26 completed, 4 terminated, 2 withdrawn. 16 Phase 3, 15 Phase 2, 3 Phase 4, 1 Not applicable, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 16 | Completed 11, Terminated 4, Withdrawn 1 |
| Phase 2 | 15 | Completed 13, Terminated 2 |
| Phase 4 | 3 | Completed 2, Withdrawn 1 |
| Not applicable | 1 | Completed 1 |
| Phase 1 | 1 | Completed 1 |
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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 |
|---|---|---|---|---|---|---|
| Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED). GRF312 5%, Placebo Comparator - Dry Eye Disease | Phase 2 | Completed | Instituto Grifols, S.A. | 103 | 2025-11-03 | 2026-06-16 |
| FIB Grifols Congenital Deficiency for On-demand Treatment and Surgical Prophylaxis FIB Grifols - Congenital Afibrinogenemia, Hypofibrinogenemia | Phase 3 | Withdrawn | Instituto Grifols, S.A. | 2023-12-01 | 2023-10-23 | |
| Do IgG Level Variations in CIDP and MMN Patients Following Initial Intravenous IVIg Treatment Correlate With Ultimate Dosing Multifocal Motor Neuropathy (MMN), Chronic Inflammatory Demyelinating Polyradiculoneuropathy | Completed | Walton Centre NHS Foundation Trust | 20 | 2020-09-28 | 2026-02-17 | |
| Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19 Prolastin, Standard Medical Treatment - COVID-19 | Phase 2 | Completed | Instituto Grifols, S.A. | 100 | 2020-07-29 | 2021-07-08 |
| Study to Evaluate the Safety and Efficacy of High Dose IVIG in Hospitalized Participants With Coronavirus Disease (COVID-19) Intravenous Immune Globulin, Standard Medical Treatment - COVID-19 | Phase 2 | Completed | Instituto Grifols, S.A. | 100 | 2020-06-02 | 2021-03-10 |
| A Study to Evaluate Safety and Efficacy of Convalescent Methylene Blue Treated (MBT) Plasma From Donors Recovered From Coronavirus Disease 2019 (COVID-19) Convalescent anti-SARS-CoV-2 MBT Plasma, Standard Medical Treatment - COVID-19 | Phase 2 | Completed | Instituto Grifols, S.A. | 200 | 2020-04-29 | 2021-03-03 |
| Albumin Replacement Therapy in Septic Shock Albutein® 200 g/L or Plasbumin® 20 - Septic Shock | Phase 3 | Terminated | Jena University Hospital | 440 | 2019-10-21 | 2024-10-28 |
| Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5% SMT + PE-A 5%, Standard Medical Treatment - Acute-On-Chronic Liver Failure | Phase 3 | Terminated | Instituto Grifols, S.A. | 274 | 2019-06-17 | 2026-06-04 |
| A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants Fibrin Sealant Grifols, EVICEL - Excessive Bleeding During Surgery | Phase 3 | Completed | Instituto Grifols, S.A. | 186 | 2019-01-18 | 2023-04-14 |
| 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 |
| HEAL STUDY (Hepatic Encephalopathy and Albumin Study) 25% IV albumin, Placebo - Cirrhosis, Hepatic Encephalopathy | Phase 2 | Completed | Hunter Holmes Mcguire Veteran Affairs Medical Center | 48 | 2018-06-20 | 2022-05-31 |
| 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 |
| Efficacy and Safety of Plasma Exchange With Albumin in Patients With Amyotrophic Lateral Sclerosis Albumin - Amyotrophic Lateral Sclerosis | Phase 2 | Completed | Instituto Grifols, S.A. | 13 | 2014-11-01 | 2020-06-16 |
| Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% Dual Inactivation and Filtration (DIF) in Participants With Post-polio Syndrome Flebogamma® 5% DIF, Placebo - Post-polio Syndrome | Phase 2 / Phase 3 | Terminated | Instituto Grifols, S.A. | 191 | 2014-09-23 | 2025-12-05 |
| Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Surgery Human thrombin, Bovine thrombin - Hemostasis | Phase 2 | Completed | Instituto Grifols, S.A. | 181 | 2013-12-01 | 2017-06-14 |
| Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand Disease plasma-derived FVIII/VWF concentrate - Von Willebrand Disease | Phase 4 | Withdrawn | Grifols Therapeutics LLC | 2013-12-01 | 2026-05-22 | |
| Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries Fibrin Sealant Grifols, Surgicel® - Parenchymous Tissue Surgical Bleeding | Phase 3 | Completed | Instituto Grifols, S.A. | 325 | 2013-03-01 | 2017-02-08 |
| Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Soft Tissue Open Surgeries Fibrin Sealant (FS) Grifols, Surgicel® - Soft Tissue Surgical Bleeding | Phase 3 | Completed | Grifols Biologicals, LLC | 327 | 2012-11-01 | 2017-02-23 |
| Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery Fibrin Sealant Grifols, Manual Compression - Vascular Surgical Bleeding | Phase 3 | Completed | Instituto Grifols, S.A. | 225 | 2012-08-01 | 2017-04-06 |
| A Study to Evaluate Albumin and Immunoglobulin in Alzheimer's Disease Albumin 5%, Albumin 20%, Immunoglobulin - Alzheimer's Disease | Phase 2 / Phase 3 | Completed | Instituto Grifols, S.A. | 347 | 2012-04-19 | 2019-07-31 |
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COVID-19 (3) · Fibrosis (3) · Hepatitis B (3) · Recurrence (3) · Afibrinogenemia (2) · Alzheimer Disease (2) · Ascites (2) · Hepatitis B, Chronic (2) · Plaque, Amyloid (2) · Acute-On-Chronic Liver Failure (1) · Amyotrophic Lateral Sclerosis (1) · Antithrombin III Deficiency (1) · Autoimmune Diseases (1) · Brain Diseases (1) · Bruton type agammaglobulinemia (1)
Albumins (5) · Immunoglobulins, Intravenous (3) · gamma-Globulins (3) · Antithrombin III (1) · Fibrin Tissue Adhesive (1) · Fibrinogen (1) · Immunoglobulins (1) · Plasma Exchange (1) · Thrombin (1) · alpha 1-Antitrypsin (1) · galactosamine-conjugated serum albumin-conjugated-(rhodamine X)20 (1) · hepatitis B hyperimmune globulin (1) · igantibe (1) · zidovudine 5'-monophosphate-mannose-albumin conjugate (1)
Spain (15) · United States (15) · Italy (7) · United Kingdom (6) · Canada (5) · Germany (5) · Hungary (5) · Serbia (5) · France (3) · Russia (3) · Belgium (2) · Bulgaria (2) · Denmark (2) · India (2) · Poland (2)
Vicente Arroyo, MD (2) · Ali Khojasteh, MD (1) · Antoni Mas, MD (1) · Antonio Paez (1) · Flora Peyvandi, MD (1) · Franco Filipponi, Prof. MD (1) · James Holt (1) · Jasmohan Bajaj, MD (1) · Louis Kozloff, MD (1) · Marco Ranucci, MD (1) · Marinos Dalakas, MD (1) · Mark Ballow, MD (1)
PMID 30905652, PMID 38695613, PMID 23102903, PMID 30499734, PMID 31376435, PMID 33287911, PMID 34791571, PMID 35867135, PMID 36152764, PMID 38489186, PMID 38544553, PMID 41712212
2016 (2), 2018 (2)