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- Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Overcoming Racial and Ethnic Biases in the Diagnosis of Patients With Alpha-1 Antitrypsin Deficiency in the United States Using a Machine-learning Model (San Diego Convention Center, Room 28A-B (Upper Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_7578;
Deploying this model in a US healthcare system can help identify patients of different races/ethnicities with rare diseases like AATD and help improve outcomes for such patients. Takeda Pharmaceuticals USA, Inc.
- Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Alpha-1-Antitrypsin Deficiency Discovered Following Nephrectomy (San Diego Convention Center, Area G (Hall A-B2, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_6159;
The pleurisy was attributed to inflammatory pleural fluid following right-sided nephrectomy and improved with a prednisone burst...He was started on AAT augmentation with Aralast with stabilization of symptoms...A case report by Annunziata and colleagues (2021) demonstrated how late diagnosis of AATD in an elderly non-smoker resulted in frequent exacerbations and airway hyperresponsiveness. Therefore, we recommend maintaining high suspicion for AATD in patients with extensive emphysema and no smoking history.
- | Zemaira (human alpha-1 antitrypsin intravenous) / CSL Behring, Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda, Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Journal: Purified Versus Plasma Alpha-1 Antitrypsin Effects on Cellular Activities. (Pubmed Central) - Dec 18, 2023
By adding purified exogenous alpha-1 antitrypsin (AAT) to peripheral blood mononuclear cells in 20% autologous serum and measuring AAT-induced cellular adherence, it was determined that purified AAT differs from plasma AAT. The known association of AAT with lipoproteins and the negative feedback between AAT and low-density lipoprotein (LDL) suggest that purification may separate AAT from a plasma component such as LDL that participates in their normal plasma functions.
- |||| fazirsiran (TAK-999) / Arrowhead, Takeda, Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
New P3 trial: Study to Learn About the Safety of Fazirsiran and if it Can Help People With Alpha-1 Antitrypsin Liver Disease With Mild Liver Scarring (Fibrosis) (clinicaltrials.gov) - Dec 11, 2023
P3, N=50, Not yet recruiting, Sponsor: Takeda
- | Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Reimbursement, Retrospective data, US reimbursement, Journal: Liver disease epidemiology and burden in patients with alterations in plasma protein metabolism: German retrospective insurance claims analysis. (Pubmed Central) - Nov 16, 2023
The known association of AAT with lipoproteins and the negative feedback between AAT and low-density lipoprotein (LDL) suggest that purification may separate AAT from a plasma component such as LDL that participates in their normal plasma functions. Among patients with liver disease, those with APPM experience substantial burden and earlier liver disease progression than patients without APPM.
- | Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Journal: Evaluation of body weight-based dosing, alternative dosing regimens, and treatment interruptions for ?1-proteinase inhibitors and implications on biochemical efficacy in patients with ?1-antitrypsin deficiency. (Pubmed Central) - Nov 6, 2023
Among patients with liver disease, those with APPM experience substantial burden and earlier liver disease progression than patients without APPM. Findings suggest that doses higher than 60mg/kg administered QW might be more clinically beneficial in some patients with AATD, and that body weight should be considered in dose optimization.
- | Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Observational data, Journal: Liver disease progression in patients with alpha-1 antitrypsin deficiency and protease inhibitor ZZ genotype with or without lung disease. (Pubmed Central) - Oct 30, 2023
In patients with AATD and lung disease, there is a delay in the diagnosis of comorbid liver disease. Our findings suggest that liver disease may progress more rapidly in patients without comorbid lung disease.
