NCT04214951

A Study of Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia

A Prospective Observational Study of Switching Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Thrombopoietin Receptor Agonists (TPO-ra) are novel treatments for patients with refractory Primary Immune Thrombocytopenia (ITP). Rh-TPO and eltrombopag increase the number of platelets through different mechanism. If there is cross-resistance between 2 drugs for the treatment of adult ITP is still no answer. The purpose of this study is to investigate the efficacy and safety of switching eltrombopag and Rh-TPO in adults with ITP.

Detailed description

Non-interventional study. Patients who fail previous steroids and receive rh-TPO and then switch to EPAG or vice versa will be enrolled. The reason for switch will be recorded. Patients in the rh-TPO group were given rh-TPO 300 U/kg once daily for 21 days, and those in the eltrombopag group were given eltrombopag 50mg once daily for 6 weeks. Rh-TPO and eltrombopag were terminated any time the platelet counts increased above 100 × 10\^9/L in the rh-TPO group and 300 × 10\^9/L in the eltrombopag group. The efficacy, safety, and patient/physician preference will be assessed and compared between the two agents.

Conditions

• Corticosteroid-resistant or Relapsed ITP

Interventions

Type	Name	Description
DRUG	Eltrombopag	Patients will be given eltrombopag 50mg once daily for 6 weeks.
DRUG	Recombinant human thrombopoietin (rh-TPO)	Patients will be given rh-TPO 300 U/kg once daily for 21 days.

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-08-01
• Completion: 2022-12-01
• First posted: 2020-01-02
• Last updated: 2020-10-20
• Results posted: 2020-10-20

Locations

1 site across 1 country: China