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NCT01176266 · ClinicalTrials.gov registry record · Phase 2
Open-Label Study of Asfotase Alfa in Infants and Children ≤ 5 Years of Age With Hypophosphatasia (HPP)
A Phase 2 study, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
NCT01176266: Completed Phase 2 study, sponsored by Alexion Pharmaceuticals.
NCT01176266 is a Phase 2 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 69 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01176266, a Phase 2 study, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
Study Summary
This clinical trial was conducted to study hypophosphatasia (HPP), a bone disorder caused by gene mutations or changes. These gene mutations cause low levels of an enzyme needed to harden bone. The purpose of this study was to test the safety and efficacy of a study drug called asfotase alfa (human recombinant tissue non-specific alkaline phosphate fusion protein) to see what effects it has on patients 5 years of age or less with HPP.
Primary Outcome
The effect of asfotase alfa treatment on skeletal manifestations of HPP (i.e., change in rickets severity) was measured by radiographs using a qualitative Radiographic Global Impression of Change (RGI-C) scale. Skeletal radiographs obtained at Week 24 were compared with skeletal radiographs obtained before initiation of treatment. The RGI-C is a 7-point rating scale that ranges from -3 (indicative of severe worsening of HPP-associated rickets) to +3 (indicative of complete or near complete heali
Interventions
- DRUG asfotase alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2010-07 |
| Est. Completion | 2016-09 |
| Phase | Phase 2 |
What the finished NCT01176266 record still lists
NCT01176266 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which asfotase alfa is the first listed.
NCT01176266 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01176266 about?
NCT01176266 is a clinical study titled "Open-Label Study of Asfotase Alfa in Infants and Children ≤ 5 Years of Age With Hypophosphatasia (HPP)". This clinical trial was conducted to study hypophosphatasia (HPP), a bone disorder caused by gene mutations or changes. These gene mutations cause low levels of an enzyme needed to harden bone. The purpose of this study was to test the safety and efficacy of a study drug called asfotase alfa (human ...
What is the current status of trial NCT01176266?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2010-07. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01176266?
The interventions under investigation include: asfotase alfa (DRUG).
Who is sponsoring clinical trial NCT01176266?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01176266's enrollment target sits among peer trials
69 965th of 2000 higher than 1,034 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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