Actively Recruiting

FEMALE
NCT01733082

The Mycophenolate Pregnancy Registry

Led by Genentech, Inc. · Updated on 2026-05-14

500

Participants Needed

1

Research Sites

1466 weeks

Total Duration

On this page

Sponsors

G

Genentech, Inc.

Lead Sponsor

A

Accord Healthcare, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Mycophenolate Pregnancy Registry

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnancy and reported maternal exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment
Not Eligible

You will not qualify if you...

  • Pregnancies with only paternal exposure to mycophenolate
  • Pregnancies occurring outside the United States

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Quintiles Outcome

Cambridge, Massachusetts, United States, 02139

Actively Recruiting

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Research Team

R

Reference Study ID Number: ML22679 https://forpatients.roche.com/

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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