11 completed, 2 terminated, 1 enrolling by invitation, 1 no longer available. 11 Phase 2, 6 Phase 3, 2 Phase 1, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 11 | Completed 10, Terminated 1 |
| Phase 3 | 6 | Completed 4, Terminated 2 |
| Phase 1 | 2 | Completed 2 |
| Phase 4 | 2 | Enrolling by invitation 1, Recruiting 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 |
|---|---|---|---|---|---|---|
| Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV) Cytomegalovirus Immune Globulin Intravenous (Human) monthly for three months - Cytomegalovirus, Organ Transplant | Phase 4 | Recruiting | Camille N. Kotton, MD | 80 | 2025-11-27 | 2025-12-22 |
| CytoGam for CMV Infection or Disease in Solid Organ Transplant Recipients Cytogam - Cytomegalovirus (CMV) Infection | Phase 4 | Enrolling by invitation | Fernanda P Silveira, MD, MS | 45 | 2025-06-26 | 2026-08-10 |
| Safety, PK and PD of Kamada Anti-SARS-CoV-2 in COVID-19 Kamada Anti-SARS-CoV-2 - Covid19, Pneumonia, Viral | Phase 1 / Phase 2 | Completed | Kamada, Ltd. | 12 | 2020-08-05 | 2021-01-05 |
| Phase III, Efficacy and Safety of "Kamada-AAT for Inhalation" Alpha 1-Antitrypsin, Placebo - Alpha 1-Antitrypsin Deficiency | Phase 3 | Terminated | Kamada, Ltd. | 98 | 2019-11-25 | 2026-08-12 |
| A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD GLASSIA, methylprednisolone or equivalent steroid, Albumin - Graft Versus Host Disease | Phase 2 / Phase 3 | Terminated | Baxalta now part of Shire | 1 | 2017-04-26 | 2021-01-13 |
| Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies KamRAB - HRIG - Rabies | Phase 3 | Completed | Kamada, Ltd. | 30 | 2016-08-01 | 2021-09-05 |
| Study to Evaluate the Safety and Efficacy of Intravenous Glassia® Treatment in Lung Transplantation GLASSIA® and Institution standard of care (SOC) - Transplantation, Lung Rejection | Phase 2 | Completed | Kamada, Ltd. | 30 | 2016-07-26 | 2021-09-01 |
| Phase II Study to Evaluate the Efficacy and Safety of Glassia® in Type-1 Diabetes Alpha-1 Antitrypsin, Placebo - New Onset Type-1 Diabetes | Phase 2 | Completed | Kamada, Ltd. | 70 | 2014-04-01 | 2018-10-11 |
| Phase II, Safety and Efficacy Study of Kamada-alpha-1-antitrypsin (AAT) for Inhalation" Kamada-AAT for Inhalation, 80mg, Placebo, Kamada-AAT for Inhalation, 160mg - Alpha-1 Antitrypsin Deficiency | Phase 2 | Completed | Kamada, Ltd. | 36 | 2014-04-01 | 2020-01-18 |
| Phase II/III Study of the Safety and Effectiveness of HRIG With Active Rabies Vaccine in Healthy Subjects Active rabies vaccine (US-FDA approved) - Rabies | Phase 2 / Phase 3 | Completed | Kamada, Ltd. | 118 | 2013-04-01 | 2021-09-29 |
| Long Term Treatment Effect of the Safety, Tolerability and Efficacy of AAT in Type 1 Diabetes AAT( Alpha 1 Antitrypsin) - Type 1 Diabetes, Beta Cell Preservation | Phase 2 | Completed | Rabin Medical Center | 12 | 2013-01-01 | 2017-01-11 |
| Study of the Safety and Efficacy of Intravenous Alpha-1 Antitrypsin in Type 1 Diabetes Mellitus Alpha-1 Antitrypsin 40mg (AAT, Glassia®), Alpha-1 Antitrypsin 60mg (AAT, Glassia®), Alpha-1 Antitrypsin 80mg (AAT, Glassia®) - Type 1 Diabetes Mellitus | Phase 1 / Phase 2 | Completed | Kamada, Ltd. | 24 | 2011-06-01 | 2016-06-09 |
| International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients With Emphysema Kamada AAT for inhalation, Placebo - Emphysema | Phase 2 / Phase 3 | Completed | Kamada, Ltd. | 168 | 2009-12-01 | 2019-11-29 |
| Phase II Study of the Safety and Efficacy of Inhaled Alpha-1 Antitrypsin (AAT ) in Cystic Fibrosis Patients Aerosolized, human, plasma-derived Alpha-1 Antitrypsin - Cystic Fibrosis | Phase 2 | Completed | Kamada, Ltd. | 21 | 2007-09-01 | 2016-06-09 |
| Phase II/III Study of an Alpha-1 Proteinase Inhibitor (Kamada-API) in Individuals With Alpha-1 Antitrypsin Deficiency Kamada-API - Alpha 1-Antitrypsin Deficiency | Phase 2 / Phase 3 | Completed | Kamada, Ltd. | 50 | 2007-03-01 | 2007-10-17 |
| Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acute GvHD After Hematopoietic Stem Cell Transplantation (HSCT) Glassia - Acute-graft-versus-host Disease, Steroid Refractory Acute Graft Versus Host Disease | No longer available | Impatients N.V. trading as myTomorrows | 2020-10-05 |
alpha 1-Antitrypsin Deficiency (5) · Diabetes Mellitus, Type 1 (2) · Graft vs Host Disease (2) · Rabies (2) · COVID-19 (1) · Cystic Fibrosis (1) · Cytomegalovirus Infections (1) · Diabetes Mellitus (1) · Emphysema (1) · Pneumonia, Viral (1) · Pulmonary Emphysema (1) · alpha-1-Antitrypsin Deficiency, Autosomal Recessive (1)
alpha 1-Antitrypsin (7) · Inhalation (3) · Albumins (1) · Methylprednisolone (1) · Serum Albumin, Human (1) · alpha 1-antitrypsin-leukocyte elastase complex (1) · cytomegalovirus-specific hyperimmune globulin (1)
United States (7) · Israel (6) · Ireland (2) · Netherlands (2) · Sweden (2) · United Kingdom (2) · Belgium (1) · Canada (1) · Denmark (1) · Finland (1) · Germany (1)
Yael Lebenthal, MD (2) · Camille Kotton, MD, FIDSA, FAST (1) · David Wojciechowski, DO (1) · Eitan Kerem, MD (1) · Fernanda Silveira, MD (1) · Jan Stolk, Prof (1) · Jan Stolk, Professor (1) · Mariana Rachmiel, B.Med.Sc (1) · Mariana Rachmiel, MD (1) · Mark Matson, M.D. (1) · Mordechai Kramer, MD (1) · Robert A Sandhaus, M.D. (1)
PMID 22634621, PMID 23822603, PMID 30236025, PMID 31467115, PMID 37665565