An observational study in Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases, sponsored by Genentech, Inc.. Recruiting at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Genentech, Inc. · Observational
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.
655 studies on the registry are indexed under Autoimmune Diseases; 275 are open to participants now.
This study's planned enrollment of 500 is above the median of 300 across 208 observational studies indexed under Autoimmune Diseases.
Browse Autoimmune Diseases studies →Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pregnancy and reported exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment
Exclusion Criteria:
Maternal Outcomes: Incidence of Pregnancy Complications
Time frame: Approximately 13 years
Fetal Outcomes: Incidence of Congenital Disorders
Time frame: Approximately 13 years
Time/Duration of Mycophenolate Exposure
Time frame: Approximately 13 years
Mycophenolate Dose/Regimen
Time frame: Approximately 13 years
Indications for Mycophenolate use
Time frame: Approximately 13 years
Maternal Medical/Demographic Characteristics
Time frame: Approximately 13 years
Occurrence of Educational Counseling on the Increased Risks of Birth Defects With Mycophenolate Therapy
Time frame: Approximately 13 years
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Genentech, Inc.