|drug1842||Liquid Alpha1-Proteinase Inhibitor (Human) Wiki||0.71|
|drug94||ARALAST NP Wiki||0.71|
|D029424||Pulmonary Disease, Chronic Obstructive NIH||0.20|
|D008173||Lung Diseases, Obstructive NIH||0.20|
There are 2 clinical trials
The purpose of this study is to evaluate the efficacy of ARALAST NP A1PI augmentation therapy 120 milligrams per kilogram (mg/kg) body weight (BW)/week compared with an external placebo comparator on the loss of emphysematous lung tissue measured by lung density change in participants with A1PI deficiency and COPD-E.
Description: Annual rate of the physiologically adjusted lung density change will be measured as the 15th percentile of the lung density measurements (PD15) as assessed by Computed Tomography (CT) densitometry at total lung capacity (TLC). CT lung density at the 15th percentile (PD15) is the threshold below which 15 percentage (%) of the voxels have lower densities and is used as the parameter for estimating the rate of lung density decline. Annual rate of the physiologically adjusted lung density change will be tested in a fixed comparision sequence 1. ARALAST NP 120 mg/kg BW/week group versus (vs) external placebo group, 2. ARALAST NP120 mg/kg BW/week vs 60 mg/kg BW/week, 3. ARALAST NP 60 mg/kg BW/week group vs external placebo group.Measure: Annual Rate of the Physiologically Adjusted Lung Density Change Time: Baseline, up to Week 104
Description: COPD exacerbations are defined as an acute worsening of respiratory symptoms that results in additional therapy and will be assessed according to the classification in GOLD criteria (2020) as follows: Moderate (treated with short acting bronchodilators [SABDs] plus antibiotics and/or oral corticosteroids) and Severe (required hospitalizations or a visit to the emergency room).Measure: Number of Moderate or Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) Time: Baseline, up to Week 104
Description: Annual rate of change in post-bronchodilator FEV1 will be assessed.Measure: Annual Rate of Change in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Time: Baseline, up to Week 104
Description: An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this IP or medicinal product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. TEAE's will include related, serious adverse events (SAEs), suspected adverse reactions plus adverse reactions of interest, temporally-associated adverse events (AEs) with onset during infusion or within 24 hours following the end of IP infusion, and AEs resulting in changes to infusion dose.Measure: Number of Participants with Treatment-Emergent Adverse Events (TEAE's) Time: From Start of the study drug administration up to End of the study (up to Week 105)
Description: Number of participants who develop anti- A1PI antibodies following treatment with ARALAST NP will be assessed.Measure: Number of Participants Who Develop Anti-A1PI Antibodies Following Treatment With ARALAST NP Time: From Start of the study drug administration up to End of the study (up to Week 105)
Description: Plasma trough level of antigenic and functional A1PI for ARALAST NP at each dose level (ARALAST NP 60 mg/kg BW/week, ARALAST NP 120 mg/kg BW/week) will be assessed.Measure: Plasma Trough Level of Antigenic and Functional A1PI for ARALAST NP at each dose Level Time: Pre-dose, Weeks 4, 13, 28, 52, 78, 91, 104, 105
The purpose of the study is to determine if liquid alpha1-proteinase inhibitor (human) (liquid alpha1-PI) plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29 versus placebo plus SMT in hospitalized participants with COVID-19.
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports