NCT05328804

Herombopag + rhTPO in Severe Immune Thrombocytopenia

Evaluating the Efficacy and Safety of the Combination of Herombopag and Human Thrombopoietin (rhTPO) in the Treatment of Patients With Severe Immune Thrombocytopenia (ITP)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Yin Jie · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Severe immune thrombocytopenia (ITP) is a life-threatening acquired hemorrhagic disease with dramatically decreased platelet number and clinical bleeding symptoms. Some patients with severe ITP did not respond to first-line treatment including steroids and IVIG. It was critical for them to use effective treatments to promote platelet and reduce the risk of fatal bleeding. In this study, the patients with severe ITP will be treated with hetrombopag, rhTPO, and the combination of hetrombopag and rhTPO, respectively. The effect evaluation includes the increase of platelet number and decrease of bleeding scores. Changes of coagulation, platelet activation, fribrinolysis influence, and thrombotic events will also be accessed for the safety of treatments. The aim of this study is to demonstrate that the combination of hetrombopag and rhTPO for severe ITP is more effective than the other two monotherapy and does not increase thrombotic events or thrombosis risk.

Detailed description

Patients with severe ITP will be randomly assigned to three groups: rhTPO group, Herombopag Group, Herombopag combined with rhTPO group. The effective rate of treatment, the rate and amplitude of platelet increase, the response time of platelet maintenance, and the effect of combination therapy on hemostasis will be compared. At the same time, the investigators will analyze the markers of thrombosis and thrombotic events to assess the safety of combination therapy.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	rhTPO	subcutaneous injection
DRUG	Herombopag	Orally by mouth

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-11-30
• Completion: 2023-12-31
• First posted: 2022-04-14
• Last updated: 2022-04-26

Locations

1 site across 1 country: China