The Mycophenolate Pregnancy Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Genentech, Inc.
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.
ClinicalTrials.gov Identifier:
NCT01733082
First received: November 20, 2012
Last updated: July 1, 2016
Last verified: July 2016
  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:


Further study details as provided by Genentech, Inc.:

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 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
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

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: July 1, 2016
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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2016