Clinical trial NCT01733082: The Mycophenolate Pregnancy Registry
Official title: The Mycophenolate Pregnancy Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Accord Healthcare, Inc.
name: Alkem Laboratories Ltd
name: Ascend Laboratories, LLC
name: Amneal Pharmaceuticals, LLC
name: Amta labs Limited
name: Apotex Corporation
name: Avet Lifesciences Limited
name: Biocon Pharma Limited
name: Concord Biotech Limited
name: Endo Pharmaceuticals
name: Hetero Labs Limited, Unit-V
name: Hikma Pharmaceuticals USA Inc.
name: Hisun Pharmaceuticals
name: Jubilant Cadista Pharmaceuticals, Inc.
name: Lannett Company, Inc.
name: Liqmeds Worldwide Ltd
name: Meitheal Pharmaceuticals, Inc.
name: Mylan Pharmaceuticals Inc
name: Novartis Pharmaceuticals
name: Rising Pharma Holdings, Inc.
name: RK Pharma Inc.
name: Sandoz
name: Strides Pharma, Inc
name: Teva Pharmaceuticals USA
name: TWi Pharmaceuticals, Inc.
name: VistaPharm, Inc.
name: Wuxi Fortune Pharmaceutical Co., Ltd
name: Zydus Pharmaceuticals
First posted: 2012-11-26
Enrollment: 500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnancy and reported exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment

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.


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.

Primary outcomes:
measure: Maternal Outcomes: Incidence of Pregnancy Complications
timeFrame: Approximately 13 years
measure: Fetal Outcomes: Incidence of Congenital Disorders
timeFrame: Approximately 13 years
measure: Time/Duration of Mycophenolate Exposure
timeFrame: Approximately 13 years
measure: Mycophenolate Dose/Regimen
timeFrame: Approximately 13 years
measure: Indications for Mycophenolate use
timeFrame: Approximately 13 years
measure: Maternal Medical/Demographic Characteristics
timeFrame: Approximately 13 years
Secondary outcomes:
measure: Occurrence of Educational Counseling on the Increased Risks of Birth Defects With Mycophenolate Therapy
timeFrame: Approximately 13 years
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Quintiles Outcome
state: Massachusetts
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: