The Mycophenolate Pregnancy Registry
Part of paid clinical trials in Cambridge, Massachusetts.
- Sponsor
- Genentech, Inc.
- Study ID
- NCT01733082
- Status
- Recruiting
Conditions
- Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases
Eligibility Criteria
- Sex
- FEMALE
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- Nov 20, 2012
- Status verified
- May 2026
- Primary completion
- Dec 31, 2040
- Completion
- Dec 31, 2040
Study Design
- Enrollment
- 500 participants (estimated)
Arms
- Arm: Pregnant Patients Exposed to Mycophenolate
Primary Outcome Measure
Maternal Outcomes: Incidence of Pregnancy Complications [ Time Frame: Approximately 13 years ]
Central Contacts
- Reference Study ID Number: ML22679 https://forpatients.roche.com/888-662-6728 (U.S. and Canada)
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Quintiles Outcome | Cambridge | Massachusetts | 02139 | - |