Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05311930
Study type Interventional
Source Wuhan Union Hospital, China
Contact Heng Mei, PhD
Phone 86-13886160811
Email hmei@hust.edu.cn
Status Not yet recruiting
Phase Phase 4
Start date May 1, 2022
Completion date December 30, 2024

See also
  Status Clinical Trial Phase
Completed NCT05621330 - Efficacy and Safety of QL0911 in Adult Patients With Chronic Primary Immune Thrombocytopenia Phase 3
Active, not recruiting NCT04278924 - A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia Phase 2
Recruiting NCT06148389 - The Safety and Tolerability of STSA-1301 Subcutaneous Injection in Healthy Subjects Phase 1
Active, not recruiting NCT04812925 - A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia Phase 3
Recruiting NCT06107582 - Longitudinal Cohort of Pediatric Primary Immune Thrombocytopenia (ITP)
Recruiting NCT05371743 - Plasma microRNA Levels and Some Cytokines Expression in Patients With ITP Primary Immune Thrombocytopenic Purpura (ITP)
Not yet recruiting NCT05333861 - An Observational, Multicenter Study to Evaluate the Safety and Effectiveness of Hetrombopag in Patients With ITP or AA
Completed NCT03102593 - A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITP Phase 2
Completed NCT06071520 - Andalusian Experience in the Use of Fostamatinib in Patients With ITP. FOSTASUR Study
Recruiting NCT04949009 - Avatrombopag in the Treatment of Primary Immune Thrombocytopenia(ITP)
Terminated NCT04224688 - A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) Phase 3
Active, not recruiting NCT04225156 - A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP). Phase 3
Completed NCT05551624 - Evaluation of the Effect in Platelet Count of Atorvastatin and N-acetyl Cysteine Early Phase 1
Recruiting NCT05422365 - Intravenous Immunoglobulin (IVIG, Bioven) Efficacy and Safety in Chronic Primary Immune Thrombocytopenia (ITP) in Adults Phase 3
Terminated NCT03275740 - A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347 Phase 1
Terminated NCT04596995 - A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) Phase 3
Terminated NCT04200456 - A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) Phase 3
Recruiting NCT05653219 - A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids Phase 3
Completed NCT01727232 - Efficacy and Safety of Rituximab Given at Fixed Dose (1000 mg on Days 1 and 15) Compared to the Standard Regimen in Adult's Immune Thrombocytopenia N/A
Recruiting NCT03771378 - Efficacy and Safety of rhTPO and Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Phase 4