Herombopag + rhTPO in Severe Immune Thrombocytopenia

Sponsor
Yin Jie (Other)
Overall Status
Recruiting
CT.gov ID
NCT05328804
Collaborator
(none)
90
1
3
24
3.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients with severe ITP will be randomly assigned to three groups: rhTPO group, Herombopag Group, Herombopag combined with rhTPO group.Patients with severe ITP will be randomly assigned to three groups: rhTPO group, Herombopag Group, Herombopag combined with rhTPO group.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: rhTPO

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

Drug: rhTPO
subcutaneous injection

Experimental: Herombopag

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

Drug: Herombopag
Orally by mouth

Experimental: 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

Drug: rhTPO
subcutaneous injection

Drug: Herombopag
Orally by mouth

Outcome Measures

Primary Outcome Measures

  1. Response Rate [From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment]

    platelets ≥30*10E9/L, and at least 2 times higher than the baseline platelet count, and there is no hemorrhagic manifestations

  2. The rate and magnitude of the increase in platelet count [From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment]

    The rate and magnitude of the increase in platelet count after treatment

  3. Platelet maintenance response time [From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment]

    Platelets stay above 30*10E9/L

Secondary Outcome Measures

  1. Platelet fuction [From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment]

    Platelet aggregation function assay and the expression of P selectin on platelet surface

  2. the markers of thrombosis and fibrinolysis [From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment]

    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)

  3. Thrombotic events [From randomization to 3 months after rhTPO/Herombopag/Herombopag+rhTPO treatment]

    the number/time/site of thrombotic events (lower extremity deep vein thrombosis, pulmonary embolism, intracranial thrombosis, .etc)in participants

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jie Yin Suzhou Jiangsu China

Sponsors and Collaborators

  • Yin Jie

Investigators

  • Principal Investigator: Jie Yin, First Affiliated Hospital of Soochow University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yin Jie, Physician, The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier:
NCT05328804
Other Study ID Numbers:
  • SZ-ITP01
First Posted:
Apr 14, 2022
Last Update Posted:
Apr 26, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Yin Jie, Physician, The First Affiliated Hospital of Soochow University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2022