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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: Recruiting study of Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases, sponsored by Genentech.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Conditions Studied
Study Locations (1)
Massachusetts
- Quintiles Outcome - Cambridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2012-11-20 |
| Est. Completion | 2040-12-31 |
What NCT01733082 shows while recruiting
NCT01733082 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap.
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 a single indexed study location in 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.
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