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A Study to Characterize the Clinical Course of Pregnant Women and Children at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03755128
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Momenta Pharmaceuticals, Inc.

Study Description
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Brief Summary:
The primary purpose of the study is to characterize the current standard of care, clinical course, and outcomes of pregnant women and their offspring at high risk for early onset severe hemolytic disease of the fetus and newborn (EOS-HDFN).

Condition or disease Intervention/treatment
Early Onset Severe Hemolytic Disease of the Fetus and Newborn (EOS-HDFN) Erythroblastosis, Fetal Other: No intervention

Detailed Description:
The outcomes of interest will be assessed from the information collected on the standard of care treatment for EOS-HDFN in pregnant women and their offspring from current pregnancy.
Study Design
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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Prospective Observational Study to Characterize the Clinical Course of Pregnant Women and Children at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn
Actual Study Start Date : August 12, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
Pregnant women and their offspring from current pregnancy Other: No intervention
No investigational drugs will be administered as part of the study


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Live Birth at or After Gestational Age (GA) Week 32 Without Intrauterine Transfusion (IUT) [ Time Frame: GA Week 32 through GA Week 37 ]

Secondary Outcome Measures :
  1. Percentage of Participants With Live Birth [ Time Frame: Up to approximately GA Week 37 ]
  2. Percentage of Participants at GA Week 24 Without an IUT [ Time Frame: Week 24 ]
  3. GA at First IUT [ Time Frame: Up to approximately GA Week 37 ]
  4. Number of IUTs Required [ Time Frame: Up to approximately GA Week 37 ]
  5. Percentage of Participants With Fetal Hydrops [ Time Frame: Post-Birth through Age 3 Months ]
  6. Percentage of Neonates Requiring Phototherapy [ Time Frame: Post-Birth through Age 3 Months ]
  7. Percentage of Neonates Requiring Exchange Transfusions [ Time Frame: Post-Birth through Age 3 Months ]
  8. Number of days of phototherapy required by neonate [ Time Frame: Post-Birth through Age 3 Months ]
  9. Percentage of Neonates Requiring Simple Transfusions in the First 3 Months of Life [ Time Frame: Post-Birth through Age 3 Months ]
  10. Number of Simple Transfusions Required by Neonate in the First 3 Months of Life [ Time Frame: Post-Birth through Age 3 Months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants must have an obstetrical history of severe fetal anemia, hydrops, or stillbirth related to hemolytic disease of the fetus and newborn, have alloantibody titers for anti-D ≥32 or anti-Kell titers ≥4, and be currently pregnant with an antigen-positive fetus. Eligible women may enter the study at any time during the current pregnancy prior to delivery.
Criteria
Pregnant female participants must be ≥18 years of age with an estimated Gestational Age of ≥ 8 weeks; not currently pregnant with multiples (twins or more); and no other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03755128


Contacts
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Contact: Momenta General Queries +1 617-715-5094 ClinicalTrialInfo@momentapharma.com

Locations
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United States, New York
Momenta Investigational Site Recruiting
New York, New York, United States, 10032
United States, Ohio
Momenta Investigational Site Recruiting
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Momenta Investigational Site Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Momenta Investigational Site Recruiting
Houston, Texas, United States, 77030
United States, Utah
Momenta Investigational Site Recruiting
Salt Lake City, Utah, United States, 84132
Australia, New South Wales
Momenta Investigational Site Recruiting
Sydney, New South Wales, Australia, 2170
Australia, Victoria
Momenta Investigational Site Recruiting
Parkville, Victoria, Australia, 3052
Belgium
Momenta Investigational Site Recruiting
Leuven, Flemish Brabant, Belgium, 3000
Canada, British Columbia
Momenta Investigational Site Suspended
Vancouver, British Columbia, Canada, V6H 3N1
Germany
Momenta Investigational Site Recruiting
Giessen, Hessen, Germany, 35392
Netherlands
Momenta Investigational Site Recruiting
Leiden, Zuid-Holland, Netherlands, 2333 ZA
Spain
Momenta Investigational Site Recruiting
Barcelona, Spain, 8028
Momenta Investigational Site Recruiting
Granada, Spain, 18012
Sweden
Momenta Investigational Site Recruiting
Stockholm, Sweden, 17176
United Kingdom
Momenta Investigational Site Suspended
Birmingham, England, United Kingdom, B15 2TG
Momenta Investigational Site Suspended
London, England, United Kingdom, NW1 2BU
Sponsors and Collaborators
Momenta Pharmaceuticals, Inc.
Investigators
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Study Director: Momenta General Queries Momenta Pharmaceuticals, Inc.
More Information
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Responsible Party: Momenta Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03755128    
Other Study ID Numbers: MOM-M281-103
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Momenta Pharmaceuticals, Inc.:
Hemolytic disease of the fetus and newborn (HDFN)
Erythroblastosis, Fetal
Early onset severe hemolytic disease of the fetus and newborn (EOS-HDFN)
M281
Pregnant Women
Additional relevant MeSH terms:
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Erythroblastosis, Fetal
Hemolysis
Pathologic Processes
Fetal Diseases
 Pregnancy Complications
Hematologic Diseases
Infant, Newborn, Diseases
Immune System Diseases