Clinical trials: Alpha-1 Proteinase Inhibitor
Alpha-1 Antitrypsin Deficiency
Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency
In the context of the increasing evidence of the pathogenetic role of microbiome in COPD, our aim is to determine the total and specific bacterial and viral load in sputa from patients with COPD due to AATD and to correlate these…
- Trial name
- AATD (NCT02547532)
- Testing
- collection of sputum
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fondazione Salvatore Maugeri
Healthy, Pulmonary Fibrosis
Identification of Genes Associated With Lung Disease in Patients With Rheumatoid Arthritis
Pulmonary fibrosis (PF) is a condition in which the lungs of a patient become scarred and fibrous. It has been known to occur in as many as 40% of patients diagnosed with rheumatoid arthritis (RA).
- Conditions
- Healthy, Pulmonary Fibrosis, Rheumatoid Arthritis
- Trial name
- NCT00001885
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Chronic Obstructive Pulmonary Disease, Alpha-1 Antitrypsin Deficiency
Environment Effect on Six-Minute Walk Test Performance
The purpose of this research study is to determine the effect of the environment on six-minute walk test performance in individuals with chronic obstructive pulmonary disease due to alpha-1 antitrypsin deficiency.
- Trial name
- 6MWTAATD (NCT02502201)
- Testing
- six-minute walk study indoors, six-minute walk study outdoors
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- University of Florida
Diabetes, Type 1 Diabetes
The Effects of Alpha-1 Antitrypsin (AAT) on the Progression of Type 1 Diabetes
The purpose of this study is to determine if the drug Alpha-1 Antitrypsin (AAT, Aralast NP) will preserve beta-cell function and help slow the progression of type 1 diabetes.
- Trial name
- NCT01319331
- Testing
- Alpha 1-Antitrypsin (AAT, Aralast NP)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Colorado, Denver
Alpha 1-Antitrypsin Deficiency
Experimental Gene Transfer Procedure to Treat Alpha 1-Antitrypsin Deficiency
Individuals with a deficiency of the Alpha 1-antitrypsin (AAT) protein are at risk for developing emphysema and liver damage. Researchers have developed a way to introduce normal AAT genes into muscle cells so that the AAT…
- Trial name
- NCT00377416
- Testing
- rAAV2-CB-hAAT Gene Vector
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- University of Massachusetts, Worcester
Graft-Versus-Host Disease (GVHD) Acute on Chronic
Alpha 1 Anti-Trypsin (AAT) in Treating Patients With Acute Graft-Versus-Host Disease GVHD)
This phase I/II trial evaluates the efficacy and adverse effects of alpha 1 anti-trypsin (AAT) for the treatment of acute graft-versus-host disease (GVHD) after hematopoietic stem cell transplantation.
- Trial name
- NCT01523821
- Testing
- Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Fred Hutchinson Cancer Center
Irritable Bowel Syndrome (IBS)
IBS-Oriented CDED Versus Low FODMAP Diet for Irritable Bowel Syndrome
Background: Irritable Bowel Syndrome (IBS) affects approximately 4.1% of the global population and imposes a significant personal and healthcare burden.
- Trial name
- IBS-CDED (NCT07707635)
- Testing
- Modified Crohn's Disease Exclusion Diet (CDED), Low FODMAP Diet
- Volunteers
- 150 people
- Sponsor
- Ariel University
Alpha 1-Antitrypsin Deficiency
A Study to Evaluate the Safety and Efficacy of BEAM-302 in Adult Patients With Alpha-1 Antitrypsin Deficiency (AATD)
This is a Phase 1/2, multicenter, open-label study conducted in 3 parts (Part A, Part B, and Part C) to evaluate the safety, tolerability, PK/PD, and efficacy of BEAM-302 in adult patients with AATD-associated lung disease and/or…
- Trial name
- NCT06389877
- Testing
- BEAM-302
- Where
- 12 sites in United States, Australia and 4 more
- Volunteers
- 192 people
- Sponsor
- Beam Therapeutics Inc.
Alpha 1-Antitrypsin Deficiency
A Study of Belcesiran in Patients With AATLD
This is a multiple dose, randomized, placebo-controlled, double-blind study of belcesiran to evaluate the safety, tolerability, PK, and PD in adult patients with PiZZ AATD-associated liver disease (AATLD).
- Trial name
- ESTRELLA (NCT04764448)
- Testing
- Belcesiran
- Where
- 23 sites in United States, Australia and 12 more
- Volunteers
- 16 people
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Alpha1-Antitrypsin Deficiency
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)
The liver produces a protein called alpha-1 antitrypsin (AAT). AAT is normally released into the bloodstream. In some people, the liver makes an abnormal version of the AAT protein, called Z-AAT.
