Prolastin-C (human alpha1-proteinase inhibitor IV)
/ Grifols, OrphanPacific
- LARVOL DELTA
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February 18, 2026
GC2501: A study to compare the safety and how the body processes two different doses of an under-the-skin Alpha1-Proteinase inhibitor treatment in people with Alpha1-Antitrypsin Deficiency
(clinicaltrialsregister.eu)
- P2/3 | N=38 | Not yet recruiting | Sponsor: Grifols Therapeutics LLC
Head-to-Head β’ New P2/3 trial β’ Alpha-1 Antitrypsin Deficiency β’ Genetic Disorders β’ Pulmonary Disease β’ Respiratory Diseases
December 16, 2025
Co-occurrence of Alpha-1 Antitrypsin Deficiency (AATD) and Common Variable Immunodeficiency (CVID): A Case Report.
(PubMed, Cureus)
- "We report a 47-year-old man with a history of smoking and chronic obstructive pulmonary disease (COPD), diagnosed with the PI*MZ genotype of AATD and treated with human alpha1-proteinase inhibitor (PROLASTIN-C®, Grifols Therapeutics, Clayton, NC, USA)...Combined treatment with alpha-1 antitrypsin (AAT) replacement and intravenous immunoglobulin (IVIG) was initiated, emphasizing the importance of comprehensive genetic and immunologic evaluation and tailored therapy in complex respiratory cases. Further studies are needed to clarify the relationship between AATD and CVID and optimize management strategies."
Journal β’ Alpha-1 Antitrypsin Deficiency β’ Bronchiectasis β’ Chronic Obstructive Pulmonary Disease β’ Genetic Disorders β’ Immunology β’ Infectious Disease β’ Pneumonia β’ Primary Immunodeficiency β’ Pulmonary Disease β’ Respiratory Diseases
December 13, 2025
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
(clinicaltrials.gov)
- P1/2 | N=17 | Completed | Sponsor: Grifols Therapeutics LLC | Active, not recruiting β Completed
Trial completion β’ Alpha-1 Antitrypsin Deficiency β’ Pulmonary Disease β’ Respiratory Diseases
February 24, 2025
Evaluating the Economic Burden: Lifetime Direct and Indirect Costs of Managing Alpha-1 Antitrypsin Deficiency for Patients With the PiZZ Genotype Receiving Augmentation Therapy in the United States
(ATS 2025)
- "Utilization and costs were calculated for hospitalizations, outpatient visits, augmentation therapy (Prolastin-C 1000 mg / 20 ml vials; highest U.S. market share), other medications, oxygen, lab tests, and scans... AATD (PiZZ) imposes a significant economic burden, including both direct and indirect costs."
Clinical β’ HEOR β’ Alpha-1 Antitrypsin Deficiency β’ Bronchiectasis β’ Chronic Obstructive Pulmonary Disease β’ Genetic Disorders β’ Hepatology β’ Immunology β’ Pulmonary Disease β’ Respiratory Diseases
February 12, 2025
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
(clinicaltrials.gov)
- P1/2 | N=16 | Active, not recruiting | Sponsor: Grifols Therapeutics LLC | Trial completion date: Mar 2025 β Jul 2025 | Trial primary completion date: Mar 2025 β Jul 2025
Trial completion date β’ Trial primary completion date β’ Alpha-1 Antitrypsin Deficiency β’ Hepatology β’ Pulmonary Disease β’ Respiratory Diseases
February 04, 2025
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
(clinicaltrials.gov)
- P1/2 | N=16 | Active, not recruiting | Sponsor: Grifols Therapeutics LLC | Recruiting β Active, not recruiting
Enrollment closed β’ Alpha-1 Antitrypsin Deficiency β’ Hepatology β’ Pulmonary Disease β’ Respiratory Diseases
September 03, 2024
BATMAN: Bronchiectasis Alpha-1 Augmentation Trial- Modulating Airway Neutrophil Function
(clinicaltrials.gov)
- P4 | N=20 | Completed | Sponsor: University of Dundee | Recruiting β Completed
Trial completion β’ Bronchiectasis β’ Pulmonary Disease β’ Respiratory Diseases β’ ELANE
March 07, 2024
SPARTA: Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)
(clinicaltrials.gov)
- P3 | N=345 | Active, not recruiting | Sponsor: Grifols Therapeutics LLC | Trial completion date: Aug 2026 β Jan 2027
