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Clinical Trial Summary

The purpose of this study is to evaluate the safety in mother and neonate/infant of M281 administered to pregnant women who are at high risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN). The effectiveness of the investigational drug M281 will be measured by looking at the percentage of participants with live birth at or after gestational age (GA) 32 weeks and without a need for an intrauterine transfusion (IUT) throughout their entire pregnancy.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Hemolysis
  • Hemolytic Disease of the Fetus and Newborn

NCT number NCT03842189
Study type Interventional
Source Janssen Research & Development, LLC
Contact
Status Active, not recruiting
Phase Phase 2
Start date April 5, 2018
Completion date November 8, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05912517 - A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN) Phase 3