- || fazirsiran (TAK-999) / Arrowhead, Takeda, Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Enrollment open: An Extension Study to Learn About the Long-Term Safety of Fazirsiran and if Fazirsiran Can Help People With Alpha-1 Antitrypsin Liver Disease (clinicaltrials.gov) - Oct 10, 2023
P3, N=37, Recruiting, Sponsor: Takeda
Our findings suggest that liver disease may progress more rapidly in patients without comorbid lung disease. Not yet recruiting --> Recruiting
- | Enbrel (etanercept) / Pfizer, Amgen, Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Trial completion date: Anti-inflammatory Therapy to Improve Outcomes After TPIAT (clinicaltrials.gov) - Aug 14, 2023
P4, N=44, Active, not recruiting, Sponsor: University of Minnesota
Not yet recruiting --> Recruiting Trial completion date: Jul 2026 --> May 2025
- CHARACTERIZATION, TREATMENT PATTERNS, AND HEALTH CARE RESOURCE UTILIZATION OF INDIVIDUALS WITH ALPHA-1 ANTITRYPSIN DEFICIENCY IN A UNITED STATES MEDICARE ADVANTAGE POPULATION (Convention Center Exhibit Hall - Rapid Area 3A) - Aug 4, 2023 - Abstract #CHEST2023CHEST_4071;
- EVALUATING TESTING RATES FOR ALPHA-1 ANTITRYPSIN DEFICIENCY AMONG INDIVIDUALS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE ENROLLED IN MEDICARE ADVANTAGE IN THE UNITED STATES (Convention Center Exhibit Hall - Rapid Area 3A) - Aug 4, 2023 - Abstract #CHEST2023CHEST_4070;
- |||| fazirsiran (TAK-999) / Arrowhead, Takeda, Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
New P3 trial: An Extension Study to Learn About the Long-Term Safety of Fazirsiran and if Fazirsiran Can Help People With Alpha-1 Antitrypsin Liver Disease (clinicaltrials.gov) - Jun 12, 2023
P3, N=37, Not yet recruiting, Sponsor: Takeda
- Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Takeda: "Alpha-1 antitrypsin deficiency (AATD) - Associated liver disease: More common than you may think" (Stolz 1) - May 31, 2023 - Abstract #EASLILC2023EASL_ILC_2709;
Trial completion date: Jul 2026 --> May 2025 Sponsored by Takeda.Learning Objectives
- | Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Enrollment change, Trial withdrawal, Head-to-Head: A Study of RYMPHYSIA for Alpha1-Proteinase Inhibitor (A1PI) Therapy in Adults With A1PI Deficiency and Chronic Obstructive Pulmonary Disease (COPD)-Emphysema (clinicaltrials.gov) - May 6, 2023
P4, N=0, Withdrawn, Sponsor: Takeda
Sponsored by Takeda.Learning Objectives N=214 --> 0 | Not yet recruiting --> Withdrawn
- fazirsiran (TAK-999) / Arrowhead, Takeda, Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Fazirsiran reduces liver Z-alpha-1 antitrypsin synthesis, decreases globule burden and improves histological measures of liver disease in adults with alpha-1 antitrypsin deficiency: a randomized placebo-controlled phase 2 study (Lehar 1-2) - Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_1513;
P2
These results support further development of fazirsiran in larger phase 3 studies. Funded by Arrowhead.
- Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Liver-related clinical events among adult patients with alpha-1 antitrypsin deficiency-associated liver disease: a longitudinal retrospective study using linked insurance claims data and electronic medical records in the United States (Poster Area) - Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_847;
These rates were higher when patients had both liver and lung disease involvement than liver disease only, possibly related to the higher median age of patients with both diseases. The number of patients with a confirmed PiZZ/PiMZ genotype was very low (AATD-liver disease: n = 11; AATD-liver+lung disease: n = 5), restricting further analysis.
- Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Differences in the rates of liver-related clinical events in paediatric patients with alpha-1 antitrypsin deficiency-associated liver disease in the United States (Poster Area) - Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_829;
The number of patients with a confirmed PiZZ/PiMZ genotype was very low (AATD-liver disease: n = 11; AATD-liver+lung disease: n = 5), restricting further analysis. Liver-related clinical event rates were generally similar between paediatric patients with AATD- associated liver disease aged < 1 year and 1
- Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Understanding the experience of patients with alpha-1 antitrypsin deficiency (AATD)-associated liver disease (Poster Area) - Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_828;
Although experiences varied, several concepts were frequently reported and characterized as moderately/highly bothersome/disturbing, even in patients with earlier fibrosis stages which are presumed to be asymptomatic. Clinical outcome assessments that can capture salient concepts are needed to assess the nuances of each patient
- Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Survey of Diagnostic Journey, Treatment Experience, and Impact on Daily Living of Patients With Alpha-1 Antitrypsin Deficiency (Walter E. Washington Convention Center, Area I, Hall C (Lower Level)) - Mar 25, 2023 - Abstract #ATS2023ATS_7580;
Seven participants reported positive experiences with augmentation therapy for AATD symptom management. Most participants reported having good communication with their HCPs and believed they could set realistic AATD management goals.
- Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Machine-learning Model Identifies Patients With High Probability of Alpha-1 Antitrypsin Deficiency Across the United States (Walter E. Washington Convention Center, Area D, Hall C (Lower Level)) - Mar 25, 2023 - Abstract #ATS2023ATS_4834;
The goal of identifying symptomatic patients in a timely manner is to help diagnose other at-risk, presymptomatic family members, and enable appropriate lifestyle modifications, access to augmentation therapy and/or other care specific to their underlying genetic susceptibility for AATD that can prevent or delay the severity of the disease. Takeda Pharmaceuticals USA, Inc.
- Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Machine-learning Model Identifies Patients With Alpha-1 Antitrypsin Deficiency (AATD): Expert Validation and Comparison of Journeys for Patients With AATD Versus Chronic Obstructive Pulmonary Disease (Walter E. Washington Convention Center, Area E, Hall C (Lower Level)) - Mar 25, 2023 - Abstract #ATS2023ATS_4650;
Takeda Pharmaceuticals USA, Inc. funded the study and writing support.
- Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
HEALTHCARE RESOURCE UTILIZATION AND COSTS AMONG PATIENTS WITH ALPHA-1 ANTITRYPSIN DEFICIENCY (AATD) WITH LIVER AND/OR LUNG DISEASE (South Hall A, Poster Hall - McCormick Place) - Mar 23, 2023 - Abstract #DDW2023DDW_1608;
The overall burden may be underestimated due to under-representation of older pts who are more likely to have AATD and lung/liver manifestations. The number of pts with a confirmed PiZZ/PiMZ genotype was very low restricting further analysis.
- ||| Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Trial initiation date, Head-to-Head: A Study of RYMPHYSIA for Alpha1-Proteinase Inhibitor (A1PI) Therapy in Adults With A1PI Deficiency and Chronic Obstructive Pulmonary Disease (COPD)-Emphysema (clinicaltrials.gov) - Feb 9, 2023
P4, N=214, Not yet recruiting, Sponsor: Takeda
The number of pts with a confirmed PiZZ/PiMZ genotype was very low restricting further analysis. Initiation date: Jan 2023 --> Jan 2024
- Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Alpha-1 Insight: A Mixed Method, Retrospective/Prospective, Descriptive Study of Diagnostic Journey, Experiences, and Insights of Patients with Alpha-1-Antitrypsin Deficiency (Convention Center, Lobby Level, Hall 2) - Feb 4, 2023 - Abstract #AAAAI2023AAAAI_1519;
Patients experienced barriers to diagnosis and treatment but were generally satisfied with AATD-related care, particularly after identifying appropriate HCPs. Findings will inform future survey research on AATD patient journeys.PatientsLikeMe conducted this study in collaboration with Takeda Pharmaceuticals USA, Inc.
- Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
EPIDEMIOLOGY ESTIMATES FOR ALPHA-1 ANTITRYPSIN DEFICIENCY (AATD) AND AATD-ASSOCIATED LIVER DISEASE (AATD-LD) IN PEDIATRIC AND ADULT POPULATIONS BASED ON A SYSTEMATIC LITERATURE REVIEW () - Oct 23, 2022 - Abstract #AASLD2022AASLD_1763;
The prevalence of AATD-LD was higher in patients with Pi*ZZ genotype (up to 30%) than in patients overall. The broad ranges for AATD and AATD-LD prevalence by genotype warrant further research into the epidemiology of this rare genetic disease.
- Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
A MACHINE-LEARNING MODEL USING MEDICAL CLAIMS DATA TO IDENTIFY PATIENTS WITH ALPHA-1-ANTITRYPSIN DEFICIENCY (AATD) AMONG THOSE WITH UNEXPLAINED LIVER DISEASES (ULD) () - Oct 23, 2022 - Abstract #AASLD2022AASLD_1470;
Our patient-detection model showed high accuracy in predicting AATD among patients with diagnoses for liver diseases using data recorded in their medical claims. Fourteen clinical predictive features were identified that distinguished patients with AATD from those with ULD.
- Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
CHARACTERIZING LIVER DISEASE (LD) PROGRESSION IN ALPHA-1 ANTITRYPSIN DEFICIENCY (AATD) WITH VERSUS (VS) WITHOUT LUNG DISEASE (Room 145) - Oct 23, 2022 - Abstract #AASLD2022AASLD_334;
Among pts with F3 at baseline, those with LD alone progressed more than twice as fast to F4cc ≤ 5 y than pts with both LD and lung disease. Further research is needed to investigate on the impact of lung disease on LD progression in AATD-LD-PiZZ.
- || Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Clinical data, Journal: A stacking ensemble machine learning model to predict alpha-1 antitrypsin deficiency-associated liver disease clinical outcomes based on UK Biobank data. (Pubmed Central) - Oct 19, 2022
The proposed stacking ensemble ML model showed clinically meaningful accuracy and appeared superior to any single ML algorithms in the ensemble, e.g., the AUROC for AATD-LD was 68.1%, 75.9%, 91.2%, and 67.7% for all-cause mortality, liver-related death, liver transplant, and all-cause mortality or liver transplant, respectively. This work supports the use of ML to address the unanswered clinical questions with clinically meaningful accuracy using real-world data.
- Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
PREDICTIVE MODELING TO IDENTIFY UNDIAGNOSED PATIENTS WITH ALPHA-1 ANTITRYPSIN DEFICIENCY USING MACHINE LEARNING AND MEDICAL CLAIMS DATA (Convention Center Exhibit Hall: Rapid Area 3D) - Sep 11, 2022 - Abstract #CHEST2022CHEST_3146;
The accuracy of the learned patient detection models was high and robust to noise in claim's record data, enabling scalable detection of patients with undiagnosed AATD. Eleven clinical predictive features that distinguish patients with AATD from those with COPD were identified.
- || Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
PK/PD data, Retrospective data, Journal: Pharmacokinetics and Biochemical Efficacy of an α-Proteinase Inhibitor (Aralast NP) in α-Antitrypsin Deficiency: a Cross-Product Retrospective Comparability Analysis. (Pubmed Central) - Aug 25, 2022
P1, P4
Eleven clinical predictive features that distinguish patients with AATD from those with COPD were identified. These retrospective analyses provide robust evidence that Aralast NP has biochemical efficacy and PK comparable to that of Aralast and Prolastin, supporting the use of any of these A1PI products for the treatment of patients with AATD.
- | Enbrel (etanercept) / Pfizer, Amgen, Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Enrollment closed, Trial completion date, Trial primary completion date: Anti-inflammatory Therapy to Improve Outcomes After TPIAT (clinicaltrials.gov) - Aug 15, 2022
P4, N=44, Active, not recruiting, Sponsor: University of Minnesota
These retrospective analyses provide robust evidence that Aralast NP has biochemical efficacy and PK comparable to that of Aralast and Prolastin, supporting the use of any of these A1PI products for the treatment of patients with AATD. Recruiting --> Active, not recruiting | Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Jul 2022 --> Jul 2023
- |||| Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
New P4 trial, Head-to-Head: A Study of RYMPHYSIA for Alpha1-Proteinase Inhibitor (A1PI) Therapy in Adults With A1PI Deficiency and Chronic Obstructive Pulmonary Disease (COPD)-Emphysema (clinicaltrials.gov) - Jul 20, 2022
P4, N=168, Not yet recruiting, Sponsor: Takeda
- Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
ARALAST® NP (RYMPHYSIA®) [Alpha-1 Proteinase Inhibitor (Human)] Clinical Efficacy Study: Advancing research in patients with AATD (Industry Virtual Channel) - Jun 27, 2022 - Abstract #ERS2022ERS_4595;
Recruiting --> Active, not recruiting | Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Jul 2022 --> Jul 2023 Sponsored by Takeda Pharmaceuticals International GmbH
- || Glassia (alpha1-proteinase inhibitor (Human)) / Kamada, Takeda, Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Clinical, Journal: Comparative biochemical efficacy analysis of an alpha-proteinase inhibitor (Glassia®) in patients with alpha-1 antitrypsin deficiency. (Pubmed Central) - Jun 9, 2022
P2/3
For functional A1PI, the GMR (90% CI) was 98.7 (92.5-105.4) for baseline corrected and 107.8% (102.3-113.5) for uncorrected concentrations. In conclusion, the biochemical efficacy of Glassia using the endpoints of plasma antigenic and functional A1PI trough concentrations at steady state was comparable with Prolastin in patients with AATD.
- Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Progression of liver disease among patients with a new diagnosis of protease inhibitor ZZ alpha-1 antitrypsin deficiency (Poster Area) - May 12, 2022 - Abstract #EASLILC2022EASL_ILC_2204;
In conclusion, the biochemical efficacy of Glassia using the endpoints of plasma antigenic and functional A1PI trough concentrations at steady state was comparable with Prolastin in patients with AATD. Almost 1/3 of F3 pts at baseline progressed to F4 and had LD events in ≤2 y, and >2/3 of F4cc pts had LD events in ≤1 y. These clinically relevant findings need validation in independent cohorts.
- | Enbrel (etanercept) / Pfizer, Amgen, Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Enrollment open, Trial primary completion date: Anti-inflammatory Therapy to Improve Outcomes After TPIAT (clinicaltrials.gov) - Mar 2, 2022
P4, N=45, Recruiting, Sponsor: University of Minnesota
Almost 1/3 of F3 pts at baseline progressed to F4 and had LD events in ≤2 y, and >2/3 of F4cc pts had LD events in ≤1 y. These clinically relevant findings need validation in independent cohorts. Active, not recruiting --> Recruiting | Trial primary completion date: Dec 2021 --> Jul 2022
- Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Elastase Complex Formation Immunosorbent Assay (ECFISA) for the Sensitive Measurement of Alpha-1 Antitrypsin Elastase Inhibitory Activity (Room 9-10 (South Building, Exhibition Level), Moscone Center) - Feb 19, 2022 - Abstract #ATS2022ATS_2326;
Active, not recruiting --> Recruiting | Trial primary completion date: Dec 2021 --> Jul 2022 ECFISA is an accurate, precise, selective, and sensitive method for AAT activity measurement at low levels previously inaccessible for direct measurement.
- || Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Clinical, Journal: Alpha-1 Antitrypsin Deficiency-Associated Clinical Manifestations and Healthcare Resource Use in the United States. (Pubmed Central) - Jan 18, 2022
Higher percentages of patients with severe AATD were prescribed augmentation therapy, antibiotics, or corticosteroids. These findings suggest that patients with severe AATD have higher incidence of AATD-associated PEs, as well as higher HRU and healthcare costs.
- | Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Journal: Therapeutic benefits of recombinant alpha1-antitrypsin IgG1 Fc-fusion protein in experimental emphysema. (Pubmed Central) - Jan 4, 2022
These effects were associated with immunomodulatory effects on DC activity. AAT-Fc may provide a therapeutic option to individuals with AATD- and CS-induced emphysema.
- | Enbrel (etanercept) / Pfizer, Amgen, Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Trial completion date, Trial primary completion date: Anti-inflammatory Therapy to Improve Outcomes After TPIAT (clinicaltrials.gov) - Sep 29, 2021
P4, N=45, Active, not recruiting, Sponsor: University of Minnesota
AAT-Fc may provide a therapeutic option to individuals with AATD- and CS-induced emphysema. Trial completion date: Jan 2024 --> Jul 2025 | Trial primary completion date: Jan 2021 --> Dec 2021
- Aralast NP (alpha 1-antitrypsin) / Omni Bio, Takeda
[VIRTUAL] Method Validation for the Measurement of Alpha-1 Antitrypsin Protein in Clinical Samples () - Mar 14, 2021 - Abstract #ATS2021ATS_4301;
Both assays for the measurement of AAT protein met the acceptance criteria defined by the EMA guideline for bioanalytical assay validation. This data qualified the assays to be used for the measurement of clinical samples.
