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Recruiting
NCT01733082
The Mycophenolate Pregnancy Registry
Conditions: Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases
Sex: Female
Healthy volunteers: No
Enrollment: 500
Sponsor: Genentech, Inc.
Location: Quintiles Outcome Cambridge Massachusetts
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT01733082). StuddyBuddy aggregates publicly available trial information.
