45 completed, 5 terminated, 4 withdrawn, 3 recruiting. 26 Phase 2, 19 Phase 3, 9 Phase 1, 6 Phase 4, 4 Not applicable.
By phase and status
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|
A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
Alpha-1 15%, Liquid Alpha1-PI - Alpha 1 Antitrypsin Deficiency | Phase 3 | Recruiting | Grifols Therapeutics LLC | 40 | 2026-05-05 | 2026-10-22 |
A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Gamunex-C, Xembify - CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy) | Phase 3 | Recruiting | Grifols Therapeutics LLC | 40 | 2026-04-02 | 2026-10-09 |
A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma
Xembify, Placebo - Hypogammaglobulinemia, Bacterial Infections | Phase 3 | Recruiting | Grifols Therapeutics LLC | 386 | 2022-12-26 | 2026-09-30 |
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
Alpha-1 15%, Liquid Alpha1-Proteinase Inhibitor (Human) - Alpha1-Antitrypsin Deficiency | Phase 1 / Phase 2 | Completed | Grifols Therapeutics LLC | 17 | 2021-12-16 | 2026-10-08 |
A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients
C19-IG 20%, 0.9% Sodium chloride - COVID-19, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection | Phase 3 | Terminated | Grifols Therapeutics LLC | 465 | 2021-04-28 | 2022-12-05 |
Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19)
Liquid Alpha1-Proteinase Inhibitor (Human), Placebo, Standard Medical Treatment - COVID-19 | Phase 2 | Terminated | Grifols Therapeutics LLC | 57 | 2021-01-29 | 2023-03-22 |
Preventing de Novo Portal Vein Thrombosis With Antithrombin-III in Patients With Cirrhosis
Antithrombin III, Placebo - Portal Vein Thrombosis, Cirrhosis, Liver | Phase 1 | Withdrawn | Jonathan Stine | | 2021-01-01 | 2022-03-10 |
A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency
IGSC 20% - Primary Immunodeficiency | Phase 4 | Completed | Grifols Therapeutics LLC | 33 | 2020-11-24 | 2023-09-29 |
Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)
GAMUNEX-C, Standard Medical Treatment - COVID-19 | Phase 2 | Completed | Grifols Therapeutics LLC | 100 | 2020-09-17 | 2022-10-07 |
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency
Gamunex-C, IVIG-PEG - Primary Immunodeficiency | Phase 3 | Completed | Grifols Therapeutics LLC | 33 | 2020-09-02 | 2023-06-05 |
Study Evaluating IGSC 20% Flexible Dosing in Treatment-Experienced and Treatment-Naive Subjects With Primary Immunodeficiency
IGSC 20% daily push versus every 2 weeks pump, IGSC 20% daily push versus once a week pump, IGSC 20% daily push versus 2 times per week pump - Primary Immunodeficiency | Phase 3 | Withdrawn | Grifols Therapeutics LLC | | 2019-12-01 | 2020-04-10 |
Effects of Long-Term Administration of Human Albumin in Participants With Decompensated Cirrhosis and Ascites
Albutein 20%, SMT - Decompensated Cirrhosis and Ascites | Phase 3 | Completed | Grifols Therapeutics LLC | 410 | 2018-07-24 | 2025-06-06 |
Alphanate in Immune Tolerance Induction Therapy
Alphanate - Hemophilia A, Congenital | Phase 2 | Terminated | Grifols Therapeutics LLC | 2 | 2018-01-03 | 2021-11-23 |
Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human)
Immune Globulin (Human) - Anti-Hepatitis A Antibody Levels in Heathy Subjects | Phase 4 | Completed | Grifols Therapeutics LLC | 28 | 2017-10-31 | 2019-07-30 |
Efficacy and Safety of Plasma Exchange With Albutein® 5% in Participants With Amyotrophic Lateral Sclerosis
