Status:
COMPLETED
The Combination of ATRA and Eltrombopag as the Treatment of Steroid-resistant/Relapse ITP Based on MSC-C5b-9
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Beijing Friendship Hospital
Beijing Tongren Hospital
Conditions:
Purpura, Thrombocytopenic, Idiopathic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A Prospective, Randomized, Open-Label, Multicenter Clinical Trial study to compare the efficacy and safety of ATRA plus eltrombopag compared to eltrombopag monotherapy in the treatment of steroid-resi...
Detailed Description
The investigators are undertaking a parallel group, multicenter, randomized controlled trial of patients with ITP in China. Patients were tested for MSCs, and they were divided into MSC-C5b-9+ group a...
Eligibility Criteria
Inclusion
- 1\. Isolated thrombocytopenia (platelet count \<30 × 109/L); 2. age \> 18 years; 3. normal white blood cells and red blood cells on bone marrow examination; 4. increased number of megakaryocytes (bone marrow examination was performed in all patients except for myelofibrosis or other conditions that can cause thrombocytopenia disease); 5. the spleen was normal in size; 6. Eastern Cooperative Oncology Group status score (ECOG score) ≤ 2; 7. ineffective or relapsed after at least 1 course of full-dose full-course hormone therapy; 8. Failure of prior ITP therapy (eg, hormones, splenectomy, and cyclosporine) and at least 4 weeks from enrollment.
Exclusion
- 1\. Secondary ITP such as drug-related thrombocytopenia; 2. thrombocytopenia due to viral infection (HIV, hepatitis B virus, or hepatitis C virus); 3. severe cardiac, renal, hepatic, or respiratory insufficiency; 4. severe immunodeficiency; 5. pregnancy or lactation; 6. myelodysplasia or Myelofibrosis; 7. history of malignancy; 8. ongoing immunosuppressive therapy for other diseases; 9. patients previously treated with eltrombopag were excluded from this study.
Key Trial Info
Start Date :
October 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT05438875
Start Date
October 12 2022
End Date
November 30 2024
Last Update
September 9 2025
Active Locations (5)
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1
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China, 100010
2
Beijing Tongren hospital
Beijing, Beijing Municipality, China
3
Department of Hematology, Beijing Friendship Hospital, Capital Medical University
Beijing, China
4
Department of Hematology, Beijing Hospital
Beijing, China