The Mycophenolate Pregnancy Registry

Genentech

Status: Enrolling

Conditions: Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01733082

ML22679

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Cohort