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The Mycophenolate Pregnancy Registry

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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
Sponsor:
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.

Study Description
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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.


Condition or disease
Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases

Study Design
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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
Groups and Cohorts
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Group/Cohort
Cohort


Outcome Measures
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Primary Outcome Measures :
  1. Maternal outcomes: Incidence of pregnancy complications [ Time Frame: approximately 8 years ]
  2. Fetal outcomes: Incidence of congenital disorders [ Time Frame: approximately 8 years ]
  3. Time/duration of mycophenolate exposure [ Time Frame: approximately 8 years ]
  4. Mycophenolate dose/regimen [ Time Frame: approximately 8 years ]
  5. Indications for mycophenolate use [ Time Frame: approximately 8 years ]
  6. Maternal medical/demographic characteristics [ Time Frame: approximately 8 years ]

Secondary Outcome Measures :
  1. Occurrence of educational counseling on the risks of birth defects with mycophenolate therapy [ Time Frame: approximately 8 years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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
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Information from the National Library of Medicine

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


Contacts
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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
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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
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Study Director: Clinical Trials Genentech, Inc.
More Information
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Additional Information:

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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
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases