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NCT01665326 · ClinicalTrials.gov registry record
Determination of CRIM Status and Longitudinal Follow-up of Individuals With Pompe Disease
A clinical trial of Pompe Disease, sponsored by Duke University.
- Recruiting
- Registry status
- 400
- Enrollment target
- 1
- Study location
NCT01665326 is a study of Pompe Disease that is actively recruiting participants, run by Duke University. The registered enrollment target is 400 participants, above the 204-participant average among 14 other Pompe Disease trials with a reported enrollment target (96% higher). The trial reports 1 study location across 1 state.
The verdict
NCT01665326, a study of Pompe Disease, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- 400 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a longitudinal natural history study of Infantile Pompe disease. The investigators will regularly collect and review medical information regarding the diagnosis of Pompe disease, response to enzyme replacement (ERT) using alglucosidase alfa (Lumizyme/Myozyme) and response to immunosuppressive therapy in cases at risk for developing or those who have developed high and sustained antibodies to ERT. To follow the long-term outcomes, we will collect medical records including but not limited to the diagnosis, clinical parameters, assessments for clinical monitoring, and laboratory values including antibody testing results.
Conditions Studied
Interventions
- OTHER Observational
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2009-09 |
| Est. Completion | 2029-03 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01665326
The ClinicalTrials.gov registry entry for NCT01665326 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 204-participant average among 14 other Pompe Disease trials with a reported enrollment target (96% higher). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pompe Disease appearing as the primary indexed condition, and to 1 intervention - of which Observational is the first listed.
NCT01665326 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT01665326 about?
NCT01665326 is a clinical study titled "Determination of CRIM Status and Longitudinal Follow-up of Individuals With Pompe Disease". This is a longitudinal natural history study of Infantile Pompe disease. The investigators will regularly collect and review medical information regarding the diagnosis of Pompe disease, response to enzyme replacement (ERT) using alglucosidase alfa (Lumizyme/Myozyme) and response to immunosuppressiv...
What is the current status of trial NCT01665326?
This trial is currently recruiting. The enrollment target is 400 participants. The study started on 2009-09. Estimated completion is 2029-03.
What conditions does trial NCT01665326 study?
This clinical trial studies the following conditions: Pompe Disease.
What interventions are being tested in trial NCT01665326?
The interventions under investigation include: Observational (OTHER).
Who is sponsoring clinical trial NCT01665326?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01665326 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.