The Mycophenolate Pregnancy Registry

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• Pregnancy and reported maternal exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment

Locations
United States
Massachusetts
Quintiles Outcome
RECRUITING
Cambridge
Contact Information
Primary
Reference Study ID Number: ML22679 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: 2012-11-20
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 500
Treatments
Cohort
Sponsors
Collaborators: Endo Pharmaceuticals, Avet Lifesciences Limited, RK Pharma Inc., Biocon Pharma Limited, Sandoz, Amneal Pharmaceuticals, LLC, Ascend Laboratories, LLC, Jubilant Cadista Pharmaceuticals, Inc., Strides Pharma, Inc, VistaPharm, Inc., Lannett Company, Inc., Zydus Pharmaceuticals, Hisun Pharmaceuticals, Amta labs Limited, Teva Pharmaceuticals USA, TWi Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Novartis Pharmaceuticals, Meitheal Pharmaceuticals, Inc., Rising Pharma Holdings, Inc., Alkem Laboratories Ltd, Hetero Labs Limited, Unit-V, Mylan Pharmaceuticals Inc, Accord Healthcare, Inc., Liqmeds Worldwide Ltd, Concord Biotech Limited, Apotex Corporation, Wuxi Fortune Pharmaceutical Co., Ltd
Leads: Genentech, Inc.

This content was sourced from clinicaltrials.gov