with standard of care and blood bank protocols
  • Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RH genotype matched red cell transfusions

Subjects will receive RH genotyped matched red cell units for transfusion in addition to standard serologic C, E, and K antigen matching and being hemoglobin S negative, which is our institutional standard of care for patients with Sickle Cell Disease.

Interventions

Red cell units that are genotype matched at the RHD and RHCE loci

Patients will be provided with red cell units that are C, E, and K antigen matched (standard of care for patients with SCD) and genotype matched at the RHD and RHCE loci.

Primary outcome measure

  • Determine the treatment efficacy by monitoring the rate of Rh alloimmunization [ Time Frame: 3.5 years ]
  • Determine the feasibility of identifying sufficient RH genotype matched units [ Time Frame: 3.5 years ]

Central Contacts and Locations

Central contacts

Stella Chou, MD

215-590-0947chous@chop.edu

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Stella Chou, MD

215-590-0947chous@chop.edu

Principal Investigator:

Stella Chou, MD

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Keywords

  • Chronic Transfusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-04-27.