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The Mycophenolate Pregnancy Registry

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ClinicalTrials.gov Identifier: NCT01733082
Recruitment Status : 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.

Tracking Information
First Submitted Date November 20, 2012
First Posted Date November 26, 2012
Last Update Posted Date November 2, 2016
Study Start Date November 2012
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 23, 2012)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 23, 2012)
Occurrence of educational counseling on the risks of birth defects with mycophenolate therapy [ Time Frame: approximately 8 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Mycophenolate Pregnancy Registry
Official Title The Mycophenolate Pregnancy Registry
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Pregnancy and reported exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment
Condition Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases
Intervention Not Provided
Study Groups/Cohorts Cohort
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 23, 2012)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
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
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01733082
Other Study ID Numbers ML22679
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Genentech, Inc.
Study 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
Investigators
Study Director: Clinical Trials Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date November 2016