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NCT02095015 · ClinicalTrials.gov registry record
Mucopolysaccharidosis (MPS) I, II, and VI Screening in a High-Risk Population With Previous Surgical Repair or Presence of Inguinal and/or Umbilical Hernia in Combination With Pediatric ENT Surgery (The HATT Project)
A clinical trial, sponsored by Shire.
- Terminated
- Registry status
- 159
- Enrollment target
NCT02095015: Clinical Trial study, sponsored by Shire.
NCT02095015 is a clinical trial that was terminated before completion, run by Shire. The registered enrollment target is 159 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02095015 was terminated before completion, sponsored by Shire.
- TERMINATED
- Registry status
- 159 participants
- Enrollment target
Study Summary
Mucopolysaccharidosis (MPS) type II (MPS II; Hunter syndrome) is a rare, X-linked disease caused by a deficiency of the lysosomal enzyme iduronate-2-sulfatase (I2S) and occurs almost exclusively in boys, with an incidence of approximately 1.3 per 100,000 live male births.1 Early identification of MPS II is challenging because some initial features, such as chronic runny nose, otitis media, and hernias, are commonly seen in the general population. As a result, even though the signs and symptoms of MPS II typically appear early in childhood, the diagnosis may lag behind by several years. The primary objective of this international multi-center study is to evaluate the positive screening rate of MPS II subjects by screening a high-risk male pediatric population who have had or are scheduled for 1 or more specific ENT surgical procedures (adenoidectomy and/or tonsillectomy and/or tympanostomy) and who have a previously repaired or present evidence of an inguinal and/or umbilical hernia.
Primary Outcome
To evaluate the positive screening rate of MPS II subjects by screening a high risk male pediatric population.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2014-05-21 |
| Est. Completion | 2015-08-14 |
Why NCT02095015 stopped before completion
NCT02095015 is an observational study that tracks outcomes without assigning an intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02095015 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02095015 about?
NCT02095015 is a clinical study titled "Mucopolysaccharidosis (MPS) I, II, and VI Screening in a High-Risk Population With Previous Surgical Repair or Presence of Inguinal and/or Umbilical Hernia in Combination With Pediatric ENT Surgery (The HATT Project)". Mucopolysaccharidosis (MPS) type II (MPS II; Hunter syndrome) is a rare, X-linked disease caused by a deficiency of the lysosomal enzyme iduronate-2-sulfatase (I2S) and occurs almost exclusively in boys, with an incidence of approximately 1.3 per 100,000 live male births.1 Early identification of MP...
What is the current status of trial NCT02095015?
This trial is currently terminated. The enrollment target is 159 participants. The study started on 2014-05-21. Estimated completion is 2015-08-14.
Who is sponsoring clinical trial NCT02095015?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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