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NCT00342862 · ClinicalTrials.gov registry record
AMEVIVE® Pregnancy Registry
A clinical trial, sponsored by Astellas Pharma.
- Terminated
- Registry status
- 3
- Enrollment target
NCT00342862: Clinical Trial study, sponsored by Astellas Pharma.
NCT00342862 is a clinical trial that was terminated before completion, run by Astellas Pharma. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00342862 was terminated before completion, sponsored by Astellas Pharma.
- TERMINATED
- Registry status
- 3 participants
- Enrollment target
Study Summary
This is an observational, exposure-registration and follow-up study, to be conducted in the United States (US). The AMEVIVE® Pregnancy Exposure Registry is designed to monitor pregnant subjects and fetuses exposed to AMEVIVE® in order to detect any potential increase in the risk of major birth defects. The AMEVIVE® Pregnancy Exposure Registry is sponsored by Astellas Pharma Global Development and will be managed by INC Research. The Registry will be monitored by an independent Advisory Committee of external experts in relevant specialties of teratology, epidemiology, maternal and fetal medicine, and infectious disease medicine (external member details available upon request).
Interventions
- DRUG Amevive exposure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2003-12 |
| Est. Completion | 2011-12 |
Why NCT00342862 stopped before completion
NCT00342862 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 3 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Amevive exposure is the first listed.
NCT00342862 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00342862 about?
NCT00342862 is a clinical study titled "AMEVIVE® Pregnancy Registry". This is an observational, exposure-registration and follow-up study, to be conducted in the United States (US). The AMEVIVE® Pregnancy Exposure Registry is designed to monitor pregnant subjects and fetuses exposed to AMEVIVE® in order to detect any potential increase in the risk of major birth defec...
What is the current status of trial NCT00342862?
This trial is currently terminated. The enrollment target is 3 participants. The study started on 2003-12. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00342862?
The interventions under investigation include: Amevive exposure (DRUG).
Who is sponsoring clinical trial NCT00342862?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
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