The Mycophenolate Pregnancy Registry
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01733082 |
Recruitment Status : Unknown
Verified November 2016 by Genentech, Inc..
Recruitment status was: Recruiting
First Posted : November 26, 2012
Last Update Posted : November 2, 2016
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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 or disease |
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Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases |
Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Mycophenolate Pregnancy Registry |
Study Start Date : | November 2012 |
Estimated Primary Completion Date : | March 2021 |
Estimated Study Completion Date : | March 2021 |
Group/Cohort |
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Cohort |
- 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 ]
- Occurrence of educational counseling on the risks of birth defects with mycophenolate therapy [ Time Frame: approximately 8 years ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733082
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 |
United States, Massachusetts | |
Recruiting | |
Cambridge, Massachusetts, United States, 02139 |
Study Director: | Clinical Trials | Genentech, Inc. |
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT01733082 |
Other Study ID Numbers: |
ML22679 |
First Posted: | November 26, 2012 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |
Autoimmune Diseases Immune System Diseases |