The Mycophenolate Pregnancy Registry
- Conditions
- Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases
- Registration Number
- NCT01733082
- Lead Sponsor
- Genentech, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 500
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fetal Outcomes: Incidence of Congenital Disorders Approximately 13 years Time/Duration of Mycophenolate Exposure Approximately 13 years Maternal Medical/Demographic Characteristics Approximately 13 years Maternal Outcomes: Incidence of Pregnancy Complications Approximately 13 years Indications for Mycophenolate use Approximately 13 years Mycophenolate Dose/Regimen Approximately 13 years
- Secondary Outcome Measures
Name Time Method Occurrence of Educational Counseling on the Increased Risks of Birth Defects With Mycophenolate Therapy Approximately 13 years
Trial Locations
- Locations (1)
Quintiles Outcome
🇺🇸Cambridge, Massachusetts, United States