9 completed, 1 terminated. 4 Phase 2, 4 Phase 3, 1 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 4 | Completed 3, Terminated 1 |
| Phase 3 | 4 | Completed 4 |
| Phase 1 | 1 | Completed 1 |
| Phase 4 | 1 | Completed 1 |
Follow Caprylates: new trials by email Literature Review of Caprylates trials Research Report on Caprylates
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 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 |
| The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes IGIV-C, 0.9% Sodium Chloride - Diabetes Complications, Diabetes Mellitus | Phase 2 | Terminated | Beth Israel Deaconess Medical Center | 13 | 2017-09-11 | 2024-05-07 |
| 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 |
| Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency IGIV-C 10%, IGSC 20% - Primary Immunodeficiency | Phase 3 | Completed | Grifols Therapeutics LLC | 53 | 2016-01-01 | 2019-10-04 |
| An Open-label, Single-Arm Study to Evaluate the Safety and Rabies Virus Antibody Titers of Intramuscularly Administered Rabies Immune Globulin (Human) RIG-C - Rabies | Phase 1 | Completed | Grifols Therapeutics LLC | 12 | 2014-03-01 | 2014-07-24 |
| Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified, Albumin (Human) 25%, United States Pharmacopeia (USP) - Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Phase 3 | Completed | Grifols Therapeutics LLC | 117 | 2004-04-01 | 2016-03-23 |
| Use of Immune Globulin Intravenous (Human) To Treat Age-Related Macular Degeneration Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified, Albumin (Human) 25%, United States Pharmacopeia (USP) - Macular Degeneration | Phase 2 | Completed | Grifols Therapeutics LLC | 96 | 2004-01-01 | 2016-03-21 |
| Rapid Infusion Of Immune Globulin Intravenous (IGIV) In Patients With ITP Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified - Purpura, Thrombocytopenic, Idiopathic | Phase 2 | Completed | Grifols Therapeutics LLC | 8 | 2003-07-01 | 2016-04-27 |
| Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified, Albumin (Human) 25%, United States Pharmacopeia (USP) - Multiple Sclerosis, Relapsing-Remitting | Phase 2 | Completed | Grifols Therapeutics LLC | 128 | 2002-12-01 | 2016-04-27 |
| Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified, Dextrose, 5% in Water - Immunologic Deficiency Syndrome, Agammaglobulinemia | Phase 3 | Completed | Grifols Therapeutics LLC | 100 | 2002-08-01 | 2009-09-25 |
Primary Immunodeficiency Diseases (4) · Immunologic Deficiency Syndromes (2) · Agammaglobulinemia (1) · Common Variable Immunodeficiency (1) · Diabetes Complications (1) · Diabetes Mellitus (1) · Diabetic Neuropathies (1) · Immune System Diseases (1) · Macular Degeneration (1) · Multiple Sclerosis, Relapsing-Remitting (1) · Polyradiculoneuropathy, Chronic Inflammatory Demyelinating (1) · Purpura, Thrombocytopenic (1) · Purpura, Thrombocytopenic, Idiopathic (1) · Rabies (1) · Severe Combined Immunodeficiency (1)
Grifols Therapeutics LLC (9) · Beth Israel Deaconess Medical Center (1)
United States (8) · Canada (4) · Germany (4) · Czechia (3) · Poland (3) · Hungary (2) · Israel (2) · Sweden (2) · United Kingdom (2) · Argentina (1) · Australia (1) · Austria (1) · France (1) · Greece (1) · Italy (1)
Christopher Gibbons, MD (1) · Erwin Gelfand, MD (1) · Fred D Lublin, MD (1) · James Bussel, MD (1) · Norman Latov, MD (1) · Richard Brunner, MD (1)
PMID 18178525, PMID 18645164, PMID 19260050, PMID 19365055, PMID 19496683, PMID 20457948, PMID 20647554, PMID 20837852, PMID 29983597, PMID 31621458
2015 (1)