Recently completed and ongoing studies of HbF induction and antisickling agents
| Study title . | Clinical trials #/Phase . | Intervention . | Status . | Primary sponsor . |
|---|---|---|---|---|
| HbF Induction | ||||
| Study of Decitabine and Tetrahydrouridine (THU) in Patients With Sickle Cell Disease | NCT01685515 Phase 1 | Decitabine and Tetrahydrouridine | Ongoing | Cleveland Clinic |
| Decitabine for High-Risk Sickle Cell Disease | NCT01375608 Phase 2 | Decitabine | Suspended | NIH Clinical Center, NHLBI |
| Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers | NCT00004412 Phase 2 | Arginine Butyrate | Complete | Boston Med Ctr |
| Phase 1 Placebo Controlled Study of the Safety, Activity and Pharmacokinetics of HQK-1001 in Healthy Subjects | NCT00717262 Phase 1 | HQK-1001 | Complete | HemaQuest |
| Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HQK-1001 Administered Daily in Patients With Sickle Cell Disease | NCT00842088 Phase 1/2 | HQK-1001 | Complete | HemaQuest |
| A Study of HQK-1001 in Patients With Sickle Cell Disease | NCT01322269 Phase 2 | HQK-1001 | Complete | HemaQuest |
| Effects of HQK-1001 in Patients With Sickle Cell Disease | NCT01601340 Phase 2 | HQK-1001 | Terminated | HemaQuest |
| Study to Determine the Maximum Tolerated Dose, Safety and Effectiveness of Pomalidomide for Patients With Sickle Cell Disease | NCT01522547 Phase 1 | Pomalidomide | Complete | Celgene |
| Hemoglobin-modifying and anti-sickling agents | ||||
| Dose-Escalation Study of SCD-101 in Sickle Cell Disease | NCT02380079 Phase 1 | SCD-101 | Ongoing | Invenux; SUNY-Downstate Med Ctr |
| Safety Study of MP4CO in Adult Sickle Cell Patients | NCT01356485 Phase 1 | MP4CO | Complete | Sangart |
| Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients | NCT01848925 Phase 1 | Sanguinate | Complete | Prolong Pharmaceuticals |
| Study of SANGUINATE™ In the Treatment of Sickle Cell Disease Patients With Vaso-Occlusive Crisis | NCT02411708 Phase 2 | Sanguinate | Ongoing | Prolong Pharmaceuticals |
| A Study of the Efficacy and Safety of ICA-17043 (With or Without Hydroxyurea) in Patients With Sickle Cell Anemia. | NCT00040677 Phase 2 | Senicapoc (ICA-17043) | Complete | Icagen |
| A Stratified Sickle Event Randomized Trial (ASSERT) | NCT00102791 Phase 3 | Senicapoc (ICA-17043) | Terminated (lack of efficacy) | Icagen |
| A Study Evaluating the Long-Term Safety of ICA-17043 in Sickle Cell Disease Patients With or Without Hydroxyurea Therapy | NCT00294541 Phase 3 | Senicapoc (ICA-17043) | Terminated | Icagen |
| A Single Dose Study of the Safety, Blood Levels and Biological Effects of Aes-103 Compared with Placebo in Subjects With Stable Sickle Cell Disease | NCT01597401 Phase 1 | Aes-103 | Complete | Baxalta US |
| Evaluation of Different Dose Regimens of Aes-103 Given for 28 Days to Subjects With Stable Sickle Cell Disease | NCT01987908 Phase 2 | Aes-103 | Terminated | Baxalta US |
| Study title . | Clinical trials #/Phase . | Intervention . | Status . | Primary sponsor . |
|---|---|---|---|---|
| HbF Induction | ||||
| Study of Decitabine and Tetrahydrouridine (THU) in Patients With Sickle Cell Disease | NCT01685515 Phase 1 | Decitabine and Tetrahydrouridine | Ongoing | Cleveland Clinic |
| Decitabine for High-Risk Sickle Cell Disease | NCT01375608 Phase 2 | Decitabine | Suspended | NIH Clinical Center, NHLBI |
| Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers | NCT00004412 Phase 2 | Arginine Butyrate | Complete | Boston Med Ctr |
| Phase 1 Placebo Controlled Study of the Safety, Activity and Pharmacokinetics of HQK-1001 in Healthy Subjects | NCT00717262 Phase 1 | HQK-1001 | Complete | HemaQuest |
| Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HQK-1001 Administered Daily in Patients With Sickle Cell Disease | NCT00842088 Phase 1/2 | HQK-1001 | Complete | HemaQuest |
| A Study of HQK-1001 in Patients With Sickle Cell Disease | NCT01322269 Phase 2 | HQK-1001 | Complete | HemaQuest |
| Effects of HQK-1001 in Patients With Sickle Cell Disease | NCT01601340 Phase 2 | HQK-1001 | Terminated | HemaQuest |
| Study to Determine the Maximum Tolerated Dose, Safety and Effectiveness of Pomalidomide for Patients With Sickle Cell Disease | NCT01522547 Phase 1 | Pomalidomide | Complete | Celgene |
| Hemoglobin-modifying and anti-sickling agents | ||||
| Dose-Escalation Study of SCD-101 in Sickle Cell Disease | NCT02380079 Phase 1 | SCD-101 | Ongoing | Invenux; SUNY-Downstate Med Ctr |
| Safety Study of MP4CO in Adult Sickle Cell Patients | NCT01356485 Phase 1 | MP4CO | Complete | Sangart |
| Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients | NCT01848925 Phase 1 | Sanguinate | Complete | Prolong Pharmaceuticals |
| Study of SANGUINATE™ In the Treatment of Sickle Cell Disease Patients With Vaso-Occlusive Crisis | NCT02411708 Phase 2 | Sanguinate | Ongoing | Prolong Pharmaceuticals |
| A Study of the Efficacy and Safety of ICA-17043 (With or Without Hydroxyurea) in Patients With Sickle Cell Anemia. | NCT00040677 Phase 2 | Senicapoc (ICA-17043) | Complete | Icagen |
| A Stratified Sickle Event Randomized Trial (ASSERT) | NCT00102791 Phase 3 | Senicapoc (ICA-17043) | Terminated (lack of efficacy) | Icagen |
| A Study Evaluating the Long-Term Safety of ICA-17043 in Sickle Cell Disease Patients With or Without Hydroxyurea Therapy | NCT00294541 Phase 3 | Senicapoc (ICA-17043) | Terminated | Icagen |
| A Single Dose Study of the Safety, Blood Levels and Biological Effects of Aes-103 Compared with Placebo in Subjects With Stable Sickle Cell Disease | NCT01597401 Phase 1 | Aes-103 | Complete | Baxalta US |
| Evaluation of Different Dose Regimens of Aes-103 Given for 28 Days to Subjects With Stable Sickle Cell Disease | NCT01987908 Phase 2 | Aes-103 | Terminated | Baxalta US |