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- Prolastin (alpha-1 antitrypsin inhibitor) / Grifols
Patterns in Patient and Provider Characteristics Over Time Among Patients Initiating Alpha-1 Proteinase Inhibitors (San Diego Convention Center, Area B (Hall A-B2, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_1005;
The study provides insights into the real-world clinical practice of A1PI administration in the United States. Additional research is needed to better identify existing barriers that delay or hinder care delivery and management.
- | 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.
- | Zemaira (human alpha-1 antitrypsin intravenous) / CSL Behring
Journal: Indirect effect of alpha-1-antitrypsin on endotoxin-induced IL-1β secretion from human PBMCs. (Pubmed Central) - Oct 18, 2022
Our data show that a free Cys232 in AAT is required for controlling LPS-induced IL-1β release from human PBMCs. Further studies characterizing AAT preparations used to treat patients with inherited AAT deficiency remains of clinical importance.
- || 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
Further studies characterizing AAT preparations used to treat patients with inherited AAT deficiency remains of clinical importance. 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.
- | Prolastin (alpha-1 antitrypsin inhibitor) / Grifols
Journal: Impact of COVID-19 pandemic on information management and adherence to replacement therapy with AAT of patients with alpha-1 antitrypsin deficiency (AATM) (Pubmed Central) - Jul 28, 2022
This may have resulted in an COVID-19 infection rate lower than the general population. Although respondents were concerned about exposure to COVID-19 in their doctor's office or clinic, very few discontinued therapy even temporarily.
- || 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.
- || Prolastin (alpha-1 antitrypsin inhibitor) / Grifols
Clinical, Journal: A randomized, double-blind, placebo-controlled trial of intravenous alpha-1 antitrypsin for acute respiratory distress syndrome secondary to COVID-19. (Pubmed Central) - Mar 17, 2022
P2
Patients (n=36) were randomized to receive weekly placebo, weekly AAT (Prolastin, Grifols, S.A.; 120mg/kg), or AAT once followed by weekly placebo...In patients with COVID-19 and moderate-to-severe ARDS, treatment with IV AAT was safe, feasible and biochemically efficacious. The data support progression to a phase 3 trial, and prompt further investigation of AAT as an anti-inflammatory therapeutic.
- Prolastin (alpha-1 antitrypsin inhibitor) / Grifols
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Alpha-1 Antitrypsin for ARDS Secondary to Severe COVID-19 (Room 3005/3007 (West Building, Level 3), Moscone Center) - Feb 19, 2022 - Abstract #ATS2022ATS_5952;
In patients with COVID-19 and moderate-to-severe ARDS, treatment with IV AAT was safe, feasible and biochemically efficacious. The data support progression to a large phase 3 trial focusing on clinical endpoints, and prompt further investigation of AAT as an anti-inflammatory therapeutic.
- Prolastin (alpha-1 antitrypsin inhibitor) / Grifols
Severe Hyperinflation of Ipsilateral Lobes After Bronchoscopic Lung Volume Reduction Surgery (Area J, Hall F (North Building, Exhibition Level), Moscone Center) - Feb 19, 2022 - Abstract #ATS2022ATS_4427;
She was already on maximal medical therapy for emphysema and prolastin infusion...It is also not known if these patients pose a higher risk for pneumothorax at baseline and should additional BLVRS be offered to these patients. This patient has worsening shortness of breath with decreased exercise tolerance and has been referred for lung transplant.
- Prolastin (alpha-1 antitrypsin inhibitor) / Grifols
Increased Circulating Alpha-1 Antitrypsin Confers a Short- and Long-Term Survival Benefit in Acute Respiratory Distress Syndrome (Room 3009/3011 (West Building, Level 3), Moscone Center) - Feb 19, 2022 - Abstract #ATS2022ATS_4070;
In conclusion, increased AAT in plasma is associated with better outcomes in ARDS. IV Prolastin® attenuated preclinical pneumonia induced ARDS and offers further evidence for supplementation of AAT in ARDS.
- || Prolastin (alpha-1 antitrypsin inhibitor) / Grifols
Clinical, Journal: Human plasma-derived alpha -proteinase inhibitor in patients with new-onset type 1 diabetes mellitus: a randomized, placebo-controlled proof-of-concept study. (Pubmed Central) - Jan 11, 2022
P2
cell destruction and reduced insulin production, it has been proposed for T1DM disease prevention. To evaluate safety, tolerability and efficacy of IV Alpha -PI[human] in preserving C-peptide production in newly diagnosed T1DM patients.
- | Prolastin (alpha-1 antitrypsin inhibitor) / Grifols
Preclinical, Journal: α1-Antitrypsin A treatment attenuates neutrophil elastase accumulation and enhances insulin sensitivity in adipose tissue of mice fed a high-fat diet. (Pubmed Central) - Nov 10, 2021
Male C57Bl/6j mice fed a chow or a high-fat diet (HFD) were randomized to receive intraperitoneal injections three times weekly of either Prolastin (human A1AT; 2 mg) or vehicle (PBS) for 10 wk...Furthermore, PDGF mediated p-Akt activation and glucose uptake (which is independent of IRS-1) was not affected by recombinant NE treatment. Collectively, our findings suggest that NE infiltration of WAT during metabolic overload contributes to insulin-resistance by impairing insulin-induced IRS-1 signaling.
