A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

PHASE2CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

April 5, 2018

Primary Completion Date

August 5, 2024

Study Completion Date

August 5, 2024

Conditions
Hemolytic Disease of the Fetus and Newborn
Interventions
DRUG

M281

Participants will receive once weekly intravenous (IV) infusions of M281

Trial Locations (19)

2170

Liverpool Hospital, Sydney

3000

Universitair Ziekenhuis Leuven, Leuven

10032

Columbia University Medical Center, New York

15232

University of Pittsburgh, Pittsburgh

18016

Hosp. Univ. San Cecilio, Granada

35392

Justus-Liebig-Universität Gießen, Kinderherzzentrum, Giessen

45267

University of Cincinnati, Cincinnati

77030

University of Texas Health Science Center, Houston

78723

Dell Children's Medical Center of Central Texas, Austin

84132

University of Utah, Salt Lake City

94143

University of California San Francisco, San Francisco

97239

Oregon Health and Science University, Portland

V6H 3N1

British Columbia Children's Hospital, Vancouver

M5G 1X5

Mount Sinai Hospital, Toronto

H3T 1C5

CHUM - Centre hospitalier universitaire de Montreal, Montreal

2333 ZA

Leiden University Medical Center, Leiden

SE-141 86

Karolinska Universitetssjukhuset Huddinge, Stockholm

B15 2TG

Birmingham Children's Hospital, Birmingham

WC1E 6DB

University College London Hospitals NHSFT, London

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03842189 - A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN) | Biotech Hunter | Biotech Hunter