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NCT01733082 · ClinicalTrials.gov registry record

The Mycophenolate Pregnancy Registry

A clinical trial of Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases, sponsored by Genentech.

Recruiting
Registry status
500
Enrollment target
1
Study location

NCT01733082 is a study of Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases that is actively recruiting participants, run by Genentech. The registered enrollment target is 500 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT01733082, a study of Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases, is actively recruiting participants, sponsored by Genentech.

RECRUITING
Registry status
500 participants
Enrollment target
1
Study location

Study 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.

Study Locations (1)

Massachusetts

  • Quintiles Outcome - Cambridge

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2012-11-20
Est. Completion 2040-12-31

Sponsor

Genentech

332 total trials

What the Registry Record Tells You About NCT01733082

The ClinicalTrials.gov registry entry for NCT01733082 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases appearing as the primary indexed condition, and to 0 interventions.

NCT01733082 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01733082 about?

NCT01733082 is a clinical study titled "The Mycophenolate Pregnancy Registry". 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 gestati...

What is the current status of trial NCT01733082?

This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2012-11-20. Estimated completion is 2040-12-31.

What conditions does trial NCT01733082 study?

This clinical trial studies the following conditions: Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases.

Who is sponsoring clinical trial NCT01733082?

This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01733082 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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