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The Mycophenolate Pregnancy Registry
This study is currently recruiting participants.
Verified November 2016 by Genentech, Inc.
Sponsor:
Genentech, Inc.
Collaborators:
Accord Healthcare, Inc.
Sandoz
Apotex Corporation
Novartis Pharmaceuticals
Pfizer
Mylan Pharmaceuticals
Teva Pharmaceuticals USA
Alkem Laboratories Ltd
Roxane Laboratories
Vintage Pharmaceuticals, LLC
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01733082
First received: November 20, 2012
Last updated: November 1, 2016
Last verified: November 2016
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Purpose
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.
| Condition |
|---|
| Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Mycophenolate Pregnancy Registry |
Resource links provided by NLM:
Drug Information available for:
Mycophenolic acid
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
U.S. FDA Resources
Further study details as provided by Genentech, Inc.:
Primary Outcome Measures:
- Maternal outcomes: Incidence of pregnancy complications [ Time Frame: approximately 8 years ]
- Fetal outcomes: Incidence of congenital disorders [ Time Frame: approximately 8 years ]
- Time/duration of mycophenolate exposure [ Time Frame: approximately 8 years ]
- Mycophenolate dose/regimen [ Time Frame: approximately 8 years ]
- Indications for mycophenolate use [ Time Frame: approximately 8 years ]
- Maternal medical/demographic characteristics [ Time Frame: approximately 8 years ]
Secondary Outcome Measures:
- Occurrence of educational counseling on the risks of birth defects with mycophenolate therapy [ Time Frame: approximately 8 years ]
| Estimated Enrollment: | 500 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | March 2021 |
| Estimated Primary Completion Date: | March 2021 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Pregnancy and reported exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733082
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733082
Contacts
| Contact: Reference Study ID Number: ML22679 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. and Canada) | global.rochegenentechtrials@roche.com |
Locations
| United States, Massachusetts | |
| Recruiting | |
| Cambridge, Massachusetts, United States, 02139 | |
Sponsors and Collaborators
Genentech, Inc.
Accord Healthcare, Inc.
Sandoz
Apotex Corporation
Novartis Pharmaceuticals
Pfizer
Mylan Pharmaceuticals
Teva Pharmaceuticals USA
Alkem Laboratories Ltd
Roxane Laboratories
Vintage Pharmaceuticals, LLC
Investigators
| Study Director: | Clinical Trials | Genentech, Inc. |
More Information
| Responsible Party: | Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT01733082 History of Changes |
| Other Study ID Numbers: |
ML22679 |
| Study First Received: | November 20, 2012 |
| Last Updated: | November 1, 2016 |
Additional relevant MeSH terms:
|
Autoimmune Diseases Immune System Diseases Mycophenolic Acid Mycophenolate mofetil Antibiotics, Antineoplastic Antineoplastic Agents |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017