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- | Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial completion date, Trial primary completion date: 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) - Dec 10, 2023
P1/2, N=16, Recruiting, Sponsor: Grifols Therapeutics LLC
Trial completion date: Nov 2024 --> Mar 2025 | Trial primary completion date: Nov 2024 --> Mar 2025
- | Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial completion date, Trial primary completion date: 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) - Oct 3, 2023
P1/2, N=16, Recruiting, Sponsor: Grifols Therapeutics LLC
Trial completion date: Nov 2024 --> Mar 2025 | Trial primary completion date: Nov 2024 --> Mar 2025 Trial completion date: Mar 2024 --> Nov 2024 | Trial primary completion date: Mar 2024 --> Nov 2024
- |||| Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial completion date, Trial primary completion date: SPARTA-OLE: Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency (clinicaltrials.gov) - Jul 28, 2023
P3, N=250, Enrolling by invitation, Sponsor: Grifols Therapeutics LLC
Trial completion date: Mar 2024 --> Nov 2024 | Trial primary completion date: Mar 2024 --> Nov 2024 Trial completion date: Apr 2028 --> Jul 2028 | Trial primary completion date: Apr 2028 --> Jul 2028
- ||||| Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Enrollment closed: 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) - Jun 23, 2023
P3, N=339, Active, not recruiting, Sponsor: Grifols Therapeutics LLC
Trial completion date: Apr 2028 --> Jul 2028 | Trial primary completion date: Apr 2028 --> Jul 2028 Recruiting --> Active, not recruiting
- | Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial completion: Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis (clinicaltrials.gov) - May 9, 2023
P1/2, N=48, Completed, Sponsor: Medical University of South Carolina
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- | Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial completion date, Trial primary completion date: 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) - Feb 27, 2023
P1/2, N=16, Recruiting, Sponsor: Grifols Therapeutics LLC
Active, not recruiting --> Completed Trial completion date: Feb 2023 --> Mar 2024 | Trial primary completion date: Feb 2023 --> Mar 2024
- ||||| Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Enrollment change: SPARTA-OLE: Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency (clinicaltrials.gov) - Feb 17, 2023
P3, N=250, Enrolling by invitation, Sponsor: Grifols Therapeutics LLC
Trial completion date: Feb 2023 --> Mar 2024 | Trial primary completion date: Feb 2023 --> Mar 2024 N=192 --> 250
- |||| Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial completion date, Trial primary completion date: 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) - Nov 18, 2022
P3, N=339, Recruiting, Sponsor: Grifols Therapeutics LLC
N=192 --> 250 Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Jun 2026
- ||| Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Enrollment status, Trial completion date, Trial primary completion date: SPARTA-OLE: Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency (clinicaltrials.gov) - Nov 18, 2022
P3, N=192, Enrolling by invitation, Sponsor: Grifols Therapeutics LLC
Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Jun 2026 Recruiting --> Enrolling by invitation | Trial completion date: Apr 2024 --> Apr 2028 | Trial primary completion date: Apr 2024 --> Apr 2028
- | Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Journal: Long-term safety of Prolastin®-C, an alpha1-proteinase inhibitor, in Japanese patients with alpha1-antitrypsin deficiency. (Pubmed Central) - Nov 2, 2022
P1/2
Recruiting --> Enrolling by invitation | Trial completion date: Apr 2024 --> Apr 2028 | Trial primary completion date: Apr 2024 --> Apr 2028 Long-term weekly intravenous infusions of 60 mg/kg Alpha-1 MP are generally safe and well-tolerated in Japanese patients with AATD.
- | Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
New P4 trial: BATMAN: Bronchiectasis Alpha-1 Augmentation Trial- Modulating Airway Neutrophil Function (clinicaltrials.gov) - Oct 17, 2022
P4, N=20, Not yet recruiting, Sponsor: University of Dundee
- |||| Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Enrollment open: SPARTA-OLE: Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency (clinicaltrials.gov) - Sep 21, 2022
P3, N=192, Recruiting, Sponsor: Grifols Therapeutics LLC
Long-term weekly intravenous infusions of 60 mg/kg Alpha-1 MP are generally safe and well-tolerated in Japanese patients with AATD. Active, not recruiting --> Recruiting
- | Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Journal: High-level production of wild-type and oxidation-resistant recombinant alpha-1-antitrypsin in glycoengineered CHO cells. (Pubmed Central) - Aug 18, 2022
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.
- | Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Enrollment change, Trial termination: Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19) (clinicaltrials.gov) - Apr 19, 2022
P2, N=54, Terminated, Sponsor: Grifols Therapeutics LLC
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. N=100 --> 54 | Recruiting --> Terminated; Study Stopped for Futility
- |||| Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Enrollment closed, Trial completion date, Trial primary completion date: SPARTA-OLE: Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency (clinicaltrials.gov) - Apr 13, 2022
P3, N=192, Active, not recruiting, Sponsor: Grifols Therapeutics LLC
N=100 --> 54 | Recruiting --> Terminated; Study Stopped for Futility Enrolling by invitation --> Active, not recruiting | Trial completion date: Jul 2027 --> Apr 2024 | Trial primary completion date: Jul 2027 --> Apr 2024
- | Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial completion date: Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis (clinicaltrials.gov) - Apr 4, 2022
P1/2, N=48, Active, not recruiting, Sponsor: Medical University of South Carolina
Enrolling by invitation --> Active, not recruiting | Trial completion date: Jul 2027 --> Apr 2024 | Trial primary completion date: Jul 2027 --> Apr 2024 Trial completion date: Dec 2021 --> Nov 2022
- || Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Enrollment open: 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) - Sep 17, 2021
P1/2, N=16, Recruiting, Sponsor: Grifols Therapeutics LLC
Trial completion date: Dec 2021 --> Nov 2022 Not yet recruiting --> Recruiting
- | Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial initiation date: 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) - Jul 8, 2021
P1/2, N=16, Not yet recruiting, Sponsor: Grifols Therapeutics LLC
Not yet recruiting --> Recruiting Initiation date: May 2021 --> Aug 2021
- Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial completion, Trial completion date, Trial primary completion date: GTI1401-OLEt: Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE) (clinicaltrials.gov) - Jun 15, 2021
P1/2, N=4, Completed, Sponsor: Grifols Therapeutics LLC
Initiation date: May 2021 --> Aug 2021 Active, not recruiting --> Completed | Trial completion date: Jan 2023 --> Feb 2021 | Trial primary completion date: Jan 2023 --> Feb 2021
- || Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial completion date, Trial primary completion date: Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19) (clinicaltrials.gov) - Apr 30, 2021
P2, N=100, Recruiting, Sponsor: Grifols Therapeutics LLC
Active, not recruiting --> Completed | Trial completion date: Jan 2023 --> Feb 2021 | Trial primary completion date: Jan 2023 --> Feb 2021 Trial completion date: Sep 2021 --> Feb 2022 | Trial primary completion date: Apr 2021 --> Nov 2021
- | Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Enrollment closed: Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis (clinicaltrials.gov) - Apr 1, 2021
P1/2, N=48, Active, not recruiting, Sponsor: Medical University of South Carolina
Trial completion date: Sep 2021 --> Feb 2022 | Trial primary completion date: Apr 2021 --> Nov 2021 Recruiting --> Active, not recruiting
- |||| Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial completion date, Trial primary completion date: 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) - Mar 4, 2021
P3, N=339, Recruiting, Sponsor: Grifols Therapeutics LLC
Recruiting --> Active, not recruiting Trial completion date: Nov 2023 --> Jun 2025 | Trial primary completion date: Nov 2023 --> Jun 2025
- |||| Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial completion date, Trial primary completion date: SPARTA-OLE: Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency (clinicaltrials.gov) - Mar 3, 2021
P3, N=250, Enrolling by invitation, Sponsor: Grifols Therapeutics LLC
Trial completion date: Nov 2023 --> Jun 2025 | Trial primary completion date: Nov 2023 --> Jun 2025 Trial completion date: Dec 2025 --> Jul 2027 | Trial primary completion date: Dec 2025 --> Jul 2027
- || Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
New P1/2 trial: 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) - Jan 25, 2021
P1/2, N=16, Not yet recruiting, Sponsor: Grifols Therapeutics LLC
- ||| Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Enrollment open: Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19) (clinicaltrials.gov) - Nov 16, 2020
P2, N=100, Recruiting, Sponsor: Grifols Therapeutics LLC
Trial completion date: Dec 2025 --> Jul 2027 | Trial primary completion date: Dec 2025 --> Jul 2027 Not yet recruiting --> Recruiting
- |||| Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
New P2 trial: Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19) (clinicaltrials.gov) - Sep 14, 2020
P2, N=100, Not yet recruiting, Sponsor: Grifols Therapeutics LLC
- Bevespi Aerosphere (formoterol/glycopyrrolate) / AstraZeneca
[VIRTUAL] Assessment of Pharmaceutical Company and Device Manufacturer Payments to Pulmonologists (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_5125;
The impact of these payments needs to be further investigated. This study provides a first step towards examining influence of payments on practice patterns and behaviors of adult pulmonologists.
