The Mycophenolate Pregnancy Registry

  • Cardiovascular Disorder
  • Cardiac Transplant
  • Kidney Disorder
  • Renal Transplant
  • Autoimmune Disorder
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Recruiting

This study runs in
Country
  • United States
Study Identifier:

NCT01733082 ML22679

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Study 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
      N/A Phase
      NCT01733082, ML22679 Study Identifier
      Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases Condition
      Official Title

      The Mycophenolate Pregnancy Registry

      Eligibility Criteria

      Female Gender
      All Ages Age
      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.

      For the latest version of this information please go to www.forpatients.roche.com

       

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