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The Mycophenolate Pregnancy Registry

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About the study

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.

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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

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

EXCLUSION CRITERIA

Exclusion Criteria:

Pregnancies for which there is paternal exposure only
Pregnancies occurring outside the U.S.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details

Contition

Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases

Participants needed

500

Est. Completion Date

May 30, 2025

Treatment type

Observational

Sponsor

Genentech, Inc.

ClinicalTrials.gov identifier

NCT01733082

Study number

ML22679

Understanding Clinical Trials

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