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NCT02722304 · ClinicalTrials.gov registry record · Phase 3
Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency
A Phase 3 study, sponsored by Baxalta now part of Shire.
- Terminated
- Registry status
- Phase 3
- Development phase
- 7
- Enrollment target
NCT02722304: Clinical Trial Phase 3 study, sponsored by Baxalta now part of Shire.
NCT02722304 is a Phase 3 study that was terminated before completion, run by Baxalta now part of Shire. The registered enrollment target is 7 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02722304, a Phase 3 study, was terminated before completion, sponsored by Baxalta now part of Shire.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 7 participants
- Enrollment target
Study Summary
The purpose of this study is to conduct a pilot study to evaluate the safety and efficacy of weekly administration of Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy in subjects with A1PI deficiency and emphysema/ chronic obstructive pulmonary disease (COPD).
Primary Outcome
Rate of change in lung density was assessed by computed tomography (CT) densitometry. Computed Tomography (CT) scans was used to measure lung density as a quantitative assessment of emphysema progression and treatment efficacy at each of the study visits. CT lung density at the 15th percentile (PD15) is the threshold below which 15% of the voxels have lower densities, and was used as the parameter for estimating the rate of lung density decline. Rate of change in lung density based on Group 1 (A
Interventions
- BIOLOGICAL ARALAST NP 60 mg/kg
- BIOLOGICAL ARALAST NP 120 mg/kg
- BIOLOGICAL GLASSIA 60 mg/kg
- BIOLOGICAL GLASSIA 120 mg/kg
- BIOLOGICAL Human Albumin 2%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2016-11-02 |
| Est. Completion | 2018-09-14 |
| Phase | Phase 3 |
Why NCT02722304 stopped before completion
NCT02722304 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which ARALAST NP 60 mg/kg is the first listed.
NCT02722304 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02722304 about?
NCT02722304 is a clinical study titled "Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency". The purpose of this study is to conduct a pilot study to evaluate the safety and efficacy of weekly administration of Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy in subjects with A1PI deficiency and emphysema/ chronic obstructive pulmonary disease (COPD).
What is the current status of trial NCT02722304?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 7 participants. The study started on 2016-11-02. Estimated completion is 2018-09-14.
What interventions are being tested in trial NCT02722304?
The interventions under investigation include: ARALAST NP 60 mg/kg (BIOLOGICAL), ARALAST NP 120 mg/kg (BIOLOGICAL), GLASSIA 60 mg/kg (BIOLOGICAL), GLASSIA 120 mg/kg (BIOLOGICAL), Human Albumin 2% (BIOLOGICAL).
Who is sponsoring clinical trial NCT02722304?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02722304's enrollment target sits among peer trials
7 1995th of 2000 higher than 6 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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