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NCT01205152 · ClinicalTrials.gov registry record · Phase 2
Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)
A Phase 2 study of Hypophosphatasia, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 8
- Study locations
NCT01205152: Completed Phase 2 study of Hypophosphatasia, sponsored by Alexion Pharmaceuticals.
NCT01205152 is a Phase 2 study of Hypophosphatasia that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 10 participants, below the 82-participant average among 6 other Hypophosphatasia trials with a reported enrollment target (88% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01205152, a Phase 2 study of Hypophosphatasia, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 8
- Study locations
Study Summary
This clinical trial studied the long term safety and efficacy of asfotase alfa in infants and young children with infantile onset HPP who completed study ENB-002-08 (NCT00744042). Partial funding for this study was provided by the Office of Orphan Product Development (OOPD).
Primary Outcome
Outcome measure is the number of patients with 1 or more treatment-emergent adverse event. The time period is from Baseline in the ENB-003-08 study to the end of the ENB-003-08 study.
Conditions Studied
Interventions
- BIOLOGICAL asfotase alfa
Study Locations (8)
Delaware
- Alfred I. DuPont Hospital for Children - Wilmington
Missouri
- St. John's Medical Research Institute - Springfield
Nebraska
- University of Nebraska Medical Center - Omaha
Tennessee
- Vanderbilt University Medical Center - Nashville
Wisconsin
- St. Vincent Hospital - Green Bay
Abu Dhabi Emirate
- Tawam Hospital - Al Ain City
Northern Ireland
- Royal Maternity Hospital, Royal Belfast Hospital for Sick Children - Belfast
Other
- Sheffield Children's Hospital - Sheffield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2009-04 |
| Est. Completion | 2016-08 |
| Phase | Phase 2 |
What the finished NCT01205152 record still lists
NCT01205152 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 82-participant average among 6 other Hypophosphatasia trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Hypophosphatasia appearing as the primary indexed condition, and to 1 intervention - of which asfotase alfa is the first listed.
NCT01205152 lists 8 locations in 8 states (Delaware, Missouri, Nebraska).
Frequently Asked Questions
What is clinical trial NCT01205152 about?
NCT01205152 is a clinical study titled "Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)". This clinical trial studied the long term safety and efficacy of asfotase alfa in infants and young children with infantile onset HPP who completed study ENB-002-08 (NCT00744042). Partial funding for this study was provided by the Office of Orphan Product Development (OOPD).
What is the current status of trial NCT01205152?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2009-04. Estimated completion is 2016-08.
What conditions does trial NCT01205152 study?
This clinical trial studies the following conditions: Hypophosphatasia.
What interventions are being tested in trial NCT01205152?
The interventions under investigation include: asfotase alfa (BIOLOGICAL).
Who is sponsoring clinical trial NCT01205152?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01205152 being conducted?
This trial has 8 study locations across Delaware, Missouri, Nebraska, Tennessee, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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-
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