RECRUITING
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The Mycophenolate Pregnancy Registry
The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes, fetal and infant outcomes after exposure. Early and later term pregnancy outcomes will be solicited at selected gestational time points. Structural and functional birth defects identified in the perinatal period through one year of life will be collected and classified. This is a non-proprietary registry and is a component of a comprehensive pregnancy Risk Evaluation and Mitigation Strategy (REMS) plan required by the FDA for all mycophenolate-formulations, including CellCept, Myfortic and any generic formulations.
Conditions:
🦠 Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases
🗓️ Study Start (Actual) 30 November 2012
🗓️ Primary Completion (Estimated) 30 May 2025
✅ Study Completion (Estimated) 30 May 2025
👥 Enrollment (Estimated) 500
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Cambridge, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Pregnancy and reported maternal exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment

    Exclusion Criteria:

    • * Pregnancies for which there is paternal exposure only
    • * Pregnancies occurring outside the U.S.
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 November 2012
  • First Submitted that Met QC Criteria 23 November 2012
  • First Posted 26 November 2012

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 July 2024
  • Last Update Posted 8 July 2024
  • Last Verified July 2024
I'm interested ...!!