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EPO-4-Rhesus Study

NCT03104426 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2019-10-02

No results posted yet for this study

Summary

Up to 80% of infants with hemolytic disease due to maternal alloimmunization, treated with IUT, require at least one top-up transfusion for late anemia during the first 3 months of life. Erythropoietin deficiency is also considered as a possible contributing factor to late anemia and therefore we will assess the role of EPO (darbepoetin alfa) in the treatment of these infants.

Conditions

  • Erythroblastosis, Fetal
  • Erythroblastosis Fetalis, Rh Disease
  • Erythroblastosis Fetalis Due to RH Antibodies
  • Erythroblastosis Fetalis Due to Isoimmunization

Interventions

DRUG

Darbepoetin Alfa

Darbepoetin alfa dosage 10microg/kg once a week for 8 weeks

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research

    lead OTHER

Principal Investigators

  • Masja de Haas, MD PhD · Sanquin Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03104426 on ClinicalTrials.gov