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The Mycophenolate Pregnancy Registry

RECRUITINGSponsored by Genentech, Inc.
Actively Recruiting
SponsorGenentech, Inc.
Started2012-11-20
Est. completion2026-10-31
Eligibility
SexFEMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT01733082

Summary

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.

Eligibility

Sex: FEMALEHealthy volunteers accepted
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.

Conditions3

Heart DiseaseHeart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune DiseasesLiver Disease

Locations1 site

Quintiles Outcome
Cambridge, Massachusetts, 02139

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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