Trials / Recruiting
RecruitingNCT01733082
The Mycophenolate Pregnancy Registry
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2012-11-20
- Primary completion
- 2040-12-31
- Completion
- 2040-12-31
- First posted
- 2012-11-26
- Last updated
- 2026-04-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01733082. Inclusion in this directory is not an endorsement.