The Mycophenolate Pregnancy Registry
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|ClinicalTrials.gov Identifier: NCT01733082|
Recruitment Status : Unknown
Verified November 2016 by Genentech, Inc..
Recruitment status was: Recruiting
First Posted : November 26, 2012
Last Update Posted : November 2, 2016
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.
|Condition or disease|
|Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||The Mycophenolate Pregnancy Registry|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
- Maternal outcomes: Incidence of pregnancy complications [ Time Frame: approximately 8 years ]
- Fetal outcomes: Incidence of congenital disorders [ Time Frame: approximately 8 years ]
- Time/duration of mycophenolate exposure [ Time Frame: approximately 8 years ]
- Mycophenolate dose/regimen [ Time Frame: approximately 8 years ]
- Indications for mycophenolate use [ Time Frame: approximately 8 years ]
- Maternal medical/demographic characteristics [ Time Frame: approximately 8 years ]
- Occurrence of educational counseling on the risks of birth defects with mycophenolate therapy [ Time Frame: approximately 8 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733082
|Contact: Reference Study ID Number: ML22679 www.roche.com/about_roche/roche_worldwide.htm||888-662-6728 (U.S. and Canada)||email@example.com|
|United States, Massachusetts|
|Cambridge, Massachusetts, United States, 02139|
|Study Director:||Clinical Trials||Genentech, Inc.|