Herombopag + rhTPO in Severe Immune Thrombocytopenia

NCT ID: NCT05328804

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rhTPO

rhTPO will be injected subcutaneously at 300 u/kg daily for 14 days.

Group Type: EXPERIMENTAL

rhTPO

Intervention Type: DRUG

subcutaneous injection

Herombopag

Herombopag will be taken orally at 5 mg daily for 28 days.

Group Type: EXPERIMENTAL

Herombopag

Intervention Type: DRUG

Orally by mouth

Herombopag in combination of rhTPO

Herombopag will be taken orally at 5 mg daily for 28 days，while rhTPO will be injected subcutaneously at 300 u/kg daily for 14 days

Group Type: EXPERIMENTAL

rhTPO

Intervention Type: DRUG

subcutaneous injection

Herombopag

Intervention Type: DRUG

Orally by mouth

Interventions

rhTPO

subcutaneous injection

Intervention Type: DRUG

Herombopag

Orally by mouth

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yin Jie

OTHER

Sponsor Role: lead

Responsible Party

Yin Jie

Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jie Yin

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Soochow University

Locations

Jie Yin

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hong Tian

Role: CONTACT

tianhong0718@163.com

15850150032

Facility Contacts

Jie Yin, MD.，PhD

Role: primary

yinjie@suda.edu.cn

+86-512-67781521

Other Identifiers

SZ-ITP01

Identifier Type: -

Identifier Source: org_study_id