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Trial record 2 of 6 for:    M281

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)

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ClinicalTrials.gov Identifier: NCT03842189
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 5, 2021
Sponsor:
Information provided by (Responsible Party):
Momenta Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE February 7, 2019
First Posted Date  ICMJE February 15, 2019
Last Update Posted Date February 5, 2021
Actual Study Start Date  ICMJE June 10, 2019
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
  • Number of Participants With Adverse Events (AEs) [ Time Frame: From signing of informed consent up to approximately 24 weeks post-delivery for mothers; up to approximately 96 weeks post birth for neonates ]
  • Number of Participants With Live Birth at or After Gestational Age (GA) Week 32 and no Intrauterine Transfusion (IUT) Throughout Their Entire Pregnancy [ Time Frame: Up to approximately GA Week 37 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2019)
  • Number of Participants With Adverse Events (AEs) [ Time Frame: From signing of informed consent up to approximately 24 weeks post-delivery for mothers; up to approximately 96 weeks post birth for neonates ]
  • Number of Participants With Live Birth at or After Gestational Age (GA) Week 32 and no Intrauterine Transfusion (IUT) throughout the study [ Time Frame: Up to approximately GA Week 37 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2019)
  • Global Clinical Outcome (GCO) Rank Score (GCO Rank) [ Time Frame: Up to approximately GA Week 37; up to approximately 12 weeks post birth ]
  • Number of Participants With GCO Clinically Meaningful Classification (GCO Class) [ Time Frame: Up to approximately GA Week 37; up to approximately 12 weeks post birth ]
  • Number of Participants With live Birth [ Time Frame: Up to approximately GA Week 37 ]
  • Number of Participants at GA Week 24 Without an IUT [ Time Frame: GA Week 24 ]
  • Gestational age at First IUT [ Time Frame: Up to approximately GA Week 37 ]
  • Number of IUTs Required [ Time Frame: Up to approximately GA Week 37 ]
  • Gestational age at Delivery [ Time Frame: Up to approximately GA Week 37 ]
  • Number of Participants With Fetal Hydrops [ Time Frame: Up to approximately 24 weeks post birth ]
    Fetal hydrops is severe edema in the skin and serous cavities of the neonate.
  • Number of Neonates Requiring Phototherapy [ Time Frame: Up to approximately 24 weeks post birth ]
  • Number of Neonates Requiring Exchange transfusions [ Time Frame: Up to approximately 24 weeks post birth ]
  • Number of Days of Postnatal Phototherapy Required by Neonate [ Time Frame: Up to approximately 24 weeks post birth ]
  • Number of Neonates Requiring Simple Transfusions in the First 12 weeks of Life [ Time Frame: Up to 12 weeks post birth ]
  • Number of Simple Transfusions Required by Neonate in the First 12 weeks of Life [ Time Frame: Up to 12 weeks post birth ]
  • Percentage of Maternal Fc Receptor (FcRn) Receptor Occupancy (RO) [ Time Frame: GA Week 14 to approximately GA Week 36 ]
  • Maternal Levels of Total Immunoglobulin G (IgG) [ Time Frame: GA Week 14 to approximately GA Week 36 ]
  • Maternal Levels of Alloantibodies [ Time Frame: GA Week 14 to approximately GA Week 36 ]
  • Mean Concentration of M281 in Maternal Participants [ Time Frame: GA Week 14 to approximately GA Week 36 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE A Multicenter, Open-label 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)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hemolytic Disease of the Fetus and Newborn
Intervention  ICMJE Drug: M281
Participants will receive once weekly intravenous (IV) infusions of M281
Study Arms  ICMJE Experimental: M281
Intervention: Drug: M281
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 12, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Approximately 15 eligible participants and their offspring will be enrolled
  • Each participant must meet all of the following criteria to be enrolled in the study:

    • Female and ≥18 years of age
    • Pregnant to an estimated gestational age of between 8 up to 14 weeks
  • A previous pregnancy with a gestation that included at least one of the following prior to week 24 gestation:

    • Severe fetal anemia, defined as hemoglobin ≤0.55 multiples of the median (MOM) for gestational age
    • Fetal hydrops with peak systolic velocity MOM ≥1.5
    • Stillbirth with fetal or placental pathology indicative of hemolytic disease of the fetus and newborn (HDFN)
  • Maternal alloantibody titers for anti-D of ≥32, or anti-Kell titers ≥4
  • Free fetal deoxyribonucleic acid consistent with an antigen positive fetus (blood sample taken from mother)
  • MaternaI evidence for Immunity to measles mumps, rubella, and varicella, as documented by serologies performed during Screening. If initial serologies are borderline or negative, they may be repeated at a second lab. Alternatively, vaccination records can be used to support evidence of immunity.
  • Screening immunoglobulin G and albumin levels within the laboratory normal range for gestational age of pregnancy
  • Willing to receive standard of care with intrauterine transfusion if clinically indicated
  • Agree to receive recommended vaccinations per local standard of care for both mother and child throughout the course of the study

Exclusion Criteria:

  • Currently pregnant with multiples (twins or more)
  • Pre-eclampsia In current pregnancy or history of pre-eclampsia in a previous pregnancy
  • Gestational hypertension in the current pregnancy
  • Current unstable hypertension
  • History of severe or recurrent pyelonephritis, 4 or more lower urinary tract infections in the past year or in a previous pregnancy
  • History of genital herpes infection
  • Active Infection at Screening or Baseline with Coxsackie, syphilis, cytomegalovirus, toxoplasmosis or herpes simplex 1 or 2, as evidenced by clinical signs and symptoms (evidence for prior Infection or exposure, but without clinical signs and symptoms of active infection is acceptable)
  • Active infection with tuberculosis as evidenced by positive QuantiFERON-tuberculosis testing
  • Requires treatment with corticosteroids or immunosuppression for disorders unrelated to the pregnancy (use of low-potency topical corticosteroids or intra-articular corticosteroids is permitted)
  • Received live vaccine within 3 months prior to first intravenous infusion of nipocalimab
  • Currently receiving an antibody-based drug or an Fc-fusion protein drug
  • Received plasmapheresis and/or intravenous immunoglobulin during the current pregnancy for treatment of HDFN
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Momenta General Queries +1 617-491-9700 ClinicalTrialInfo@momentapharma.com
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Germany,   Netherlands,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03842189
Other Study ID Numbers  ICMJE MOM-M281-003
2017-004958-42 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Momenta Pharmaceuticals, Inc.
Study Sponsor  ICMJE Momenta Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Momenta General Queries Momenta Pharmaceuticals, Inc.
PRS Account Momenta Pharmaceuticals, Inc.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP