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NCT01651351 · ClinicalTrials.gov registry record · Phase 4

GLASSIA Infusion Rate Study

A Phase 4 study, sponsored by Baxalta now part of Shire.

Completed
Registry status
Phase 4
Development phase
30
Enrollment target

NCT01651351 is a Phase 4 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 30 participants.

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The verdict

NCT01651351, a Phase 4 study, has completed, sponsored by Baxalta now part of Shire.

COMPLETED
Registry status
Phase 4
Development phase
30 participants
Enrollment target

Study Summary

The purpose of this study was to generate sufficient safety and tolerability information in support of an increase in the infusion rate of intravenous GLASSIA in the prescribing information from 0.04 to 0.2 mL/kg/min.

Interventions

  • BIOLOGICAL Alpha1-proteinase inhibitor
  • BIOLOGICAL Placebo: Human albumin 2.5%

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2012-07-31
Est. Completion 2013-01-16
Phase Phase 4

Sponsor

Baxalta now part of Shire

74 total trials

What the Registry Record Tells You About NCT01651351

The ClinicalTrials.gov registry entry for NCT01651351 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 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 2 interventions - of which Alpha1-proteinase inhibitor is the first listed.

NCT01651351 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01651351 about?

NCT01651351 is a clinical study titled "GLASSIA Infusion Rate Study". The purpose of this study was to generate sufficient safety and tolerability information in support of an increase in the infusion rate of intravenous GLASSIA in the prescribing information from 0.04 to 0.2 mL/kg/min.

What is the current status of trial NCT01651351?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2012-07-31. Estimated completion is 2013-01-16.

What interventions are being tested in trial NCT01651351?

The interventions under investigation include: Alpha1-proteinase inhibitor (BIOLOGICAL), Placebo: Human albumin 2.5% (BIOLOGICAL).

Who is sponsoring clinical trial NCT01651351?

This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.