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Sponsored by: |
Talecris Biotherapeutics |
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Information provided by: | Talecris Biotherapeutics |
ClinicalTrials.gov Identifier: | NCT00295061 |
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 |
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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. |
Enrollment: | 24 |
Study Start Date: | May 2006 |
Study Completion Date: | February 2007 |
Arms | Assigned Interventions |
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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
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Drug: alpha-1 proteinase inhibitor (human)
Alpha-1 MP
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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
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Drug: alpha-1 proteinase inhibitor (human)
Prolastin
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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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Eric Batson, MD | Talecris Biotherapeutics |
Study ID Numbers: | 11816 |
Study First Received: | February 20, 2006 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00295061 |
Health Authority: | United States: Food and Drug Administration |
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