Herombopag + rhTPO in Severe Immune Thrombocytopenia

NCT05328804 | Unknown Phase 3

• 1 other identifier: SZ-ITP01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Thrombocytopenia

Keywords

immune thrombocytopenia; severe; Herombopag; recombinant human thrombopoietin

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Platelet maintenance response time

  Platelets stay above 30\*10E9/L

  From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment

Secondary Outcomes (3)

• Platelet fuction

  From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment

• the markers of thrombosis and fibrinolysis

  From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment

• Thrombotic events

  From randomization to 3 months after rhTPO/Herombopag/Herombopag+rhTPO treatment

Study Arms (3)

rhTPO

EXPERIMENTAL

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

Drug: rhTPO

Herombopag

EXPERIMENTAL

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

Drug: Herombopag

Herombopag in combination of rhTPO

EXPERIMENTAL

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

Drug: rhTPO; Drug: Herombopag

Interventions

rhTPO DRUG

subcutaneous injection

Herombopag in combination of rhTPO; rhTPO

Herombopag DRUG

Orally by mouth

Herombopag; Herombopag in combination of rhTPO

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female,70 ≥age≥18；
• Diagnosed as primary immune thrombocytopenia；
• Platelet count was less than 10 × 10E9 / L with active bleeding, or bleeding score ≥ 5 points；
• No use of IVIG, Avatrombopag, Eltrombopag or Romiplostim 2 weeks before treatment；
• Rituximab was used for at least 2 months, and other immunosuppressants were stable for at least 4 weeks.
• There was no history of platelet transfusion one week before treatment.

You may not qualify if:

• Secondary thrombocytopenia caused by other autoimmune diseases and virus infection was excluded；
• Patients with active malignant tumors, pregnancy, severe cardiovascular， cerebrovascular diseases and a history of arteriovenous thrombotic diseases were excluded；
• Patients deemed unsuitable for enrollment by the investigator；
• Patients with thrombotic disease or serious uncontrolled cardiovascular and cerebrovascular disease;
• Patients reject to participate in the study.

Sponsors & Collaborators

• Yin Jie: lead

Study Sites (1)

Jie Yin

Suzhou, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders

Study Officials

• Jie Yin

  First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Tian

CONTACT

15850150032; tianhong0718@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Model Details: Patients with severe ITP will be randomly assigned to three groups: rhTPO group, Herombopag Group, Herombopag combined with rhTPO group.

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 14, 2022
• Study Start: January 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)