- | Prolastin (alpha-1 antitrypsin inhibitor) / Grifols
Journal: Commercial α1-antitrypsin preparations markedly differ in their potential to inhibit the ATP-induced release of monocytic interleukin-1β. (Pubmed Central) - Oct 1, 2021
Our data suggest that the anti-inflammatory potential and the anti-protease function of AAT can be fully uncoupled. In the light of the increasing clinical interest in anti-inflammatory functions of AAT, commercial AAT preparations should be carefully reinvestigated and optimized to preserve the dual anti-protease and anti-inflammatory activity of native AAT.
- Zemaira (human alpha-1 antitrypsin intravenous) / CSL Behring
Phase classification: Therapy to Elevate CD4 Counts in HIV-1 Disease (clinicaltrials.gov) - Sep 28, 2021
P2/3, N=4, Completed, Sponsor: Institute for Human Genetics and Biochemistry
In the light of the increasing clinical interest in anti-inflammatory functions of AAT, commercial AAT preparations should be carefully reinvestigated and optimized to preserve the dual anti-protease and anti-inflammatory activity of native AAT. Phase classification: P=N/A --> P2/3
- ||| Prolastin (alpha-1 antitrypsin inhibitor) / Grifols
Trial completion: Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19 (clinicaltrials.gov) - Jul 8, 2021
P2, N=100, Completed, Sponsor: Instituto Grifols, S.A.
Phase classification: P=N/A --> P2/3 Active, not recruiting --> Completed
- || Prolastin (alpha-1 antitrypsin inhibitor) / Grifols
Enrollment closed: Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19 (clinicaltrials.gov) - May 3, 2021
P2, N=100, Active, not recruiting, Sponsor: Instituto Grifols, S.A.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || Prolastin (alpha-1 antitrypsin inhibitor) / Grifols
Clinical, Clinical protocol, Journal: A randomised, double-blind, placebo-controlled, pilot trial of intravenous plasma purified alpha-1 antitrypsin for SARS-CoV-2-induced Acute Respiratory Distress Syndrome: a structured summary of a study protocol for a randomised, controlled trial. (Pubmed Central) - Apr 27, 2021
P2
The primary objective is to demonstrate that, in patients with PCR-confirmed SARS-CoV-2 resulting in Acute Respiratory Distress Syndrome (ARDS), administration of 120mg/kg of body weight of intravenous Prolastin®(plasma-purified alpha-1 antitrypsin) reduces circulating plasma levels of interleukin-6 (IL-6)...In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).
- Prolastin (alpha-1 antitrypsin inhibitor) / Grifols
[VIRTUAL] Therapeutic Effects of Alpha 1 Antitrypsin Supplementation in Preclinical Acute Respiratory Distress Syndrome () - Mar 14, 2021 - Abstract #ATS2021ATS_1994;
In conclusion, increased AAT in plasma is associated with better outcomes in ARDS and patients with concomitant AATD may be at a disadvantage. IV Prolastin® attenuated preclinical pneumonia induced ARDS and offers further evidence for supplementation of AAT in ARDS.
- || Prolastin (alpha-1 antitrypsin inhibitor) / Grifols
Trial completion date, Trial primary completion date: Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19 (clinicaltrials.gov) - Oct 9, 2020
P2, N=100, Recruiting, Sponsor: Instituto Grifols, S.A.
IV Prolastin® attenuated preclinical pneumonia induced ARDS and offers further evidence for supplementation of AAT in ARDS. Trial completion date: Nov 2020 --> Apr 2021 | Trial primary completion date: Nov 2020 --> Mar 2021
- |||| Prolastin (alpha-1 antitrypsin inhibitor) / Grifols
New P2 trial: Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19 (clinicaltrials.gov) - Aug 7, 2020
P2, N=100, Recruiting, Sponsor: Instituto Grifols, S.A.
- | Prolastin (alpha-1 antitrypsin inhibitor) / Grifols
New P2 trial: A randomized double-blind placebo-controlled trial of intravenous plasma-purified alpha-1 antitrypsin for severe COVID-19 illness. (EUDRACT) - Apr 25, 2020
P2, N=36, Ongoing, Sponsor: Royal College of Surgeons Ireland
- ||| Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion, Gamunex-C (human immune globulin 10%- caprylate/ chromatography purified) / Kedrion, Grifols, Prolastin (alpha-1 antitrypsin inhibitor) / Grifols
Enrollment change: Use of Immune Globulin Intravenous (Human) To Treat Age-Related Macular Degeneration (clinicaltrials.gov) - Mar 21, 2016
P2, N=96, Completed, Sponsor: Grifols Therapeutics Inc.
Trial completion date: Nov 2020 --> Apr 2021 | Trial primary completion date: Nov 2020 --> Mar 2021 N=57 --> 96
- Prolastin (alpha-1 antitrypsin inhibitor) / Grifols
New P2 trial: Alpha1 Antitrypsin Aerosol Therapy in Cystic Fibrosis (clinicaltrials.gov) - Dec 10, 2013
P2, N=30, Terminated, Sponsor: Université de Sherbrooke