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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 is a Phase 3 study that was terminated before completion, run by Baxalta now part of Shire. The registered enrollment target is 7 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02722304
The ClinicalTrials.gov registry entry for NCT02722304 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which ARALAST NP 60 mg/kg is the first listed.
NCT02722304 reports 0 study locations.
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.
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