Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT03385395
Eligibility Criteria:
Inclusion Criteria:
* Any subject who needs chronic IV augmentation and maintenance therapy with A1PI because of congenital alpha-1-proteinase inhibitor (A1PI) deficiency and clinically diagnosed emphysema
* ≥18 years of age
* Individuals with A1PI serum concentration \<11 µM at screening
* Following bronchodilators:
* Initial FEV1(pred) between 25% and 75% or
* If the initial FEV1 was greater than 75% of predicted, a diffusing capacity of the lung for carbon monoxide (DLC O) less than 70% of predicted
* Following bronchodilators: Initial forced expiratory volume/forced vital capacity (FEV1/FVC) ratio less than 70%
* Non-smoking for at least 6 months before study treatment starts
* Able to understand and provide written informed consent
* Women of reproductive age: negative result of pregnancy test (human chorionic gonadotropin \[HCG\]-based assay) and agreement to use adequate contraception for the duration of the trial
Exclusion Criteria:
* Any inflammatory condition or malignant tumor in the 7 days before treatment starts that according to investigator judgment might influence the metabolism of an enzyme inhibitor such as A1PI
* More than one A1PI-deficiency related exacerbation and/or hospitalization during the 3 months before study treatment starts
* Clinically significant liver or kidney disease in the preceding 6 months before study treatment starts
* Severe gas exchange abnormality (i.e., PaCO2 ≥46 mmHg)
* Known IgA deficiency with documented antibodies against IgA
* History of hypersensitivity to blood or plasma derived products, or any component of the product
* Known presence of antibodies against A1PI
* Seropositivity for HBsAg or HCV, HIV-1/2 IgG antibodies
* Administration of A1PI products in the 4 weeks before study treatment starts
* Participating in another clinical study currently or during the 3 months before study treatment starts.
* Live viral vaccination within the last month before study treatment starts
* A current life-threatening malignancy
* Emergency operation within 3 months before study treatment starts
* History of, or suspected, alcohol or drug abuse within 1 year before study treatment starts or currently on drug abuse therapy
* Pregnant and nursing women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03385395
Study Brief:
Protocol Section:
NCT03385395