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A randomized, open-label, single-center controlled trial for the efficacy and safety of recombinant human thrombopoietin injection in the treatment of severe Aplastic Anemia with thrombocytopenia

A randomized, open-label, single-center controlled trial for the efficacy and safety of recombinant human thrombopoietin injection in the treatment of severe Aplastic Anemia with thrombocytopenia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019669
Enrollment
Unknown
Registered
2018-11-21
Start date
2019-01-01
Completion date
Unknown
Last updated
2018-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aplastic anemia,Thrombocytopenia

Interventions

Group 1:Add rhTPO, 300U/kg qd after ATG treatment for 8 weeks
Group 2:Add rhTPO, 300U/kg qod after ATG treatment for 8 weeks

Sponsors

Institute of Hematology, People's Hospital, Peking University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with SAA who consent to ATG/CsA treatment. The diagnostic criteria refer to the 2017 Consensus on Diagnosis and Treatment of Aplastic Anemia [5]: (1) The degree of bone marrow cell proliferation is <25% of normal; if = normal 25% but <50%, the remaining hematopoietic cells should be <30%; (2) blood routine: need to have two of the following three: ANC <0.5×10^9/L; corrected reticulocyte <1% or absolute value <20 × 10^9/L; BPC <20 × 10^9/L; (3) If ANC<0.2×10^9/L is a very heavy aplastic anemia (VSAA); 2. Aged 18 to 65 years old, male or female; 3. Those who can be hospitalized for more than 2 months; 4. There is no obvious abnormality in liver and kidney function (serum urea nitrogen, creatinine, transaminase, bilirubin are = 2.5 times the upper limit of normal); 5. According to the New York Heart Association (NYHA) grading standard, cardiac dysfunction = level 2; 6. Female subjects with fertility were negative for serum pregnancy test (screening period); 7. The patient voluntarily signed a written informed consent form indicating his willingness to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Congenital hematopoietic failure, fanconi anemia; 2. Cytogenetics confirmed patients with abnormal cloning; 3. The HBV DNA detection copy number is greater than 1000/mL, and the serum hepatitis B virus is not cleared; 4. With recent thrombosis or high risk of thrombosis; 5. With serious and uncontrollable infection; 6. Patients with severe heart disease, lung disease, kidney disease, liver disease; 7. Patients with other tumors at the same time; 8. Women during lactation and pregnancy; 9. The investigator believes that the patient is not eligible to participate in any other case of the study.

Design outcomes

Primary

MeasureTime frame
3 months detachment rate of platelet transfusion;

Secondary

MeasureTime frame
TPO concentration;Platelet count;overall response rate;

Countries

China

Contacts

Public ContactJia Jinsong

Institute of Hematology, People's Hospital, Peking University

jiajinsong@163.com+86 13717727956

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026