The Mycophenolate Pregnancy Registry
Overview
- Phase
- N/A
- Intervention
- Pregnant Patients Exposed to Mycophenolate
- Conditions
- Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases
- Sponsor
- Genentech, Inc.
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Fetal Outcomes: Incidence of Congenital Disorders
- Status
- Recruiting
- Last Updated
- 17 days ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Pregnant Patients Exposed to Mycophenolate
Outcomes
Primary Outcomes
Fetal Outcomes: Incidence of Congenital Disorders
Time Frame: Approximately 13 years
Time/Duration of Mycophenolate Exposure
Time Frame: Approximately 13 years
Maternal Medical/Demographic Characteristics
Time Frame: Approximately 13 years
Maternal Outcomes: Incidence of Pregnancy Complications
Time Frame: Approximately 13 years
Indications for Mycophenolate use
Time Frame: Approximately 13 years
Mycophenolate Dose/Regimen
Time Frame: Approximately 13 years
Secondary Outcomes
- Occurrence of Educational Counseling on the Increased Risks of Birth Defects With Mycophenolate Therapy(Approximately 13 years)