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Sponsored by: |
Talecris Biotherapeutics |
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Information provided by: | Talecris Biotherapeutics |
ClinicalTrials.gov Identifier: | NCT00263887 |
The goal of this trial was to explore the utility of evaluating emphysema progression through CT scans measuring lung density during a 2 year period of weekly infusions of either placebo or human alpha-1-antitrypsin (AAT; Prolastin®). Exacerbation data recorded in patient diaries were also collected. All efficacy data were analyzed for potential use in evaluating Prolastin efficacy in this and other clinical trials.
Condition | Intervention | Phase |
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Alpha 1-Antitrypsin Deficiency |
Drug: Alpha1-Proteinase Inhibitor (Human) Drug: Albumin (Human) 20%, USP |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Multi-Center, Randomized Trial With I.V. Prolastin® to Evaluate Frequency of Exacerbations and Progression of Emphysema by Means of Multi-Slice CT Scans in Patients With Congenital Alpha-1-Antitrypsin Deficiency. |
Enrollment: | 77 |
Study Start Date: | December 2003 |
Study Completion Date: | January 2007 |
Arms | Assigned Interventions |
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Group 1: Experimental
Prolastin
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Drug: Alpha1-Proteinase Inhibitor (Human)
Weekly infusion of 60 mg/kg body weight for 2 years
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Group 2: Placebo Comparator |
Drug: Albumin (Human) 20%, USP
Weekly infusion for 2 years. Albumin (Human) 20% will be diluted with 5% glucose to a final concentration of 2.0%.
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This is a one to one randomized, placebo-controlled, clinical, exploratory study with the aim of collecting information on possible clinical endpoints i.e., the progression of emphysema by lung density measurements with CT scan and frequency of exacerbations that could be used for a subsequent placebo controlled clinical trial. Progression of disease will be investigated in 80 patients with alpha-1-antitrypsin deficiency, who will be treated with human alpha-1-antitrypsin (AAT; Prolastin®) or placebo weekly for two years to analyze the effect of treatment on lung density and exacerbations. Targeted augmentation therapy with weekly infusions of Prolastin® will be a dose of 60 mg/kg body weight (range of 51.72 to 71.43 mg per kg body weight).
Therefore, this study focuses on several questions:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Gentofte Hospital Department of Respiratory Medicine | |
Hellerup, Denmark, 2900 | |
Sweden | |
Department of Pulmonary Medicine, Malmö University Hospital | |
Malmö, Sweden | |
United Kingdom, England | |
Queen Elizabeth Hospital | |
Birmingham, England, United Kingdom, B15 2TH |
Principal Investigator: | Asger Dirksen, MD PHD | University of Copenhagen |
Study ID Numbers: | 100533 |
Study First Received: | September 12, 2005 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00263887 |
Health Authority: | Denmark: Danish Medicines Agency; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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