Condition: Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases · Sponsor: Genentech, Inc.
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.
This description comes directly from the study's public registry record.
Reference Study ID Number: ML22679 https://forpatients.roche.com/ No attachments to email below. · 888-662-6728 (U.S. and Canada) · global-roche-genentech-trials@gene.com
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
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| Quintiles Outcome | Cambridge, Massachusetts, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT01733082