Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific 
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5 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
BATMAN, NCT05582798: Bronchiectasis Alpha-1 Augmentation Trial- Modulating Airway Neutrophil Function

Completed
4
20
Europe
Alpha 1-Proteinase Inhibitor 180mg/kg, Prolastin-C Liquid, Alpha 1-Proteinase Inhibitor 120mg/kg, Sodium chloride
University of Dundee
Bronchiectasis Adult
08/24
08/24
SPARTA, NCT01983241 / 2013-001870-38: Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)

Active, not recruiting
3
345
Europe, Canada, US, RoW
Alpha-1 MP, Prolastin-C, 0.9% Sodium Chloride for Injection, USP, Saline
Grifols Therapeutics LLC
Pulmonary Emphysema in Alpha-1 PI Deficiency
08/26
01/27
SPARTA-OLE, NCT02796937 / 2015-004110-23: Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency

Enrolling by invitation
3
290
Europe, Canada, US, RoW
Alpha-1 MP, Prolastin-C
Grifols Therapeutics LLC, Grifols Therapeutics LLC
Pulmonary Emphysema in Alpha-1 Antitrypsin Deficiency
09/28
02/29
NCT02947087: Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis

Completed
1/2
48
US
Prolastin-C, AAT, Placebo, Saline
Medical University of South Carolina, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Chronic Pancreatitis
11/21
11/22
NCT04722887: A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Participants with Alpha1-Antitrypsin Deficiency

Active, not recruiting
1/2
16
US
Alpha-1 15%, Liquid Alpha1-Proteinase Inhibitor (Human), Prolastin®-C Liquid
Grifols Therapeutics LLC
Alpha1-Antitrypsin Deficiency
07/25
07/25
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
BATMAN, NCT05582798: Bronchiectasis Alpha-1 Augmentation Trial- Modulating Airway Neutrophil Function

Completed
4
20
Europe
Alpha 1-Proteinase Inhibitor 180mg/kg, Prolastin-C Liquid, Alpha 1-Proteinase Inhibitor 120mg/kg, Sodium chloride
University of Dundee
Bronchiectasis Adult
08/24
08/24
SPARTA, NCT01983241 / 2013-001870-38: Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)

Active, not recruiting
3
345
Europe, Canada, US, RoW
Alpha-1 MP, Prolastin-C, 0.9% Sodium Chloride for Injection, USP, Saline
Grifols Therapeutics LLC
Pulmonary Emphysema in Alpha-1 PI Deficiency
08/26
01/27
SPARTA-OLE, NCT02796937 / 2015-004110-23: Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency

Enrolling by invitation
3
290
Europe, Canada, US, RoW
Alpha-1 MP, Prolastin-C
Grifols Therapeutics LLC, Grifols Therapeutics LLC
Pulmonary Emphysema in Alpha-1 Antitrypsin Deficiency
09/28
02/29
NCT02947087: Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis

Completed
1/2
48
US
Prolastin-C, AAT, Placebo, Saline
Medical University of South Carolina, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Chronic Pancreatitis
11/21
11/22
NCT04722887: A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Participants with Alpha1-Antitrypsin Deficiency

Active, not recruiting
1/2
16
US
Alpha-1 15%, Liquid Alpha1-Proteinase Inhibitor (Human), Prolastin®-C Liquid
Grifols Therapeutics LLC
Alpha1-Antitrypsin Deficiency
07/25
07/25

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