The Comparison of the Pharmacokinetic, Safety and Tolerability of Alpha-1 MP and Prolastin In Adult Alpha1-Antitrypsin Deficient Patients - Full Text View

Sponsor:	Talecris Biotherapeutics
Information provided by:	Talecris Biotherapeutics
ClinicalTrials.gov Identifier:	NCT00295061

Purpose

The purpose of this clinical study (ChAMP - Comparability pharmacokinetics of Alpha-1 Modified Process) is to compare the pharmacokinetic, safety and tolerability of Alpha-1 Proteinase Inhibitor (Human), modified process (Alpha-1 MP) and Prolastin in adult Alpha1-antitrypsin deficient patients. Patients will be infused intravenously with study drug on a weekly schedule for 24 weeks.

Condition	Intervention	Phase
Alpha 1-Antitrypsin Deficiency	Drug: alpha-1 proteinase inhibitor (human)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Pharmacokinetics Study
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.

Resource links provided by NLM:

Genetics Home Reference related topics: alpha-1 antitrypsin deficiency

MedlinePlus related topics: Alpha-1 Antitrypsin Deficiency

U.S. FDA Resources

Further study details as provided by Talecris Biotherapeutics:

Primary Outcome Measures:

AUC [ Time Frame: 7 Days ]

Secondary Outcome Measures:

Standard pharmacokinetic parameters [ Time Frame: 7 Days ]

Enrollment:	24
Study Start Date:	May 2006
Study Completion Date:	February 2007

Arms	Assigned Interventions
1 Alpha-1 MP: Experimental Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparitor), followed by open-label Alpha-1 MP	Drug: alpha-1 proteinase inhibitor (human) Alpha-1 MP
2 Prolastin: Active Comparator Sequential, blinded treatment periods of Prolastin (active comparitor), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP	Drug: alpha-1 proteinase inhibitor (human) Prolastin

Detailed Description:

The objective of this study is to demonstrate the pharmacokinetic comparability of Alpha-1 MP to Prolastin® in subjects with Alpha1-antitrypsin deficiency.

This study is divided into three 8-week treatment sequences including an initial 8-week double-blind treatment period (with one of the 2 study drugs), a second 8-week double-blind treatment period (with the other study drug), and a third 8-week open-label treatment period (with Alpha-1 MP).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented diagnosis of congenital Alpha1-antitrypsin deficiency
Must be receiving augmentation therapy with plasma-derived (human) Alpha1-Proteinase Inhibitor (Prolastin®) for at least one month prior to study entry.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295061

Locations

United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
United States, Florida
University of Florida College of Medicine
Gainesville, Florida, United States, 32610-0225
University of Miami School of Medicine
Miami, Florida, United States, 33101
United States, New York
St Lukes-Roosevelt Hospital Center, New York
New York, New York, United States, 10019
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44122
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
University of Texas Health Center at Tyler
Tyler, Texas, United States, 75708-3154

Sponsors and Collaborators

Talecris Biotherapeutics

Investigators

Study Director:

Eric Batson, MD

Talecris Biotherapeutics

More Information

Additional Information:

The "Alpha-1 Foundation", dedicated to providing the leadership and resources that will result in increased research, improved health, worldwide detection and a cure for Alpha-1 Antitrypsin Deficiency This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

AlphaNet, Inc devoted to improving the lives of individuals with Alpha-1 antitrypsin deficiency through comprehensive disease management services, clinical research administration, and consultative services This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	11816
Study First Received:	February 20, 2006
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00295061 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Talecris Biotherapeutics:

alpha 1-Antitrypsin Deficiency
alpha 1-Antitrypsin
pulmonary emphysema

Additional relevant MeSH terms:

Serine Proteinase Inhibitors
Protein C Inhibitor
Alpha 1-Antitrypsin
Molecular Mechanisms of Pharmacological Action
Alpha 1-Antitrypsin Deficiency

Trypsin Inhibitors
Connective Tissue Diseases
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010