Albutein 5%, Plasma Exchange - Amyotrophic Lateral Sclerosis | Phase 2 | Completed | Grifols Therapeutics LLC | 12 | 2016-08-29 | 2021-05-05 |
Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE)
Alpha-1 MP - Alpha1-Antitrypsin Deficiency | Phase 1 / Phase 2 | Completed | Grifols Therapeutics LLC | 4 | 2016-07-29 | 2022-03-31 |
Safety and Pharmacokinetics of Alpha-1 MP (Alpha1-proteinase Inhibitor (Human), Modified Process) in Participants With Alpha1-Antitrypsin Deficiency
Alpha-1 MP - Alpha1-Antitrypsin Deficiency | Phase 1 / Phase 2 | Completed | Grifols Therapeutics LLC | 4 | 2016-07-29 | 2021-10-28 |
Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia
Human Plasma-Derived Fibrinogen Concentrate - Congenital Afibrinogenemia | Phase 1 / Phase 2 | Completed | Grifols Therapeutics LLC | 24 | 2016-07-22 | 2022-03-31 |
Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency
Alpha-1 MP - Pulmonary Emphysema in Alpha-1 Antitrypsin Deficiency | Phase 3 | Enrolling by invitation | Grifols Therapeutics LLC | 290 | 2016-07-01 | 2026-06-23 |
Efficacy, Pharmacokinetics, Safety, and Tolerability of IGSC 20% in Subjects With Primary Immunodeficiency
IGSC 20% - Primary Immunodeficiency | Phase 3 | Completed | Grifols Therapeutics LLC | 61 | 2016-06-01 | 2020-06-16 |
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Conditions studied
alpha 1-Antitrypsin Deficiency (13) · Primary Immunodeficiency Diseases (8) · Pulmonary Emphysema (6) · Immunologic Deficiency Syndromes (4) · Agammaglobulinemia (3) · COVID-19 (3) · Emphysema (3) · Hemophilia A (3) · Myasthenia Gravis (3) · Pulmonary Disease, Chronic Obstructive (3) · Cystic Fibrosis (2) · Genetic Diseases, Inborn (2) · Infections (2) · Lung Diseases (2) · Lung Diseases, Obstructive (2)
Interventions
gamma-Globulins (13) · Immunoglobulins, Intravenous (12) · Caprylates (9) · alpha 1-Antitrypsin (8) · Mp alpha1 receptor (7) · Albumins (5) · Saline Solution (5) · Hizentra (4) · Fibrinolysin (3) · Immunoglobulins (3) · Sodium Chloride (3) · factor VIII, von Willebrand factor drug combination (3) · von Willebrand Factor (3) · 15-keto-17-phenyl-18,19,20-trinorprostaglandin F2 alpha-1-isopropyl ester (2) · Antithrombin III (2)
Countries
United States (45) · Canada (15) · Poland (15) · Germany (12) · Spain (11) · France (9) · Hungary (9) · Czechia (8) · Romania (7) · United Kingdom (7) · Australia (6) · Italy (6) · Sweden (6) · Belgium (5) · Denmark (5)
Top investigators
Kim Hanna, MSc (2) · Anthony J Comerota, MD (1) · Asger Dirksen, MD PHD (1) · Charlie Strange, MD (1) · Cliff Librach, MD (1) · David Barth, MD (1) · Erwin Gelfand, MD (1) · Flora Peyvandi, MD (1) · Fred D Lublin, MD (1) · Friedrich Kueppers, MD (1) · James Bussel, MD (1) · James Stocks, MD (1) · Jeffrey Saver, MD (1) · Kecia Courtney (1) · Kerry Morrone, MD (1)
Results publications
PMID 30658914, PMID 32554534, PMID 35350948, PMID 17050563, PMID 18178525, PMID 18645164, PMID 19196813, PMID 19218820, PMID 19251783, PMID 19260050, PMID 19365055, PMID 19483042, PMID 19496683, PMID 19678952, PMID 20457948, PMID 20634190, PMID 20647554, PMID 20837852, PMID 20920295, PMID 20920370, PMID 21617168, PMID 23226015, PMID 25090414, PMID 25727857, PMID 27342758, PMID 29983597, PMID 30416054, PMID 30905652, PMID 31069128, PMID 31621458, PMID 32301062, PMID 33244872, PMID 35877927, PMID 35970714, PMID 36270895, PMID 36936402
NIH funding
2008 (2), 2015 (2), 2016 (1), 2025 (1)