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D019896: Alpha 1-Antitrypsin Deficiency

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (7)


Name (Synonyms) Correlation
drug500 BI 706321 Wiki 0.71
drug127 ARALAST NP Wiki 0.71
drug2351 Liquid Alpha1-Proteinase Inhibitor (Human) Wiki 0.71
Name (Synonyms) Correlation
drug499 BI 474121 Wiki 0.50
drug2615 Midazolam Wiki 0.32
drug4080 Standard Medical Treatment Wiki 0.32
drug3195 Placebo Wiki 0.06

Correlated MeSH Terms (4)


Name (Synonyms) Correlation
D004646 Emphysema NIH 0.50
D008173 Lung Diseases, Obstructive NIH 0.17
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.16
Name (Synonyms) Correlation
D008171 Lung Diseases, NIH 0.12

Correlated HPO Terms (3)


Name (Synonyms) Correlation
HP:0006536 Pulmonary obstruction HPO 0.17
HP:0006510 Chronic pulmonary obstruction HPO 0.16
HP:0002088 Abnormal lung morphology HPO 0.12

Clinical Trials

Navigate: Correlations   HPO

There are 2 clinical trials


1 A Prospective, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of ARALAST NP 60 mg/kg and 120 mg/kg for Alpha-1 Proteinase Inhibitor (A1PI) Augmentation Therapy in Subjects With A1PI Deficiency and Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E)

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.

NCT04440488
Conditions
  1. Chronic Obstructive Pulmonary Disease
  2. Alpha1-antitrypsin Deficiency
Interventions
  1. Biological: ARALAST NP
MeSH:Alpha 1-Antitrypsin Deficiency Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Emphysema
HPO:Abnormal lung morphology Chronic pulmonary obstruction Pulmonary obstruction

Primary Outcomes

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

Secondary Outcomes

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
2 A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) Plus Standard Medical Treatment (SMT) Versus Placebo Plus SMT in Hospitalized Subjects With COVID-19

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.

NCT04547140
Conditions
  1. COVID-19
Interventions
  1. Biological: Liquid Alpha1-Proteinase Inhibitor (Human)
  2. Drug: Placebo
  3. Drug: Standard Medical Treatment
MeSH:Alpha 1-Antitrypsin Deficiency

Primary Outcomes

Measure: Percentage of Participants Dying or Requiring ICU Admission

Time: Up to Day 29

Measure: Percentage of Participants Who are Dependent on High Flow Oxygen Devices or Invasive Mechanical Ventilation

Time: Day 29

Secondary Outcomes

Measure: Change from Baseline in National Early Warning Score (NEWS)

Time: Day 1 through Day 29

Measure: Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours

Time: Day 1 through Day 29

Measure: Time to Hospital Discharge

Time: Day 1 through Day 29

Measure: Duration of ICU Stay

Time: Up to Day 29

Measure: Duration of Any Oxygen Use

Time: Day 1 through Day 29

Measure: Duration of Mechanical Ventilation

Time: Up to Day 29

Measure: Mean Change from Baseline in Ordinal Scale

Time: Day 1 through Day 29

Measure: Absolute Value Change from Baseline in Ordinal Scale

Time: Day 1 through Day 29

Measure: Percentage of Participants in Each Severity Category of the 7-point Ordinal Scale

Time: Day 15 and Day 29

Measure: Time to Sustained Normalization of Temperature

Time: Up to Day 29

Measure: Percentage of Participants with Normalization of Fever

Time: Up to Day 29

Measure: Number of Participants who Develop Acute Respiratory Distress Syndrome (ARDS)

Time: Up to Day 29

Measure: Length of Time to Clinical Progression

Time: Up to Day 29

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on December 13, 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  

Interventions

4,818 reports on interventions/drugs

MeSH

706 reports on MeSH terms

HPO

306 reports on HPO terms

All Terms

Alphabetical index of all Terms

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