The Mycophenolate Pregnancy Registry
NCT01733082 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500
Last updated 2026-05-14
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
- Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases
Sponsors & Collaborators
-
Accord Healthcare, Inc.
collaborator INDUSTRY -
Alkem Laboratories Ltd
collaborator INDUSTRY -
Ascend Laboratories, LLC
collaborator UNKNOWN -
Amneal Pharmaceuticals, LLC
collaborator INDUSTRY -
Amta labs Limited
collaborator UNKNOWN -
Apotex Inc.
collaborator INDUSTRY -
Avet Lifesciences Limited
collaborator UNKNOWN -
Azurity Pharmaceuticals
collaborator INDUSTRY -
Biocon Pharma Limited
collaborator UNKNOWN -
Concord Biotech Limited
collaborator UNKNOWN -
Endo Pharmaceuticals
collaborator INDUSTRY -
Hetero Labs Limited, Unit-V
collaborator UNKNOWN -
Hikma Pharmaceuticals USA Inc.
collaborator UNKNOWN -
Hisun Pharmaceuticals
collaborator UNKNOWN -
Jubilant Cadista Pharmaceuticals, Inc.
collaborator UNKNOWN -
Lannett Company, Inc.
collaborator INDUSTRY -
Meitheal Pharmaceuticals, Inc.
collaborator INDUSTRY -
Mylan Pharmaceuticals Inc
collaborator INDUSTRY - collaborator INDUSTRY
-
Rising Pharma Holdings, Inc.
collaborator UNKNOWN -
RK Pharma Inc.
collaborator UNKNOWN - collaborator INDUSTRY
-
Strides Pharma, Inc
collaborator UNKNOWN -
Teva Pharmaceuticals USA
collaborator INDUSTRY -
TWi Pharmaceuticals, Inc.
collaborator UNKNOWN -
VistaPharm, Inc.
collaborator INDUSTRY -
Wuxi Fortune Pharmaceutical Co., Ltd
collaborator UNKNOWN -
Zydus Pharmaceuticals
collaborator UNKNOWN -
Genentech, Inc.
lead INDUSTRY
Principal Investigators
-
Clinical Trials · Genentech, Inc.
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-11-20
- Primary Completion
- 2040-12-31
- Completion
- 2040-12-31
Countries
- United States
Study Locations
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