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| Name | Class |
|---|---|
| Accord Healthcare, Inc. | INDUSTRY |
| Alkem Laboratories Ltd | INDUSTRY |
| Ascend Laboratories, LLC | UNKNOWN |
| Amneal Pharmaceuticals, LLC |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant Patients Exposed to Mycophenolate |
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| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Educational Counseling on the Increased Risks of Birth Defects With Mycophenolate Therapy | Approximately 13 years |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnancy and reported exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: ML22679 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. and Canada) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quintiles Outcome | Recruiting | Cambridge | Massachusetts | 02139 | United States |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| INDUSTRY |
| Amta labs Limited | UNKNOWN |
| Apotex Inc. | INDUSTRY |
| Avet Lifesciences Limited | UNKNOWN |
| Azurity Pharmaceuticals | INDUSTRY |
| Biocon Pharma Limited | UNKNOWN |
| Concord Biotech Limited | UNKNOWN |
| Endo USA Inc., a Keenova Therapeutics Company | INDUSTRY |
| Hetero Labs Limited, Unit-V | UNKNOWN |
| Hikma Pharmaceuticals USA Inc. | INDUSTRY |
| Hisun Pharmaceuticals | UNKNOWN |
| Jubilant Cadista Pharmaceuticals, Inc. | UNKNOWN |
| Lannett Company, Inc. | INDUSTRY |
| Meitheal Pharmaceuticals, Inc. | INDUSTRY |
| Mylan Pharmaceuticals Inc | INDUSTRY |
| Novartis Pharmaceuticals | INDUSTRY |
| Rising Pharma Holdings, Inc. | UNKNOWN |
| RK Pharma Inc. | UNKNOWN |
| Sandoz | INDUSTRY |
| Strides Pharma, Inc | UNKNOWN |
| Teva Pharmaceuticals USA | INDUSTRY |
| TWi Pharmaceuticals, Inc. | UNKNOWN |
| VistaPharm, Inc. | INDUSTRY |
| Wuxi Fortune Pharmaceutical Co., Ltd | UNKNOWN |
| Zydus Pharmaceuticals | UNKNOWN |
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