Herombopag + rhTPO in Severe Immune Thrombocytopenia

Immune Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05328804
• Other study ID #: SZ-ITP01
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2022
• Source: The First Affiliated Hospital of Soochow University
• Contact: Hong Tian
• Phone: 15850150032
• Email: tianhong0718[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Male or female,70 =age=18;

2. Diagnosed as primary immune thrombocytopenia;

3. Platelet count was less than 10 × 10E9 / L with active bleeding, or bleeding score = 5 points;

4. No use of IVIG, Avatrombopag, Eltrombopag or Romiplostim 2 weeks before treatment;

5. Rituximab was used for at least 2 months, and other immunosuppressants were stable for at least 4 weeks.

6. There was no history of platelet transfusion one week before treatment.

Exclusion Criteria:

1. Secondary thrombocytopenia caused by other autoimmune diseases and virus infection was excluded;

2. Patients with active malignant tumors, pregnancy, severe cardiovascular, cerebrovascular diseases and a history of arteriovenous thrombotic diseases were excluded;

3. Patients deemed unsuitable for enrollment by the investigator;

4. Patients with thrombotic disease or serious uncontrolled cardiovascular and cerebrovascular disease;

5. Patients reject to participate in the study.

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• rhTPO
subcutaneous injection
• Herombopag
Orally by mouth

Locations

Country	Name	City	State
China	Jie Yin	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yin Jie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate	platelets =30*10E9/L, and at least 2 times higher than the baseline platelet count, and there is no hemorrhagic manifestations	From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
Primary	The rate and magnitude of the increase in platelet count	The rate and magnitude of the increase in platelet count after treatment	From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
Primary	Platelet maintenance response time	Platelets stay above 30*10E9/L	From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
Secondary	Platelet fuction	Platelet aggregation function assay and the expression of P selectin on platelet surface	From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
Secondary	the markers of thrombosis and fibrinolysis	platelet-derived microparticals in plasma, concentration of Plasminogen Activator Inhibitor-1 (PAI-1), D-D dimer, tissue plasminogen activator (tPA),urokinase-type plasminogen activator (uPA) and Thrombin activatable fibrinolysis inhibitor (TAFI)	From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment
Secondary	Thrombotic events	the number/time/site of thrombotic events (lower extremity deep vein thrombosis, pulmonary embolism, intracranial thrombosis, .etc)in participants	From randomization to 3 months after rhTPO/Herombopag/Herombopag+rhTPO treatment