Pulmonary Emphysema in Alpha-1 PI Deficiency Clinical Trial in Marburg Hessen
Have you or your loved ones been diagnosed with pulmonary emphysema in alpha-1 pi deficiency?
You may be eligible to participate in a pulmonary emphysema in alpha-1 pi deficiency clinical trial.
Have you or your loved ones been diagnosed with pulmonary emphysema in alpha-1 pi deficiency? You may be eligible to participate in a pulmonary emphysema in alpha-1 pi deficiency clinical trial.
Where you'll go
Recruiting Barnaul, 656038
Recruiting Bron, Rhone, FRA 69500
Details for the study
Inclusion Criteria: - Have a documented total alpha1-PI serum level < 11 µM. - Have a diagnosis of congenital AATD with an allelic combination of ZZ, SZ, Z(null), (null)(null), S(null), or "at-risk" alleles. - At the Screening (Week -3) Visit, have a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30% and < 80% of predicted and FEV1/forced vital capacity (FVC) < 70% (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II or III). - Have a carbon monoxide diffusing capacity (DLCO) ≤ 60% of predicted (corrected for HgB) within the past 2 years OR evidence of pulmonary emphysema on CT scan within the past 2 years per the Investigator's judgment. - Have clinical evidence of pulmonary emphysema per the Investigator's judgment. Exclusion Criteria: - Has received alpha1-PI augmentation therapy for more than 1 month within the six months prior to the Screening Visit. - Has received alpha1-PI augmentation therapy within one month of the Screening Visit. - Has had a chronic obstructive pulmonary disease (COPD) exacerbation within the 5 weeks prior to the Screening Visit or during the Screening Phase. - Unable to physically (e.g., unable to fit inside the CT scanner) or mentally (e.g., claustrophobic) undergo a CT scan. - History of lung or liver transplant. - Any lung surgery during the past 2 years (excluding lung biopsy). - On the waiting list for lung surgery, including lung transplant. - Smoking during the past 12 months or a positive urine cotinine test at screening that is due to smoking. Maybe on Nicotine replacement, including vapor cigarettes. - History of anaphylaxis or severe systemic response to any plasma-derived alpha1-PI preparation or other blood product(s). - Use of systemic steroids above a stable dose equivalent to 5 mg/day prednisone (i.e., 10 mg every 2 days) within the 5 weeks prior to the Screening Visit (inhaled steroids are not considered systemic steroids) or during the Screening Phase. - Use of systemic or aerosolized antibiotics for a COPD exacerbation within the 5 weeks prior to the Screening Visit or during the Screening Phase. - Known selective or severe Immunoglobulin A (IgA) deficiency.
Interested in learning more?
Universitaetsklinikum Giessen und Marburg GmbH
Baldingerstraße, Marburg, Hessen, DEU 35043