Multiple clinical trials investigate therapeutic strategies for immune thrombocytopenia, primary immune thrombocytopenia, and related hematologic blood platelet disorders. These studies span Phase 1, Phase 2, and Phase 4 designs alongside observational cohort protocols, with recruitment status ranging from active participant enrollment to preparation prior to study initiation. Prominent trial sponsors include industry developers such as Hutchmed alongside academic medical centers, specifically the Institute of Hematology & Blood Diseases Hospital in China and affiliated regional hospitals.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06291415 | Recruiting | Immune Thrombocytopenia|Blood Platelet Disorder|Hematologic Diseases|Purpura Thrombocytopenic|Purpura|Blood Coagulation Disorder|Thrombotic Microangiopathies|Hemorrhagic Disorders|Autoimmune Diseases|Immune System Diseases|Hemorrhage|Pathologic Processes|Skin Manifestations|Thrombocytopenia|Purpura Thrombocytopenic Idiopathic|Primary Immune Thrombocytopenia|ITP - Immune Thrombocytopenia |
Hutchmed |
2024-04-02 | Phase 1 |
| NCT06287567 | Not yet recruiting | Idiopathic Thrombocytopenic Purpura|Immune Thrombocytopenia |
Institute of Hematology & Blood Diseases Hospital China |
2024-03-20 | Phase 4 |
| NCT06281327 | Recruiting | Immune Thrombocytopenia|Treatment |
Institute of Hematology & Blood Diseases Hospital China|Henan Cancer Hospital|Tianjin Medical University Second Hospital|Tianjin Children''s Hospital|The Second Affiliated Hospital of Kunming Medical University |
2024-03 | Phase 2 |
| NCT06094881 | Recruiting | Immune Thrombocytopenia|Treatment |
Institute of Hematology & Blood Diseases Hospital China |
2023-12 | Phase 2 |
| NCT06168851 | Recruiting | Immune Thrombocytopenia|Treatment |
Institute of Hematology & Blood Diseases Hospital China |
2023-12-28 | Phase 2 |
| NCT06107582 | Recruiting | Primary Immune Thrombocytopenia |
Institute of Hematology & Blood Diseases Hospital China|Beijing Children''s Hospital|Tianjin People''s Hospital|Henan Cancer Hospital|Tianjin Medical University Second Hospital|The First Affiliated Hospital of Xiamen University|The Second Affiliated Hospital of Kunming Medical University |
2023-11-01 | -- |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Inosine 5′-triphosphate trisodium salt Solubility in DMSO
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- Inosine 5′-triphosphate trisodium salt Chemical Structure (2D and 3D)
- Inosine 5′-triphosphate trisodium salt SDS|MSDS