The Mycophenolate Pregnancy Registry



Status:Recruiting
Conditions:Infectious Disease, Gastrointestinal
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:8/3/2016
Start Date:November 2012
End Date:December 2016
Contact:Reference Study ID Number: ML22679 www.roche.com/about_roche/roche_worldwide.htm
Email:global.rochegenentechtrials@roche.com
Phone:888-662-6728 (U.S. and Canada)

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria
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.


Inclusion Criteria:

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

Exclusion Criteria:

- Pregnancies for which there is paternal exposure only

- Pregnancies occurring outside the U.S.
We found this trial at
1
site
Clinical Trial Facility in Cambridge Massachusetts
Cambridge, Massachusetts 02142
?
mi
from
Cambridge, MA
Click here to add this to my saved trials