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.
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01733082
Ages eligible for Study
Genders eligible for Study
Accepts Healthy Volunteers
Pregnancy and reported maternal exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment
Pregnancies for which there is paternal exposure only
Pregnancies occurring outside the U.S.
All locations for NCT01733082
United States (1)
Cambridge, Massachusetts, United States, 02139
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View full eligibility
Tris trial is registered with FDA with number: NCT01733082. The sponsor of the trial is Genentech, Inc. and it is looking for 500 volunteers for the current phase. Official trial title: The Mycophenolate Pregnancy Registry
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