The Mycophenolate Pregnancy Registry

Conditions

• Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases

Eligibility Criteria

Sex

FEMALE

Age

N/A - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

First listed

Nov 26, 2012

Start date

Nov 20, 2012

Status verified

Jul 2026

Primary completion

Dec 31, 2040

Completion

Dec 31, 2040

Study Design

Enrollment

500 participants (estimated)

Arms

• Arm: Pregnant Patients Exposed to Mycophenolate

Primary Outcome Measure

Maternal Outcomes: Incidence of Pregnancy Complications [ Time Frame: Approximately 13 years ]

Central Contacts

• Reference Study ID Number: ML22679 https://forpatients.roche.com/ No attachments to email below.
  888-662-6728 (U.S. and Canada)
  [email protected]
• Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (1)

Find similar trials in Cambridge, MA