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Clinical study for high-dose dexamethasone combined with versus without human recombinant thrombopoietin (rhTPO) in the treatment of newly diagnosed primary immune thrombocytopenia (ITP)

Clinical study for high-dose dexamethasone combined with versus without human recombinant thrombopoietin (rhTPO) in the treatment of newly diagnosed primary immune thrombocytopenia (ITP)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027735
Enrollment
Unknown
Registered
2019-11-24
Start date
2020-01-01
Completion date
Unknown
Last updated
2020-11-02

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

Conditions

Adult newly diagnosed immune thrombocytopenia

Interventions

Study group:Dexamethasone 40mg/d×4d, recombinant human thrombopoietin (rhTPO) 300U/Kg subcutaneous injection, once/d×14d, if PLT>100×109/L or PLT increase =50×109/L during treatment period RhTPO drug
rhTPO and dexamethasone were replaced with prednisone 0.5mg~1mg/kg once a day, 0.2mg/kg per week, and the drug was stopped wit
Control group:Dexamethasone 40mg/d×4d, if the PLT>100×10^9/L or PLT increase =50×10^9/L during the treatment period, dexamethasone was replaced with prednisone 0.5mg~ 1mg/kg orally every day, reduce 0

Sponsors

Department of Hematology, Anhui Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1, between the ages of 18-80, male or female; 2. A newly diagnosed ITP patient diagnosed by bone marrow cytology and excluding other secondary thrombocytopenia caused by the disease; 3. The platelet count < 30x10^9/L at the time of initial diagnosis has or does not show bleeding; 4. ECOG score <= 2 points; 5. No history of mental illness; 6. Voluntary signing of written informed consent.

Exclusion criteria

Exclusion criteria: 1, The patient can not have life-threatening bleeding (such as combined with severe anemia and central nervous system bleeding); 2. Receive chemotherapy, anticoagulation therapy or other drugs that affect platelet count within 3 months before enrollment; 3. Received specific treatment for any second-line ITP (eg, cyclophosphamide, 6-mercaptopurine, vincristine, etc.) within 3 months prior to enrollment; 4. Received high doses of corticosteroids or IVIG within 3 months prior to enrollment; 5. There are other serious diseases (lung, liver or kidney disease) other than ITP. Combined with severe cardiac insufficiency or related diseases that seriously affect heart function (such as unstable angina, congestive heart failure, uncontrolled high blood pressure or arrhythmia). 6. Currently, patients with HIV infection, hepatitis B virus or hepatitis C virus are combined; 7. Female patients who are breast-feeding or pregnant during the study period, who may become pregnant or consider pregnancy; 8. Diagnosed as other autoimmune diseases by medical history and laboratory tests (such as anti-nuclear antibody positive, anti-cardiolipin antibody, lupus anticoagulant positive or direct Coombs test positive); 9. Patients with severe osteoporosis; 10. The investigator believes that patients are not eligible to participate in other situations in this study.

Design outcomes

Primary

MeasureTime frame
Platelet count;

Secondary

MeasureTime frame
ITP International Collaboration Group's bleeding score;

Countries

China

Contacts

Public ContactChangcheng Zheng

Department of Hematology, Anhui Provincial Hospital

zhengchch1123@163.com+86 13956961162

Outcome results

None listed

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