The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency
NCT ID: NCT00301366
Last Updated: 2014-08-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
38 participants
INTERVENTIONAL
2006-06-30
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Alpha-1 Proteinase Inhibitor (Human), modified process
Study the safety and tolerability of weekly infusions of Alpha-1 Proteinase Inhibitor (Human), modified process (Alpha-1 MP, 60 mg/kg) over 20 weeks of therapy in adult Alpha-1 antitrypsin deficient subjects.
alpha-1 proteinase inhibitor (human)
60 mg/kg weekly for 20 weeks
Interventions
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alpha-1 proteinase inhibitor (human)
60 mg/kg weekly for 20 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Grifols Therapeutics LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Kim Hanna, MSc
Role: STUDY_DIRECTOR
Grifols Therapeutics LLC
Locations
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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
Countries
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References
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Wewers MD, Casolaro MA, Sellers SE, Swayze SC, McPhaul KM, Wittes JT, Crystal RG. Replacement therapy for alpha 1-antitrypsin deficiency associated with emphysema. N Engl J Med. 1987 Apr 23;316(17):1055-62. doi: 10.1056/NEJM198704233161704.
Gadek JE, Klein HG, Holland PV, Crystal RG. Replacement therapy of alpha 1-antitrypsin deficiency. Reversal of protease-antiprotease imbalance within the alveolar structures of PiZ subjects. J Clin Invest. 1981 Nov;68(5):1158-65. doi: 10.1172/jci110360.
Gadek JE, Fells GA, Zimmerman RL, Rennard SI, Crystal RG. Antielastases of the human alveolar structures. Implications for the protease-antiprotease theory of emphysema. J Clin Invest. 1981 Oct;68(4):889-98. doi: 10.1172/jci110344.
Related Links
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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
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
Other Identifiers
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11815
Identifier Type: -
Identifier Source: org_study_id
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