- Bevespi Aerosphere (formoterol/glycopyrrolate) / AstraZeneca
Assessment of Pharmaceutical Company and Device Manufacturer Payments to Pulmonologists (PENNSYLVANIA CONVENTION CENTER, Hall D-E (200 Level), Area F) - Mar 15, 2020 - Abstract #ATS2020ATS_7676;
The impact of these payments needs to be further investigated. This study provides a first step towards examining influence of payments on practice patterns and behaviors of adult pulmonologists.
- Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Enrollment closed: GTI1401-OLEt: Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE) (clinicaltrials.gov) - Jul 5, 2019
P1/2, N=4, Active, not recruiting, Sponsor: Grifols Therapeutics LLC
This study provides a first step towards examining influence of payments on practice patterns and behaviors of adult pulmonologists. Enrolling by invitation --> Active, not recruiting
- | Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, Cinryze IV (C1 esterase inhibitor [human] IV) / Takeda
Preclinical, Journal: Glyco-engineered CHO cell lines producing alpha-1-antitrypsin and C1 esterase inhibitor with fully humanized N-glycosylation profiles. (Pubmed Central) - Jun 22, 2019
The work presented here shows the potential of expanding the glyco-engineering toolbox for CHO cells to produce a wider variety of glycoproteins with fully humanized N-glycan profiles. We envision replacing plasma-derived A1AT and C1INH with recombinant versions and thereby decreasing our dependence on human donor blood, a limited and possibly unsafe protein source for patients.
- | Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols
Clinical, Reimbursement, Retrospective data, Journal: Impact of a Health Management Program on Healthcare Outcomes among Patients on Augmentation Therapy for Alpha 1-Antitrypsin Deficiency: An Insurance Claims Analysis. (Pubmed Central) - May 31, 2019
We envision replacing plasma-derived A1AT and C1INH with recombinant versions and thereby decreasing our dependence on human donor blood, a limited and possibly unsafe protein source for patients. These results suggest that comprehensive health management services may improve both clinical and economic outcomes among patients with COPD and AATD who receive augmentation therapy.
- | Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Biomarker, Retrospective data, Journal: Inhibiting the inflammatory injury following myocardial ischemia reperfusion with plasma derived α-1 anti-trypsin: a post-hoc analysis of the VCU-α1RT study. (Pubmed Central) - Mar 16, 2019
P1/2
A single administration of Prolastin C given hours after reperfusion in patients with STEMI led to a significant shorter time-to-peak and area-under-the-curve for CK-MB, despite similar peak CK-MB values. These preliminary data support the hypothesis that Prolastin C shortens the duration of the ischemia-reperfusion injury in patients with STEMI.
- Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial completion date, Trial primary completion date: GTI1401-OLEt: Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE) (clinicaltrials.gov) - Feb 12, 2019
P1/2, N=3, Enrolling by invitation, Sponsor: Grifols Therapeutics LLC
These preliminary data support the hypothesis that Prolastin C shortens the duration of the ischemia-reperfusion injury in patients with STEMI. Trial completion date: Mar 2020 --> Jan 2023 | Trial primary completion date: Mar 2020 --> Jan 2023
- | Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial completion date, Trial primary completion date: 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) - Oct 2, 2018
P3, N=339, Recruiting, Sponsor: Grifols Therapeutics LLC
Trial completion date: Mar 2020 --> Jan 2023 | Trial primary completion date: Mar 2020 --> Jan 2023 Trial completion date: Aug 2021 --> Nov 2023 | Trial primary completion date: Aug 2021 --> Nov 2023
- | Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial completion date, Trial primary completion date: SPARTA-OLE: Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency (clinicaltrials.gov) - Oct 2, 2018
P3, N=250, Enrolling by invitation, Sponsor: Grifols Therapeutics LLC
Trial completion date: Aug 2021 --> Nov 2023 | Trial primary completion date: Aug 2021 --> Nov 2023 Trial completion date: Jul 2023 --> Dec 2025 | Trial primary completion date: Jul 2018 --> Dec 2025
- | Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial termination: Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus (clinicaltrials.gov) - Oct 30, 2017
P2, N=76, Terminated, Sponsor: Grifols Therapeutics Inc.
Active, not recruiting --> Terminated; Wk 52 primary endpoint results would be unaffected by follow-up data so trial was discontinued prior to wk 104. No safety data was collected after wk 52.
- Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial completion: Safety and Pharmacokinetics of Alpha-1 MP (Alpha1-proteinase Inhibitor (Human), Modified Process) in Participants With Alpha1-Antitrypsin Deficiency (clinicaltrials.gov) - Jul 2, 2017
P1/2, N=4, Completed, Sponsor: Grifols Therapeutics Inc.
No safety data was collected after wk 52. Recruiting --> Completed
- Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Enrollment open: GTI1401-OLEt: Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE) (clinicaltrials.gov) - Dec 5, 2016
P1/2, N=3, Enrolling by invitation, Sponsor: Grifols Therapeutics Inc.
Recruiting --> Completed Not yet recruiting --> Enrolling by invitation
- Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
New P1/2 trial: Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis (clinicaltrials.gov) - Oct 27, 2016
P1/2, N=48, Recruiting, Sponsor: Medical University of South Carolina
- || Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial primary completion date: Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus (clinicaltrials.gov) - Oct 17, 2016
P2, N=76, Active, not recruiting, Sponsor: Grifols Therapeutics Inc.
Not yet recruiting --> Enrolling by invitation Trial primary completion date: May 2016 --> Dec 2016
- Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
New P1/2 trial: Safety and Pharmacokinetics of Alpha-1 MP (Alpha1-proteinase Inhibitor (Human), Modified Process) in Participants With Alpha1-Antitrypsin Deficiency (clinicaltrials.gov) - Aug 17, 2016
P1/2, N=3, Recruiting, Sponsor: Grifols Therapeutics Inc.
- Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
New P1/2 trial: GTI1401-OLEt: Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE) (clinicaltrials.gov) - Aug 17, 2016
P1/2, N=3, Not yet recruiting, Sponsor: Grifols Therapeutics Inc.
- |||||||||| Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
New P3 trial: SPARTA-OLE: Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency (clinicaltrials.gov) - Jun 13, 2016
P3, N=250, Enrolling by invitation, Sponsor: Grifols Therapeutics Inc.
- ||| Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Enrollment closed: Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus (clinicaltrials.gov) - Feb 11, 2016
P2, N=76, Active, not recruiting, Sponsor: Grifols Therapeutics Inc.
Trial primary completion date: May 2016 --> Dec 2016 Recruiting --> Active, not recruiting
- || Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial completion: A Study to Assess Safety and PK of Liquid Alpha₁-Proteinase Inhibitor (Human) in Treating Alpha₁-Antitrypsin Deficiency (clinicaltrials.gov) - Feb 2, 2016
P2/3, N=32, Completed, Sponsor: Grifols Therapeutics Inc.
Recruiting --> Active, not recruiting Recruiting --> Completed
- Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Enrollment change, Trial termination: Safety and Efficacy of (?1Proteinase Inhibitor, ?1PI) in HIV Disease (clinicaltrials.gov) - Dec 10, 2014
P2/3, N=12, Terminated, Sponsor: Institute for Human Genetics and Biochemistry
Recruiting --> Completed N=20 --> 12 | Recruiting --> Terminated; Blinded review of the data suggested no significant diferences in outcomes.
- ||| Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
New P2/3 trial: A Study to Assess Safety and PK of Liquid Alpha₁-Proteinase Inhibitor (Human) in Treating Alpha₁-Antitrypsin Deficiency (clinicaltrials.gov) - Nov 4, 2014
P2/3, N=30, Recruiting, Sponsor: Grifols Therapeutics Inc.
- Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific, Aralast NP (alpha 1-antitrypsin) / Omni Bio Pharma, Takeda
Trial completion: VCU-Alpha1RT: Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction (clinicaltrials.gov) - Aug 21, 2014
P1/2, N=10, Completed, Sponsor: Virginia Commonwealth University
N=20 --> 12 | Recruiting --> Terminated; Blinded review of the data suggested no significant diferences in outcomes. Recruiting --> Completed
- |||| Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Enrollment open: Study of Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects With New-Onset Type 1 Diabetes Mellitus (clinicaltrials.gov) - Jul 14, 2014
P2, N=75, Recruiting, Sponsor: Grifols Therapeutics Inc.
Recruiting --> Completed Not yet recruiting --> Recruiting
- | Prolastin-C (human alpha1-proteinase inhibitor IV) / Grifols, OrphanPacific
Trial primary completion date: Safety and Efficacy of (?1Proteinase Inhibitor, ?1PI) in HIV Disease (clinicaltrials.gov) - Jun 27, 2014
P2/3, N=20, Recruiting, Sponsor: Institute for Human Genetics and Biochemistry
Not yet recruiting --> Recruiting Trial primary completion date: Mar 2013 --> Jul 2014