- Trial name
- NCT06165341
- Testing
- Fazirsiran Injection
- Where
- 41 sites in United States, Austria and 11 more
- Volunteers
- 50 people
- Sponsor
- Takeda
Pulmonary Emphysema in Alpha-1 Antitrypsin Deficiency
Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency
This is a 2-year open-label, multicenter extension of the double-blind, placebo-controlled GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data for intravenously administered Alpha1-MP 60…
- Trial name
- SPARTA-OLE (NCT02796937)
- Testing
- Alpha-1 MP
- Where
- 28 sites in United States, Australia and 10 more
- Volunteers
- 290 people
- Sponsor
- Grifols Therapeutics LLC
Graft Versus Host Disease
A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD
The purpose of the study is to evaluate the safety and efficacy of GLASSIA as an add-on biopharmacotherapy to standard-of-care steroid treatment as the first-line treatment in participants with acute GvHD with lower GI…
- Trial name
- NCT02956122
- Testing
- GLASSIA, methylprednisolone or equivalent steroid, Albumin
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Baxalta now part of Shire
Neoplasms, Antioxidants
Oxidoreductive Balance and Lysosomal Activity in Cancer Patients.
The research aims to determine the parameters of oxidative stress and inflammatory processes and compare these parameters with the image obtained using positron emission tomography (PET) with 2-deoxy-2-[fluorine-18]fluoro…
- Conditions
- Neoplasms, Antioxidants, Oxidative Stress, Lipid Peroxidation
- Trial name
- NCT03470857
- Testing
- Patients
- Where
- 3 sites in Poland
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Nicolaus Copernicus University
Chronic Obstructive Pulmonary Disease, Alpha1-antitrypsin Deficiency
Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency
The purpose of this study is to conduct a pilot study to evaluate the safety and efficacy of weekly administration of Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy in subjects with A1PI deficiency and emphysema/ chronic…
- Trial name
- NCT02722304
- Testing
- ARALAST NP 60 mg/kg, ARALAST NP 120 mg/kg, GLASSIA 60 mg/kg
- Where
- 17 sites in United States, Australia and 1 more
- Volunteers
- 7 people
- Sponsor
- Baxalta now part of Shire
Alpha-1 Antitrypsin Deficiency, AATD
Phase 1 Study to Assess the Safety, PK and PD of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency
This is an open-label, 2-part, dose-escalating, Phase 1 study of INBRX-101 (rhAAT-Fc). Part 1 will consist of single ascending dose (SAD) administration of INBRX-101 and Part 2 will consist of multiple ascending dose (MAD)…
- Trial name
- rhAAT-Fc (NCT03815396)
- Testing
- INBRX-101/rhAAT-Fc
- Where
- 10 sites in United States, New Zealand and 1 more
- Volunteers
- 31 people
- Sponsor
- Inhibrx Biosciences, Inc
Alpha-1 Antitrypsin Deficiency (AATD)
Effect Of Pulmonary Rehabilitation in Patients With Alpha-1 Antitrypsin Deficiency
This single-center, longitudinal, observational, prospective study aims to assess the applicability, adherence, and clinical impact of the Active Cycle of Breathing Technique (ACBT) with augmented reality support in patients with…
- Trial name
- RRALFA1 (NCT07242079)
- Testing
- Pulmonary Rehabilitation
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- University of Parma
Alpha-1 Antitrypsin Deficiency, Alpha-1 Antitrypsin Deficiency-associated Lung Disease
A Study of the Safety and Efficacy of Prime Editing (PM647a) in Participants With Alpha-1 Antitrypsin Deficiency
The purpose of this study is to evaluate the safety, tolerability, biological activity, and initial efficacy of PM647a, an investigational Prime Editing therapy, in adults and adolescents with Alpha-1 Antitrypsin Deficiency…
- Conditions
- Alpha-1 Antitrypsin Deficiency, Alpha-1 Antitrypsin Deficiency-associated Lung Disease, Alpha-1 Antitrypsin Deficiency (AATD), AATD
- Trial name
- PM647a (NCT07887347)
- Testing
- PM647a
- Volunteers
- 54 people
- Sponsor
- Prime Medicine, Inc.
Alpha1-antitrypsin Deficiency
Safety Study of an Aerosolized, Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin Deficiency
The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the short-term safety of inhaled recombinant alpha 1-antitrypsin (rAAT) in subjects with alpha 1-antitrypsin deficiency.
- Trial name
- NCT00161707
- Testing
- Aerosolized, Recombinant Alpha 1-Antitrypsin
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Baxalta now part of Shire
Alpha 1-Antitrypsin Deficiency
Study of BMN 349 Single Dose in PiZZ and PiMZ/MASH Adult Participants
The goal of this clinical trial is to assess the safety and tolerability of a single oral dose of BMN 349 in participants with PiZZ or PiMZ/MASH.
- Trial name
- NCT06738017
- Testing
- BMN 349
- Where
- 7 sites in United States, United Kingdom
- Volunteers
- 6 people
- Sponsor
- BioMarin Pharmaceutical
Graft-versus-host-disease, GVHD
A Proof of Concept Pilot Trial of Alpha-1-Antitrypsin for Pre-Emption Of Steroid-Refractory Acute GVHD
Bone marrow transplant (BMT) patients can develop graft-versus-host disease (GVHD), a serious and potentially fatal complication.
- Trial name
- NCT03459040
- Testing
- Alpha 1-Antitrypsin
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- John Levine