Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immune Thrombocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Herombopag | Drug | — | UNRESOLVED |
| rhTPO | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- rhTPO
- description
- rhTPO will be injected subcutaneously at 300 u/kg daily for 14 days.
- interventionNames
- Drug: rhTPO
- type
- EXPERIMENTAL
- label
- Herombopag
- description
- Herombopag will be taken orally at 5 mg daily for 28 days.
- interventionNames
- Drug: Herombopag
- type
- EXPERIMENTAL
- label
- Herombopag in combination of rhTPO
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
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