The Mycophenolate Pregnancy Registry
Trial statusCompleted
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorGenentech, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnancy and reported maternal exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment
Disqualifiers
Pregnancies for which there is paternal exposure only
Pregnancies occurring outside the U.S.
Trial population
Pregnancy and reported exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 1 trial groupGroup A: Pregnant Patients Exposed to Mycophenolate
Trial outcomes
Primary outcomes
1
Maternal Outcomes: Incidence of Pregnancy Complications
Time frame
Approximately 13 years2
Fetal Outcomes: Incidence of Congenital Disorders
Time frame
Approximately 13 years3
Time/Duration of Mycophenolate Exposure
Time frame
Approximately 13 years4
Mycophenolate Dose/Regimen
Time frame
Approximately 13 yearsSecondary outcomes
1
Occurrence of Educational Counseling on the Increased Risks of Birth Defects With Mycophenolate Therapy
Time frame
Approximately 13 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Genentech, Inc.
Lead sponsor
Accord Healthcare, Inc.
Collaborator
Alkem Laboratories Ltd
Collaborator
Ascend Laboratories, LLC
Collaborator
Amneal Pharmaceuticals, LLC
Collaborator
Amta labs Limited
Collaborator
Apotex Inc.
Collaborator
Avet Lifesciences Limited
Collaborator
Azurity Pharmaceuticals
Collaborator
Biocon Pharma Limited
Collaborator
Concord Biotech Limited
Collaborator
Endo USA Inc., a Keenova Therapeutics Company
Collaborator
Hetero Labs Limited, Unit-V
Collaborator
Hikma Pharmaceuticals USA Inc.
Collaborator
Hisun Pharmaceuticals
Collaborator
Jubilant Cadista Pharmaceuticals, Inc.
Collaborator
Lannett Company, Inc.
Collaborator
Meitheal Pharmaceuticals, Inc.
Collaborator
Mylan Pharmaceuticals Inc
Collaborator
Novartis Pharmaceuticals
Collaborator
Rising Pharma Holdings, Inc.
Collaborator
RK Pharma Inc.
Collaborator
Sandoz
Collaborator
Strides Pharma, Inc
Collaborator
Teva Pharmaceuticals USA
Collaborator
TWi Pharmaceuticals, Inc.
Collaborator
VistaPharm, Inc.
Collaborator
Wuxi Fortune Pharmaceutical Co., Ltd
Collaborator
Zydus Pharmaceuticals
Collaborator
Source ClinicalTrials.gov
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