Trial completion date β’ Alpha-1 Antitrypsin Deficiency β’ Chronic Obstructive Pulmonary Disease β’ Genetic Disorders β’ Hepatology β’ Pulmonary Disease β’ Pulmonary Emphysema β’ Respiratory Diseases
January 25, 2024
SPARTA-OLE: Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency
(clinicaltrials.gov)
- P3 | N=290 | Enrolling by invitation | Sponsor: Grifols Therapeutics LLC | Trial completion date: Jul 2028 β Feb 2029
Trial completion date β’ Alpha-1 Antitrypsin Deficiency β’ Chronic Obstructive Pulmonary Disease β’ Genetic Disorders β’ Hepatology β’ Pulmonary Disease β’ Pulmonary Emphysema β’ Respiratory Diseases
December 11, 2023
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
(clinicaltrials.gov)
- P1/2 | N=16 | Recruiting | Sponsor: Grifols Therapeutics LLC | Trial completion date: Nov 2024 β Mar 2025 | Trial primary completion date: Nov 2024 β Mar 2025
Trial completion date β’ Trial primary completion date β’ Alpha-1 Antitrypsin Deficiency β’ Hepatology β’ Pulmonary Disease β’ Respiratory Diseases
October 03, 2023
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
(clinicaltrials.gov)
- P1/2 | N=16 | Recruiting | Sponsor: Grifols Therapeutics LLC | Trial completion date: Mar 2024 β Nov 2024 | Trial primary completion date: Mar 2024 β Nov 2024
Trial completion date β’ Trial primary completion date β’ Alpha-1 Antitrypsin Deficiency β’ Hepatology β’ Pulmonary Disease β’ Respiratory Diseases
July 28, 2023
SPARTA-OLE: Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency
(clinicaltrials.gov)
- P3 | N=250 | Enrolling by invitation | Sponsor: Grifols Therapeutics LLC | Trial completion date: Apr 2028 β Jul 2028 | Trial primary completion date: Apr 2028 β Jul 2028
Trial completion date β’ Trial primary completion date β’ Alpha-1 Antitrypsin Deficiency β’ Chronic Obstructive Pulmonary Disease β’ Genetic Disorders β’ Hepatology β’ Pulmonary Disease β’ Pulmonary Emphysema β’ Respiratory Diseases
June 23, 2023
SPARTA: Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)
(clinicaltrials.gov)
- P3 | N=339 | Active, not recruiting | Sponsor: Grifols Therapeutics LLC | Recruiting β Active, not recruiting
Enrollment closed β’ Alpha-1 Antitrypsin Deficiency β’ Chronic Obstructive Pulmonary Disease β’ Genetic Disorders β’ Hepatology β’ Pulmonary Disease β’ Pulmonary Emphysema β’ Respiratory Diseases
May 09, 2023
Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis
(clinicaltrials.gov)
- P1/2 | N=48 | Completed | Sponsor: Medical University of South Carolina | Active, not recruiting β Completed
Trial completion β’ Pancreatitis
April 14, 2023
BATMAN: Bronchiectasis Alpha-1 Augmentation Trial- Modulating Airway Neutrophil Function
(clinicaltrials.gov)
- P4 | N=20 | Recruiting | Sponsor: University of Dundee | Trial completion date: Mar 2023 β Oct 2024 | Trial primary completion date: Mar 2023 β Oct 2024
Trial completion date β’ Trial primary completion date β’ Bronchiectasis β’ Pulmonary Disease β’ Respiratory Diseases β’ CTSG β’ ELANE
March 21, 2023
BATMAN: Bronchiectasis Alpha-1 Augmentation Trial- Modulating Airway Neutrophil Function
(clinicaltrials.gov)
- P4 | N=20 | Recruiting | Sponsor: University of Dundee | Not yet recruiting β Recruiting
Enrollment open β’ Bronchiectasis β’ Pulmonary Disease β’ Respiratory Diseases β’ CTSG β’ ELANE
February 27, 2023
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
(clinicaltrials.gov)
- P1/2 | N=16 | Recruiting | Sponsor: Grifols Therapeutics LLC | Trial completion date: Feb 2023 β Mar 2024 | Trial primary completion date: Feb 2023 β Mar 2024
Trial completion date β’ Trial primary completion date β’ Alpha-1 Antitrypsin Deficiency β’ Hepatology β’ Pulmonary Disease β’ Respiratory Diseases
February 17, 2023
SPARTA-OLE: Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency
(clinicaltrials.gov)
- P3 | N=250 | Enrolling by invitation | Sponsor: Grifols Therapeutics LLC | N=192 β 250
