The Safety and Tolerability of Alpha-1 MP in Subjects With Alpha-1-Antitrypsin (AAT) Deficiency.
Information source: Talecris Biotherapeutics
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alpha 1-Antitrypsin Deficiency
Intervention: alpha-1 proteinase inhibitor (human) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Talecris Biotherapeutics
Summary
The purpose of this clinical study is to assess the safety and tolerability of Alpha-1 MP in
adult Alpha1-antitrypsin deficient patients.
Clinical Details
Official title: Multi-Center, Open-Label Trial to Evaluate the Safety and Tolerability of Alpha-1 MP in Subjects With Alpha-1-Antitrypsin (AAT) Deficiency
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: treatment-emergent adverse events
Secondary outcome: all adverse eventsLaboratory data outside normal range
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Documented diagnosis of congenital Alpha1-antitrypsin deficiency
- Documented 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 and Contacts
Uniwersytetu Medycznego w Lodzi, Klinika Pneumonologii i Alergologii, Lodz 90 - 153, Poland
National Jewish Medical and Research Center, Denver, Colorado 80206, United States
University of Cambridge - Cambridge Institute for Medical Research, Cambridge, England CB2 2XY, United Kingdom
University of Florida College of Medicine, Gainesville, Florida 32610-0225, United States
University of Miami School of Medicine, Miami, Florida 33101, United States
St Lukes-Roosevelt Hospital Center, New York, New York, New York 10019, United States
Cleveland Clinic Foundation, Cleveland, Ohio 44122, United States
Temple University Hospital, Philadelphia, Pennsylvania 19140, United States
University Teaching Hospital of Edinburgh, Edinburgh, Scotland EH8 9AG, United Kingdom
Medical University of South Carolina, Charleston, South Carolina 29425, United States
University of Texas Health Center at Tyler, Tyler, Texas 75708-3154, United States
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 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
Related publications: 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. 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. 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.
Starting date: May 2006
Ending date: March 2007
Last updated: September 27, 2007
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