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NCT00301366 · ClinicalTrials.gov registry record · Phase 3

The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency

A Phase 3 study of Alpha-1 Antitrypsin Deficiency, sponsored by Grifols Therapeutics.

Completed
Registry status
Phase 3
Development phase
38
Enrollment target
10
Study locations

NCT00301366 is a Phase 3 study of Alpha-1 Antitrypsin Deficiency that has completed, run by Grifols Therapeutics. The registered enrollment target is 38 participants, below the 3,076-participant average among 18 other Alpha-1 Antitrypsin Deficiency trials with a reported enrollment target (99% lower). The trial reports 10 study locations across 9 states.

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The verdict

NCT00301366, a Phase 3 study of Alpha-1 Antitrypsin Deficiency, has completed, sponsored by Grifols Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
38 participants
Enrollment target
10
Study locations

Study Summary

The purpose of this clinical study is to assess the safety and tolerability of Alpha-1 MP in adult Alpha1-antitrypsin deficient patients.

Conditions Studied

Alpha-1 Antitrypsin Deficiency

Interventions

  • DRUG alpha-1 proteinase inhibitor (human)

Study Locations (10)

Florida

  • University of Florida College of Medicine - Gainesville
  • University of Miami School of Medicine - Miami

Colorado

  • National Jewish Medical and Research Center - Denver

New York

  • St Lukes-Roosevelt Hospital Center, New York - New York

Ohio

  • Cleveland Clinic Foundation - Cleveland

Pennsylvania

  • Temple University Hospital - Philadelphia

South Carolina

  • Medical University of South Carolina - Charleston

Texas

  • University of Texas Health Center at Tyler - Tyler

England

  • University of Cambridge - Cambridge Institute for Medical Research - Cambridge

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2006-06
Est. Completion 2007-03
Phase Phase 3

Sponsor

Grifols Therapeutics

34 total trials

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What the Registry Record Tells You About NCT00301366

The ClinicalTrials.gov registry entry for NCT00301366 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,076-participant average among 18 other Alpha-1 Antitrypsin Deficiency trials with a reported enrollment target (99% lower). The listed sponsor is Grifols Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alpha-1 Antitrypsin Deficiency appearing as the primary indexed condition, and to 1 intervention - of which alpha-1 proteinase inhibitor (human) is the first listed.

NCT00301366 reports 10 study locations spanning 9 distinct geographic areas - top geographies include Florida, Colorado, New York.

Frequently Asked Questions

What is clinical trial NCT00301366 about?

NCT00301366 is a clinical study titled "The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency". The purpose of this clinical study is to assess the safety and tolerability of Alpha-1 MP in adult Alpha1-antitrypsin deficient patients.

What is the current status of trial NCT00301366?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 38 participants. The study started on 2006-06. Estimated completion is 2007-03.

What conditions does trial NCT00301366 study?

This clinical trial studies the following conditions: Alpha-1 Antitrypsin Deficiency.

What interventions are being tested in trial NCT00301366?

The interventions under investigation include: alpha-1 proteinase inhibitor (human) (DRUG).

Who is sponsoring clinical trial NCT00301366?

This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00301366 being conducted?

This trial has 10 study locations across Colorado, Florida, New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.