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Analysis of efficacy and safety of different doses of Recombinant Human Thrombopoietin Injection for secondary prevention of CIT: a randomized conntrolled trial.

Analysis of efficacy and safety of different doses of Recombinant Human Thrombopoietin Injection for secondary prevention of CIT

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033659
Enrollment
Unknown
Registered
2020-06-08
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-06-15

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

Conditions

advanced malignancy

Interventions

Group A:the dose of rhTPO is 600U/kg
Group B:the dose of rhTPO is 450U/kg
Group C:the dose of rhTPO is 300U/kg

Sponsors

the third people's hospital of Zhengzhou city
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. For patients with high risk factors of bleeding, the lowest value of platelets after the end of the previous chemotherapy cycle is less than 100x10^9/L or the range of platelets decrease is more than or equal to 50*10^9/L; for those without high risk factors of bleeding, the lowest value of platelets after the end of the previous chemotherapy cycle is less than 75 * 10^9/L or the range of platelets decrease is more than or equal to 50×10^9/L. The high risk factors for bleeding include: (1) Previous bleeding history; (2) Platelet < 75 * 10^9 / L before chemotherapy; (3) Chemotherapy with platinum, gemcitabine, cytarabine, anthracycline and other drugs; (4) Previous radiotherapy, especially for long bone and flat bone (such as pelvis and sternum). 2. Solid tumor patients confirmed by pathology. 3. Willing to participate in the whole research process, follow the research procedure, and give written informed consent before taking any specific steps of the research. 4. The function of heart, liver, lung and kidney is normal. 5. Aged 75-18 years. 6. PS score is 0-2.

Exclusion criteria

Exclusion criteria: 1) The estimated survival time is less than 3 months. 2) Bone marrow infiltration causes thrombocytopenia. 3) Blood disease causes thrombocytopenia. 4) There was a serious disease, which the researchers judged might prevent patients from participating in this study. 5) There was clinical evidence of active bacterial or fungal infection or active viral infection. 6) Poor compliance, unable to participate in the plan setting on time. 7) In the past 12 months, there has been any of the following personal history: syncope due to cardiovascular causes, ventricular tachycardia, ventricular fibrillation or cardiac arrest.

Design outcomes

Primary

MeasureTime frame
Platelet change range;The rate of patients whose platelets return to normal.;

Countries

China

Contacts

Public ContactChen Lu

The Third People's Hospital of Zhengzhou

hnzzchenlu@163.com+86 15937139805

Outcome results

None listed

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