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The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

Multi-center, Open-label Trial to Evaluate the Safety and Tolerability of Alpha-1 MP in Subjects With Alpha-1-antitrypsin (AAT) Deficiency

NCT00301366•Grifols Therapeutics LLC

View on ClinicalTrials.gov

Summary

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

Detailed Description

The objective of this clinical trial (STAMP: Safety and Tolerability of Alpha-1 Modified Process) is to study the safety and tolerability of Alpha-1 MP in adult Alpha 1-antitrypsin deficient subjects as reported over 20 weeks of therapy. The primary objective is to describe the nature and frequency of treatment-emergent adverse events with "treatment-emergent" defined as any adverse event occurring after the start of the first study drug infusion.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Documented diagnosis of congenital Alpha1-antitrypsin deficiency
•Documented forced expiratory volume in 1 second (FEV1 ) between 20% - 80% of predicted value within last 6 months.
•Signed written informed consent prior to initiation of any study related procedures.

Exclusion Criteria

•Females who are pregnant, breast feeding, or if of child-bearing potential, unwilling to practice adequate contraception throughout the study
•Use of systemic steroids within the 2 weeks prior to receiving study treatment (this does not include the use of inhaled steroids used on a routine or as needed basis).
•Subjects who have had exacerbations of their disease within one month of trial entry

Locations (10)

National Jewish Medical and Research Center

Denver, Colorado, United States

University of Florida College of Medicine

Gainesville, Florida, United States

University of Miami School of Medicine

Miami, Florida, United States

St Lukes-Roosevelt Hospital Center, New York

New York, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Texas Health Center at Tyler

Tyler, Texas, United States

University of Cambridge - Cambridge Institute for Medical Research

Cambridge, England, United Kingdom

University Teaching Hospital of Edinburgh

Edinburgh, Scotland, United Kingdom

Key Dates

Start Date

June 1, 2006

Primary Completion Date

March 1, 2007

Completion Date

March 1, 2007

Last Updated

August 19, 2014

Enrollment

ACTUAL participants

Conditions

Alpha 1-Antitrypsin Deficiency

Interventions

alpha-1 proteinase inhibitor (human)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Efficacy of BEAM-302 in Adult Patients With Alpha-1 Antitrypsin Deficiency (AATD)

Gene Therapy for Alpha 1- Antitrypsin Deficiency

Phase III, Efficacy and Safety of "Kamada-AAT for Inhalation"

Alpha-1 Research Registry

Epigenetic Regulation of Immunity in Alpha-1 Anti-trypsin Deficiency

Functional and Structural Lung Imaging in Chronic Obstructive Pulmonary Disease