Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases Clinical Trial
Official title:
The Mycophenolate Pregnancy Registry
| NCT number | NCT01733082 |
| Other study ID # | ML22679 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 30, 2012 |
| Est. completion date | May 30, 2025 |
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.
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | May 30, 2025 |
| Est. primary completion date | May 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Quintiles Outcome | Cambridge | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Genentech, Inc. | Accord Healthcare, Inc., Alkem Laboratories Ltd, Apotex Corporation, Mylan Pharmaceuticals Inc, Novartis Pharmaceuticals, Pfizer, Roxane Laboratories, Sandoz, Teva Pharmaceuticals USA, Vintage Pharmaceuticals, LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maternal Outcomes: Incidence of Pregnancy Complications | Approximately 13 years | ||
| Primary | Fetal Outcomes: Incidence of Congenital Disorders | Approximately 13 years | ||
| Primary | Time/Duration of Mycophenolate Exposure | Approximately 13 years | ||
| Primary | Mycophenolate Dose/Regimen | Approximately 13 years | ||
| Primary | Indications for Mycophenolate use | Approximately 13 years | ||
| Primary | Maternal Medical/Demographic Characteristics | Approximately 13 years | ||
| Secondary | Occurrence of Educational Counseling on the Increased Risks of Birth Defects With Mycophenolate Therapy | Approximately 13 years |