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NCT02282527 · ClinicalTrials.gov registry record · Phase 2

A Study to Assess Safety and PK of Liquid Alpha₁-Proteinase Inhibitor (Human) in Treating Alpha₁-Antitrypsin Deficiency

A Phase 2 study, sponsored by Grifols Therapeutics.

Completed
Registry status
Phase 2
Development phase
32
Enrollment target

NCT02282527 is a Phase 2 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 32 participants.

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The verdict

NCT02282527, a Phase 2 study, has completed, sponsored by Grifols Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
32 participants
Enrollment target

Study Summary

Grifols Therapeutics Inc. conducted a multi-center, randomized, double-blind, crossover study to evaluate the safety, immunogenicity, and pharmacokinetics (PK) of Liquid Alpha₁-PI compared to the currently licensed product, Prolastin-C, in subjects with Alpha₁-Antitrypsin Deficiency (AATD).

Interventions

  • BIOLOGICAL Liquid Alpha₁-PI
  • BIOLOGICAL Prolastin-C

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2014-10
Est. Completion 2016-01
Phase Phase 2

Sponsor

Grifols Therapeutics

34 total trials

What the Registry Record Tells You About NCT02282527

The ClinicalTrials.gov registry entry for NCT02282527 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grifols Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Liquid Alpha₁-PI is the first listed.

NCT02282527 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02282527 about?

NCT02282527 is a clinical study titled "A Study to Assess Safety and PK of Liquid Alpha₁-Proteinase Inhibitor (Human) in Treating Alpha₁-Antitrypsin Deficiency". Grifols Therapeutics Inc. conducted a multi-center, randomized, double-blind, crossover study to evaluate the safety, immunogenicity, and pharmacokinetics (PK) of Liquid Alpha₁-PI compared to the currently licensed product, Prolastin-C, in subjects with Alpha₁-Antitrypsin Deficiency (AATD).

What is the current status of trial NCT02282527?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2014-10. Estimated completion is 2016-01.

What interventions are being tested in trial NCT02282527?

The interventions under investigation include: Liquid Alpha₁-PI (BIOLOGICAL), Prolastin-C (BIOLOGICAL).

Who is sponsoring clinical trial NCT02282527?

This trial is sponsored by Grifols Therapeutics, which has 34 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.