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The Mycophenolate Pregnancy Registry

This study is currently recruiting participants.
Verified November 2012 by Genentech
Sponsor:
Collaborators:
Accord Healthcare, Inc.
Alkem Laboratories, Ltd.
Apotex Corporation
Mylan Pharmaceuticals
Novartis Pharmaceuticals
Pfizer
Roxane Laboratories
Sandoz Inc.
Teva Pharmaceuticals USA
Vintage Pharmaceuticals, LLC
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01733082
First received: November 20, 2012
Last updated: November 23, 2012
Last verified: November 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Maternal outcomes: Incidence of pregnancy complications [ Time Frame: approximately 8 years ] [ Designated as safety issue: Yes ]
  • Fetal outcomes: Incidence of congenital disorders [ Time Frame: approximately 8 years ] [ Designated as safety issue: Yes ]
  • Time/duration of mycophenolate exposure [ Time Frame: approximately 8 years ] [ Designated as safety issue: No ]
  • Mycophenolate dose/regimen [ Time Frame: approximately 8 years ] [ Designated as safety issue: No ]
  • Indications for mycophenolate use [ Time Frame: approximately 8 years ] [ Designated as safety issue: No ]
  • Maternal medical/demographic characteristics [ Time Frame: approximately 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of educational counseling on the risks of birth defects with mycophenolate therapy [ Time Frame: approximately 8 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

  Eligibility

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733082

Contacts
Contact: Please reference Study ID Number: ML22679 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
United States, Massachusetts
Recruiting
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Genentech
Accord Healthcare, Inc.
Alkem Laboratories, Ltd.
Apotex Corporation
Mylan Pharmaceuticals
Novartis Pharmaceuticals
Pfizer
Roxane Laboratories
Sandoz Inc.
Teva Pharmaceuticals USA
Vintage Pharmaceuticals, LLC
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01733082     History of Changes
Other Study ID Numbers: ML22679
Study First Received: November 20, 2012
Last Updated: November 23, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013