5 completed, 4 terminated. 6 Phase 1, 5 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 6 | Completed 5, Terminated 1 |
| Phase 2 | 5 | Completed 3, Terminated 2 |
| Phase 3 | 1 | Terminated 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 |
|---|---|---|---|---|---|---|
| Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease Trans Sodium Crocetinate, Placebo - Interstitial Lung Disease | Phase 2 | Terminated | Diffusion Pharmaceuticals Inc | 18 | 2021-12-02 | 2022-08-10 |
| Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Trans Sodium Crocetinate in Healthy Volunteers Exercising at Altitude Trans Sodium Crocetinate - Healthy Volunteers With Induced Hypoxia | Phase 1 | Completed | Diffusion Pharmaceuticals Inc | 30 | 2021-11-09 | 2022-04-13 |
| Safety and Efficacy of Trans Sodium Crocetinate (TSC) in Enhancing Tissue Oxygen Levels in Healthy Volunteers Trans-Sodium Crocetinate, Placebo - Healthy Subjects | Phase 1 | Completed | Diffusion Pharmaceuticals Inc | 30 | 2021-03-17 | 2023-07-11 |
| Safety and Efficacy of Trans Sodium Crocetinate (TSC) in SARS-CoV-2 (COVID-19) Infected Subjects Trans Sodium Crocetinate, Normal saline - SARS-CoV-2 (Covid19) | Phase 1 / Phase 2 | Completed | Diffusion Pharmaceuticals Inc | 25 | 2020-09-10 | 2022-04-14 |
| Efficacy and Safety of Trans Sodium Crocetinate (TSC) for Treatment of Suspected Stroke Trans-Sodium Crocetinate, Placebo - Stroke, Acute | Phase 2 | Terminated | Diffusion Pharmaceuticals Inc | 6 | 2019-08-22 | 2021-06-18 |
| Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects Trans Sodium Crocetinate plus SOC, Standard of Care (SOC) - Glioblastoma | Phase 3 | Terminated | Diffusion Pharmaceuticals Inc | 19 | 2018-01-16 | 2021-07-22 |
| Safety and Efficacy of Trans Sodium Crocetinate (TSC) With Radiation and Temozolomide in Newly Diagnosed Glioblastoma Trans Sodium Crocetinate (TSC) - Glioblastoma, GBM | Phase 1 / Phase 2 | Completed | Diffusion Pharmaceuticals Inc | 59 | 2012-02-01 | 2017-07-14 |
| Trans Sodium Crocetinate (TSC) Study of Intra-tumoral Oxygen Concentration, Safety, and Pharmacokinetics in Patients With High Grade Glioma Trans Sodium Crocetinate (TSC) - High Grade Glioma | Phase 1 | Terminated | Diffusion Pharmaceuticals Inc | 1 | 2009-03-01 | 2010-08-12 |
| Safety, Efficacy, and Pharmacokinetics (PK) Study of Trans Sodium Crocetinate (TSC) in Patients With Intermittent Claudication Trans sodium crocetinate (TSC), 0.9% normal saline - Intermittent Claudication | Phase 1 / Phase 2 | Completed | Diffusion Pharmaceuticals Inc | 48 | 2008-08-01 | 2011-07-29 |
Brain Neoplasms (2) · Glioblastoma (2) · Glioma (2) · Atherosclerosis (1) · COVID-19 (1) · Hypoxia (1) · Intermittent Claudication (1) · Lung Diseases, Interstitial (1) · Peripheral Arterial Disease (1) · Stroke (1)
trans-sodium crocetinate (9) · Saline Solution (2) · Sodium Chloride (2) · Standard of Care (1)
United States (8) · Romania (1)
Adrian Streinu Cercel, MD (1) · Andrew Southerland, MD (1) · David R. Jones, M.D. (1) · Harry N Cook, RPH/MBA (1) · Jeffrey Saver, MD (1) · Karen Johnston, MD (1) · Martin K Kankam, MD, PhD (1) · Nerses Sanossian, MD (1)