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Completed Phase 3 Interventional Results available

Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults

ClinicalTrials.gov ID: NCT00295061

Public ClinicalTrials.gov record NCT00295061. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 5, 2026, 8:05 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Multi-center, Randomized, Double-blind, Crossover Trial to Evaluate the Pharmacokinetic Comparability of Alpha-1 MP to Prolastin in Subjects With Alpha1-antitrypsin Deficiency.

Study identification

NCT ID
NCT00295061
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Grifols Therapeutics LLC
Industry
Enrollment
24 participants

Conditions and interventions

Interventions

  • Alpha-1 MP Drug
  • alpha-1 proteinase inhibitor (human) Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2006
Primary completion
Jan 31, 2007
Completion
Jan 31, 2007
Last update posted
Sep 8, 2014

2006 – 2007

United States locations

U.S. sites
8
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
National Jewish Medical and Research Center Denver Colorado 80206
University of Florida College of Medicine Gainesville Florida 32610-0225
University of Miami School of Medicine Miami Florida 33101
St Lukes-Roosevelt Hospital Center, New York New York New York 10019
Cleveland Clinic Foundation Cleveland Ohio 44122
Temple University Hospital Philadelphia Pennsylvania 19140
Medical University of South Carolina Charleston South Carolina 29425
University of Texas Health Center at Tyler Tyler Texas 75708-3154

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00295061, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 8, 2014 · Synced May 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00295061 live on ClinicalTrials.gov.

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