10 completed, 3 withdrawn, 2 terminated. 8 Phase 2, 7 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 8 | Completed 5, Withdrawn 2, Terminated 1 |
| Phase 1 | 7 | Completed 5, Terminated 1, Withdrawn 1 |
| Phase 3 | 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 |
|---|---|---|---|---|---|---|
| Safety Study of PP-007 in Subjects With Acute Ischemic Stroke PP-007 (Two doses administered 24±6 hours apart) + SOC (IVT or MT or IVT+MT) - Acute Ischemic Stroke | Phase 1 | Completed | Prolong Pharmaceuticals | 24 | 2024-04-24 | 2025-11-14 |
| Randomized Phase 2, Dose-finding Efficacy, Safety Study of ANF-RHO™ Versus Neulasta® in Chemotherapy-Induced Neutropenia ANF-RHO™, Neulasta® - Chemotherapy-induced Neutropenia | Phase 2 | Terminated | Prolong Pharmaceuticals | 9 | 2017-08-03 | 2019-02-12 |
| A Study of EPEG in Beta Thalassemia Patients EPEG - Beta-Thalassemia | Phase 1 | Completed | Prolong Pharmaceuticals | 6 | 2017-06-28 | 2018-05-25 |
| Study of SANGUINATE™ In the Treatment of Sickle Cell Disease Patients With Vaso-Occlusive Crisis SANGUINATE, Placebo - Anemia, Sickle Cell | Phase 2 | Completed | Prolong Pharmaceuticals | 24 | 2016-11-01 | 2018-05-23 |
| A Study of SANGUINATE for the Treatment of Vaso-occlusive Crisis (VOC) in Adult Sickle Cell Disease Patients SANGUINATE 320 mg/kg, Normal Saline - Anemia, Sickle Cell | Phase 2 | Completed | Prolong Pharmaceuticals | 34 | 2016-07-01 | 2018-05-23 |
| A Phase 1 Safety Study of SANGUINATE™ In Patients With Acute Severe Anemia. SANGUINATE™ - Acute Anemia | Phase 1 | Completed | Prolong Pharmaceuticals | 103 | 2016-03-01 | 2017-06-27 |
| SANGUINATE™ in Sickle Cell Disease Associated Leg Ulcer SANGUINATE - Leg Ulcer | Phase 2 | Completed | Prolong Pharmaceuticals | 10 | 2016-03-01 | 2017-02-28 |
| A Study on SANGUINATE™ for the Reduction of Delayed Graft Function in Kidney Transplant Patients SANGUINATE, Normal Saline - Delayed Function of Renal Transplant | Phase 2 | Withdrawn | Prolong Pharmaceuticals | 2016-02-01 | 2018-05-25 | |
| ANF-Rho in the Treatment of Chronic Neutropenia ANF-Rho - Neutropenia, Severe Chronic | Phase 1 / Phase 2 | Withdrawn | Prolong Pharmaceuticals | 2015-10-01 | 2019-03-06 | |
| Efficacy and Safety of SANGUINATE™ for Reduction of Delayed Graft Function in Patients Receiving a Kidney Transplant SANGUINATE, Normal Saline - Delayed Function of Renal Transplant | Phase 2 / Phase 3 | Completed | Prolong Pharmaceuticals | 60 | 2015-08-01 | 2016-10-27 |
| Study to Assess the Safety and Impact on Humoral Sensitization of SANGUINATE in Patients With End Stage Renal Disease SANGUINATE - Renal Insufficiency, Chronic | Phase 1 | Completed | Prolong Pharmaceuticals | 5 | 2015-06-05 | 2018-05-23 |
| Safety and Pharmacokinetics of SANGUINATE™ in Sickle Cell Disease (SCD) Patients Sickle Cell Disease | Withdrawn | Prolong Pharmaceuticals | 2015-01-01 | 2018-05-24 | ||
| Safety and Effect of SANGUINATE™ Infusion in Patients at Risk of Delayed Cerebral Ischemia (DCI) Following Subarachnoid Hemorrhage (SAH) SANGUINATE™ - Cerebral Ischemia | Phase 2 | Completed | Prolong Pharmaceuticals | 12 | 2014-12-01 | 2016-10-27 |
| Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients SANGUINATE™, Hydroxyurea - Sickle Cell Disease | Phase 1 | Completed | Prolong Pharmaceuticals | 24 | 2013-05-01 | 2014-12-03 |
| An Assessment of the Safety and Pharmacokinetics of Ascending Doses of SANGUINATE™ in Healthy Volunteers. SANGUINATE™, Normal Saline Solution - Drug Safety | Phase 1 | Terminated | Prolong Pharmaceuticals | 2 | 2013-05-01 | 2015-01-06 |
Anemia, Sickle Cell (5) · Anemia (2) · Brain Ischemia (1) · Ischemic Stroke (1) · Leg Ulcer (1) · Neutropenia, severe chronic (1) · Renal Insufficiency, Chronic (1) · Stroke (1) · Subarachnoid Hemorrhage (1) · Vaso-Occlusive Crises (1) · beta-Thalassemia (1)
PEGylated carboxyhemoglobin bovine (11) · Saline Solution (5) · Hydroxyurea (1) · pegfilgrastim (1) · pegylated granulocyte colony-stimulating factor (1)
United States (6) · Panama (3) · Colombia (2) · Dominican Republic (2) · Israel (2) · France (1) · Honduras (1) · Netherlands (1) · Thailand (1)
Hemant Misra, PhD (5) · Abe Abuchowski, PhD (1) · Angel Hernandez, MD (1) · Bassam G Abu Jadweh, MD (1) · Benjamin Brenner, MD (1) · Kenny M Galvez, MD (1) · Kirsten Gruis, MD (1) · Luis F Uribe, MD (1) · Michael N Dirringer, MD (1) · Nestor Sosa, MD (1) · Rajat Dhar, MD (1) · Rosa Real, MD (1)