The Mycophenolate Pregnancy Registry

  • Autoimmune Disorder
Trial Status:


This trial runs in
  • Cambridge
Trial Identifier:

NCT01733082 ML22679

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      The source of the below information is the publicly available website It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website within a week of any updates, and has not been edited.

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      Trial Summary

      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.

      Genentech, Inc. Sponsor
      NCT01733082 , ML22679 Trial Identifier
      Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases Condition
      Official Title

      The Mycophenolate Pregnancy Registry

      Eligibility Criteria

      Female Gender
      No Healthy Volunteers
      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.

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