Enrollment change β’ Alpha-1 Antitrypsin Deficiency β’ Chronic Obstructive Pulmonary Disease β’ Genetic Disorders β’ Hepatology β’ Pulmonary Disease β’ Pulmonary Emphysema β’ Respiratory Diseases
November 18, 2022
SPARTA-OLE: Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency
(clinicaltrials.gov)
- P3 | N=192 | Enrolling by invitation | Sponsor: Grifols Therapeutics LLC | Recruiting β Enrolling by invitation | Trial completion date: Apr 2024 β Apr 2028 | Trial primary completion date: Apr 2024 β Apr 2028
Enrollment status β’ Trial completion date β’ Trial primary completion date β’ Alpha-1 Antitrypsin Deficiency β’ Chronic Obstructive Pulmonary Disease β’ Genetic Disorders β’ Hepatology β’ Pulmonary Disease β’ Pulmonary Emphysema β’ Respiratory Diseases
November 18, 2022
SPARTA: Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)
(clinicaltrials.gov)
- P3 | N=339 | Recruiting | Sponsor: Grifols Therapeutics LLC | Trial completion date: Jun 2025 β Jun 2026 | Trial primary completion date: Jun 2025 β Jun 2026
Trial completion date β’ Trial primary completion date β’ Alpha-1 Antitrypsin Deficiency β’ Chronic Obstructive Pulmonary Disease β’ Genetic Disorders β’ Hepatology β’ Pulmonary Disease β’ Pulmonary Emphysema β’ Respiratory Diseases
October 17, 2022
BATMAN: Bronchiectasis Alpha-1 Augmentation Trial- Modulating Airway Neutrophil Function
(clinicaltrials.gov)
- P4 | N=20 | Not yet recruiting | Sponsor: University of Dundee
New P4 trial β’ Bronchiectasis β’ NonβCystic Fibrosis Bronchiectasis β’ Pulmonary Disease β’ Respiratory Diseases β’ CTSG β’ ELANE
September 21, 2022
SPARTA-OLE: Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency
(clinicaltrials.gov)
- P3 | N=192 | Recruiting | Sponsor: Grifols Therapeutics LLC | Active, not recruiting β Recruiting
Enrollment open β’ Alpha-1 Antitrypsin Deficiency β’ Chronic Obstructive Pulmonary Disease β’ Genetic Disorders β’ Hepatology β’ Pulmonary Disease β’ Pulmonary Emphysema β’ Respiratory Diseases
August 18, 2022
Long-term safety of Prolastin®-C, an alpha1-proteinase inhibitor, in Japanese patients with alpha1-antitrypsin deficiency.
(PubMed, Respir Investig)
- P1/2 | "Long-term weekly intravenous infusions of 60 mg/kg Alpha-1 MP are generally safe and well-tolerated in Japanese patients with AATD."
Journal β’ Alpha-1 Antitrypsin Deficiency β’ Chronic Obstructive Pulmonary Disease β’ Hepatology β’ Immunology β’ Pulmonary Disease β’ Respiratory Diseases
May 06, 2022
High-level production of wild-type and oxidation-resistant recombinant alpha-1-antitrypsin in glycoengineered CHO cells.
(PubMed, Biotechnol Bioeng)
- "Using the CR5 promoter, glycoengineered stable CHO pools were able to produce over 2.1 g/L and 2.8 g/L of wild-type and mutein forms of A1AT, respectively, with N-glycans analogous to the plasma-derived clinical product Prolastin-C...These purified recombinant A1AT proteins showed in vitro inhibitory activity equivalent to Prolastin-C and substitution of methionine residues 351 and 358 with valines rendered A1AT significantly more resistant to oxidation. The recombinant A1AT mutein bearing an improved oxidation-resistance described in this study could represent a viable biobetter drug, offering a safe and more stable alternative for augmentation therapy."
Journal β’ Alpha-1 Antitrypsin Deficiency β’ Chronic Obstructive Pulmonary Disease β’ Immunology β’ Pulmonary Disease β’ Pulmonary Emphysema β’ Respiratory Diseases β’ ELANE β’ ST6GAL1
April 19, 2022
Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19)
(clinicaltrials.gov)
- P2 | N=54 | Terminated | Sponsor: Grifols Therapeutics LLC | N=100 β 54 | Recruiting β Terminated; Study Stopped for Futility
Enrollment change β’ Trial termination β’ Infectious Disease β’ Novel Coronavirus Disease β’ Respiratory Diseases β’ CRP
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