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A Multicenter Controlled Trial of Prednisone plus recombinant human thrombopoietin (rhTPO) versus Prednisone plus Immunoglobulin in the Treatment for Primary Thrombocytopenia

A Multicenter Controlled Trial of Prednisone plus recombinant human thrombopoietin (rhTPO) versus Prednisone plus Immunoglobulin in the Treatment for Primary Thrombocytopenia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-15007523
Enrollment
Unknown
Registered
2015-10-27
Start date
2014-10-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Immune Thrombocytopenia

Interventions

Study group:prednisone 1mg/Kg/d, 4 weeks plus recombinant human thrombopoietin (rhTPO) 300U/Kg once a day, total 14 days
Control group:prednisone 1mg/Kg/d, 4 weeks plus Immunoglobulin 400mg/Kg/d, 5days

Sponsors

Rui Jin hospital affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 75, male or female; 2. Primary ITP patients diagnosed with Chinese Consensus on the Diagnosis and Treatment for Adult Immunothrombocytopenia (2012 Edition), or who have been diagnosed ITP but not yet treated; 3. Platelet count below 30*10^9/L twice in succession (not inspected in the same day); meet at least one of the following criteria: 1) platelet count below 10*10^9/L twice in succession (not inspected in the same day); 2) Obvious bleeding tendency; 4 Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or nursing women; 2. History of platelet disorders; 3. Severe heart, lung, liver or kidney dysfunction; 4. Severe or uncontrolled infection; 5. HCV, HBV, or HIV carriers or patients; 6. Psychiatric history; 7. Contraindications for prednisone or immunoglobulin; 8. Other situations not approved by researchers.

Design outcomes

Primary

MeasureTime frame
Platelet count;WHO bleeding score;Serum TPO concentration;Serum TPO antibody;

Countries

China

Contacts

Public ContactJunmin Li
lijunmin@medmail.com.cn+86 021-64370045-665258

Outcome results

None listed

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