Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Grifols Therapeutics LLC
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Be between 18 and 70 years of age, inclusive
Had a diagnosis of congenital AATD
Had a documented total alpha₁-PI level \< 11 µM. If the total alpha₁-PI level had yet to be documented, a blood draw for total alpha₁-PI level was obtained at the Screening Visit
Had a post-bronchodilator Forced expiratory volume in 1 second (FEV1) ≥ 30% and \< 80% of predicted and FEV1/forced vital capacity (FVC) \< 70%
If the subject had received alpha₁-PI augmentation therapy of any kind, he/she must have been be willing to discontinue that treatment at the Week 1 (Baseline) Visit and remain off any kind of alpha₁-PI treatment, other than the investigational products for this study, while participating in the study
You may not be if
Subject had a moderate or severe pulmonary exacerbation during the 4 weeks before the Week 1 (Baseline) Visit
History of lung or liver transplant
Any lung surgery during the past 2 years (excluding lung biopsy)
Liver cirrhosis confirmed by biopsy
Elevated liver enzymes (aspartate transaminase \[AST\], alanine aminotransferase \[ALT\], and alkaline phosphatase \[ALP\]) equal to or greater than 2.5 times the upper limit of normal
Severe concomitant disease (e.g., congestive heart failure, clinically significant pulmonary fibrosis, malignant disease \[with the exception of skin cancers other than melanoma\], history of acute hypersensitivity pneumonitis reaction, or current chronic hypersensitivity pneumonitis)
Females who were pregnant, breastfeeding or, if of child-bearing potential, unwilling to practice a highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or abstinence) throughout the study
Known previous infection with or clinical signs and symptoms consistent with current hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
Smoking during the past 6 months or a positive urine cotinine test at the Screening Visit that is due to smoking
Participation in another investigational drug study within one month prior to the Week 1 (Baseline) Visit
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 4 weeks prior to the Week 1 (Baseline) Visit inhaled steroids are not considered systemic steroids)
Use of systemic or aerosolized antibiotics for an exacerbation within the 4 weeks prior to the Week 1 (Baseline) Visit
Known selective or severe Immunoglobulin A (IgA) deficiency
Clareo Health | A Study to Assess Safety and PK of Liquid Alpha₁-Proteinase Inhibitor (Human) in Treating Alpha₁-Antitrypsin Deficiency
