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NCT00882921 · ClinicalTrials.gov registry record
An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients
A clinical trial, sponsored by Shire.
- Completed
- Registry status
- 26
- Enrollment target
NCT00882921: Completed study, sponsored by Shire.
NCT00882921 is a clinical trial that has completed, run by Shire. The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00882921 has completed, sponsored by Shire.
- COMPLETED
- Registry status
- 26 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the effect of anti-idursulfase antibodies on idursulfase safety (measured by infusion related adverse events) between patients who develop anti-idursulfase antibodies and patients who do not after long-term idursulfase enzyme replacement therapy (ERT).
Primary Outcome
The primary analysis of how presence of antibodies affected IRAE rates was performed based on a negative binomial regression model. This was done to account for potentially differential follow-up time between antibody groups.
Interventions
- BIOLOGICAL Idursulfase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2008-10-14 |
| Est. Completion | 2013-02-08 |
What the finished NCT00882921 record still lists
NCT00882921 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 26 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Idursulfase is the first listed.
NCT00882921 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00882921 about?
NCT00882921 is a clinical study titled "An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients". The objective of this study is to evaluate the effect of anti-idursulfase antibodies on idursulfase safety (measured by infusion related adverse events) between patients who develop anti-idursulfase antibodies and patients who do not after long-term idursulfase enzyme replacement therapy (ERT).
What is the current status of trial NCT00882921?
This trial is currently completed. The enrollment target is 26 participants. The study started on 2008-10-14. Estimated completion is 2013-02-08.
What interventions are being tested in trial NCT00882921?
The interventions under investigation include: Idursulfase (BIOLOGICAL).
Who is sponsoring clinical trial NCT00882921?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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