Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Jiangsu Hengrui Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Elderly ITP patients have many underlying diseases, hormone contraindications and many adverse reactions during the use of hormones. TPO-RAs are oral small-molecule non-peptide drugs. Retrospective studies have shown that they have good efficacy and high safety in elderly patients. Therefore, this study is a prospective trial to evaluate TPO-RAs as the first-choice drug for the treatment of elderly ITP patients with contraindications to hormones, aiming to improve the efficacy-risk ratio of elderly patients
Primary immune thrombocytopenia (ITP) is an immune disorder characterized by decreased production and increased destruction of platelets. In recent years, with the in-depth exploration of its pathogenesis and the continuous influx of new drugs, the status of second-line treatment drugs, mainly TPO receptor agonists (TPO-RAs), has been continuously improved, which has brought great importance to the treatment and management of ITP patients. However, for elderly ITP patients with severe underlying diseases, poor hormone tolerance, severe adverse reactions or hormone contraindications, whether TPO receptor agonists can be used as the first-choice drug and its efficacy and safety are still lacking relevant research, and for elderly ITP patients There is a lack of uniform guidelines for the treatment and management of patients. Limited retrospective studies have shown that TPO receptor agonists have good safety and efficacy, and are expected to become the recommended drugs for the treatment of elderly patients with ITP. However, whether TPO receptor agonists can be directly used as the first-choice drug for newly diagnosed elderly ITP patients who are not suitable for first-line treatment and its efficacy are uncertain.
This study will include newly diagnosed elderly ITP patients with hormonal contraindications or potential serious side effects of hormonal therapy, take the TPO-RA drug hetropoda as the first-choice treatment drug, and explore the effectiveness of hetrompopag in such patients and safety analysis. This study will provide new ideas and clinical basis for standardized and individualized treatment of elderly ITP patients, and provide practical experience for promoting the establishment of elderly ITP treatment guidelines.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2.5mg/d | Experimental | After the subjects signed the informed consent and passed the screening, they entered the treatment period and received a starting dose of 2.5 mg/d of Hetrabopag. During the treatment process, the clinician adjusted the drug dose according to the patient's own conditions. The maximum drug dose was 7.5 mg qd, 28 d Evaluate efficacy and safety after completion; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2.5mg/d Hetrombopag | Drug | After the subjects signed the informed consent and passed the screening, they entered the treatment period and received a starting dose of 2.5 mg/d of Hytrombopag. During the treatment process, the clinician adjusted the drug dose according to the patient's own conditions. The maximum drug dose was 7.5 mg qd, 28 d Evaluate efficacy and safety after completion; |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response | Proportion of subjects with platelet counts ≥50×10^9/L after 28 days of treatment | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Remission rate | Complete response, effective, ineffective proportion of testers after 28 days of treatment | 28 days |
| Drug efficacy | During treatment, the proportion of subjects, which the platelet count at least once reached ≥50×109/L. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heng Mei, PhD | Contact | 86-13886160811 | 8613986183871 | hmei@hust.edu.cn |
| Min Xu, MD | Contact | 86-13212794115 | 8613986183871 | xu_min1015@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Heng Mei, PhD | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10419881 | Background | Frederiksen H, Schmidt K. The incidence of idiopathic thrombocytopenic purpura in adults increases with age. Blood. 1999 Aug 1;94(3):909-13. | |
| 25305203 | Background | Moulis G, Palmaro A, Montastruc JL, Godeau B, Lapeyre-Mestre M, Sailler L. Epidemiology of incident immune thrombocytopenia: a nationwide population-based study in France. Blood. 2014 Nov 20;124(22):3308-15. doi: 10.1182/blood-2014-05-578336. Epub 2014 Oct 10. |
Not provided
Not provided
the data will share to others if they not involve patient privacy
the data will be shared after the study is completed, it will take 2 years.
Not sure yet
Not provided
Not provided
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000614661 | hetrombopag |
Not provided
Not provided
Not provided
This is a single-arm open-label trial. After enrollment, patients received an initial dose of 2.5 mg of hetropoda for 4 weeks, and blood routine monitoring was performed regularly during treatment.
Not provided
Not provided
Not provided
Not provided
|
|
| 28 days |
| Evaluation of effectiveness | During treatment, the proportion of subjects, which the platelet count increased at least 2 times compared with baseline. | 28 days |
| Adverse events | Evaluate the incidence and severity of bleeding based on the ITP-BAT bleeding score | 6 months from treatment |
| Adverse events | During treatment, the proportion of subjects, which received at least once rescue | 6 months from treatment |
| Side effects of drugs | Assessing safety through the adverse events,such as liver damage, etc. | 1 month from treatment |
| 7898229 | Background | Glynn RJ, Field TS, Rosner B, Hebert PR, Taylor JO, Hennekens CH. Evidence for a positive linear relation between blood pressure and mortality in elderly people. Lancet. 1995 Apr 1;345(8953):825-9. doi: 10.1016/s0140-6736(95)92964-9. |
| 31794604 | Background | Neunert C, Terrell DR, Arnold DM, Buchanan G, Cines DB, Cooper N, Cuker A, Despotovic JM, George JN, Grace RF, Kuhne T, Kuter DJ, Lim W, McCrae KR, Pruitt B, Shimanek H, Vesely SK. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019 Dec 10;3(23):3829-3866. doi: 10.1182/bloodadvances.2019000966. |
| 1984800 | Background | Cortelazzo S, Finazzi G, Buelli M, Molteni A, Viero P, Barbui T. High risk of severe bleeding in aged patients with chronic idiopathic thrombocytopenic purpura. Blood. 1991 Jan 1;77(1):31-3. |
| 24942752 | Background | Ruggeri M, Tosetto A, Palandri F, Polverelli N, Mazzucconi MG, Santoro C, Gaidano G, Lunghi M, Zaja F, De Stefano V, Sartori R, Fazi P, Rodeghiero F; Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) Anemia and Thrombocytopenias Working Party. GIMEMA Study ITP0311. Thrombotic risk in patients with primary immune thrombocytopenia is only mildly increased and explained by personal and treatment-related risk factors. J Thromb Haemost. 2014 Aug;12(8):1266-73. doi: 10.1111/jth.12636. Epub 2014 Jul 16. |
| 21956157 | Background | Michel M, Rauzy OB, Thoraval FR, Languille L, Khellaf M, Bierling P, Godeau B. Characteristics and outcome of immune thrombocytopenia in elderly: results from a single center case-controlled study. Am J Hematol. 2011 Dec;86(12):980-4. doi: 10.1002/ajh.22170. Epub 2011 Sep 28. |
| 18848179 | Background | Daou S, Federici L, Zimmer J, Maloisel F, Serraj K, Andres E. Idiopathic thrombocytopenic purpura in elderly patients: a study of 47 cases from a single reference center. Eur J Intern Med. 2008 Oct;19(6):447-51. doi: 10.1016/j.ejim.2007.07.006. Epub 2008 Feb 20. |
| 22956151 | Background | Zhou H, Fu R, Wang H, Zhou F, Li H, Zhou Z, Zhang L, Yang R. Immune thrombocytopenia in the elderly: clinical course in 525 patients from a single center in China. Ann Hematol. 2013 Jan;92(1):79-87. doi: 10.1007/s00277-012-1567-2. Epub 2012 Sep 6. |
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |