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Recruiting No phase listed Observational

The Mycophenolate Pregnancy Registry

ClinicalTrials.gov ID: NCT01733082

Public ClinicalTrials.gov record NCT01733082. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 20, 2026, 2:28 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01733082
Recruitment status
Recruiting
Study type
Observational
Phase
Not listed
Lead sponsor
Genentech, Inc.
Industry
Enrollment
500 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 19, 2012
Primary completion
Dec 30, 2040
Completion
Dec 30, 2040
Last update posted
Sep 7, 2026

2012 – 2040

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Quintiles Outcome Cambridge Massachusetts 02139 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01733082, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 7, 2026 · Synced Sep 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01733082 live on ClinicalTrials.gov.

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