- Aralast NP (alpha 1-antitrypsin) / Omni Bio, Takeda
[VIRTUAL] Method Validation for the Measurement of Alpha-1 Antitrypsin Activity in Clinical Samples () - Mar 14, 2021 - Abstract #ATS2021ATS_415;
The assay for the measurement of AAT activity met the acceptance criteria defined by the EMA guideline for bioanalytical assay validation. This qualified the sensitive AAT activity assay ECFISA to be used for the measurement of clinical samples.
- |||| Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
New P3 trial: Aralast NP With Antiviral Treatment and Standard of Care Versus Antiviral Treatment With Standard of Care in Hospitalized Patients With Pneumonia and COVID-19 Infection (clinicaltrials.gov) - Dec 19, 2020
P3, N=20, Not yet recruiting, Sponsor: Blessing Corporate Services, Inc
- | Enbrel (etanercept) / Pfizer, Amgen, Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Enrollment closed: Anti-inflammatory Therapy to Improve Outcomes After TPIAT (clinicaltrials.gov) - Oct 28, 2020
P4, N=45, Active, not recruiting, Sponsor: University of Minnesota
This qualified the sensitive AAT activity assay ECFISA to be used for the measurement of clinical samples. Recruiting --> Active, not recruiting
- | Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Enrollment change, Trial withdrawal: ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study (clinicaltrials.gov) - Sep 13, 2020
P4, N=0, Withdrawn, Sponsor: Shire
Recruiting --> Active, not recruiting N=168 --> 0 | Not yet recruiting --> Withdrawn
- Aralast NP (alpha 1-antitrypsin) / Omni Bio, Takeda
[VIRTUAL] Pharmacotherapy Treatment Patterns and Antibiotic and Corticosteroid Use in Patients with Severe and Non-Severe Alpha-1 Antitrypsin Deficiency in the United States (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_5190;
HRU was clinically and statistically greater in patients with severe versus non-severe AATD in terms of the use of augmentation therapy, antibiotics, and corticosteroids. Augmentation therapy was most often administered as a single regimen, with the frequency of switching treatments being low.
- Aralast NP (alpha 1-antitrypsin) / Omni Bio, Takeda
[VIRTUAL] Long-Term Stability of Alpha1-Proteinase Inhibitor and Urea in Biological Sample Matrices (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_5104;
Interestingly, the analyte concentration did not show any significant influence on the results in both plasma and BAL-mimicking samples. Conclusions The data confirmed the long-term stability up to 18 months of the three common analytes in the biological matrix of citrated plasma and in BAL-mimicking sample.
- |||| Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
New P4 trial: ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study (clinicaltrials.gov) - Jun 18, 2020
P4, N=168, Not yet recruiting, Sponsor: Shire
- Aralast NP (alpha 1-antitrypsin) / Omni Bio, Takeda
Analysis of Healthcare Resource Use and Time to Resource Use in US Patients Experiencing Pulmonary-Related Clinical Manifestations Associated With Severe Versus Non-severe Alpha-1 Antitrypsin Deficiency () - May 6, 2020 - Abstract #AMCP2020AMCP_104;
Patients with severe AATD had significantly greater HRU and shorter time to HRU, suggesting disease burden was greater in severe AATD patients. Sponsorship: Shire US Inc., a Takeda company, Lexington, MA
- |||| Aralast NP (alpha 1-antitrypsin) / Omni Bio, Takeda
Clinical: I take Aralast for alpha1 disease and have wondered if it would help covid patients. Also what makes young blood fight this better? Metabolism, growth hormone, some higher use levels of a basic vitamin, marrow, cellular life cycles. (Twitter) - Mar 18, 2020