Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases
Conditions
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.
Interventions
None listed
Sponsors
Zydus Pharmaceuticals
Meitheal Pharmaceuticals, Inc.
Mylan Pharmaceuticals Inc
Novartis Pharmaceuticals
Rising Pharma Holdings, Inc.
RK Pharma Inc.
Sandoz
Strides Pharma, Inc
Teva Pharmaceuticals USA
TWi Pharmaceuticals, Inc.
VistaPharm, Inc.
Wuxi Fortune Pharmaceutical Co., Ltd
Genentech, Inc.
Accord Healthcare, Inc.
Alkem Laboratories Ltd
Ascend Laboratories, LLC
Amneal Pharmaceuticals, LLC
Amta labs Limited
Apotex Inc.
Avet Lifesciences Limited
Azurity Pharmaceuticals
Biocon Pharma Limited
Concord Biotech Limited
Endo USA Inc., a Keenova Therapeutics Company
Hetero Labs Limited, Unit-V
Hikma Pharmaceuticals USA Inc.
Hisun Pharmaceuticals
Jubilant Cadista Pharmaceuticals, Inc.
Lannett Company, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maternal Outcomes: Incidence of Pregnancy Complications | Approximately 13 years |
| Fetal Outcomes: Incidence of Congenital Disorders | Approximately 13 years |
| Time/Duration of Mycophenolate Exposure | Approximately 13 years |
| Mycophenolate Dose/Regimen | Approximately 13 years |
| Indications for Mycophenolate use | Approximately 13 years |
| Maternal Medical/Demographic Characteristics | Approximately 13 years |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of Educational Counseling on the Increased Risks of Birth Defects With Mycophenolate Therapy | Approximately 13 years |
Countries
United States
Contacts
CONTACTReference Study ID Number: ML22679 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Genentech, Inc.
Outcome results
None listed