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The Mycophenolate Pregnancy Registry
Sponsor: Genentech, Inc.
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.
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2012-11-20
Completion Date
2040-12-31
Last Updated
2026-03-18
Healthy Volunteers
No
Locations (1)
Quintiles Outcome
Cambridge, Massachusetts, United States