High-dose Use of rhTPO in CIT Patients

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The research studies the safety and efficacy of high-dose recombinant human TPO in solid tumor patients with moderate or severe thrombocytopenia induced by chemotherapy. Patients with platelet count lower than 50 x 109/L will be enrolled and treated with high-dose rhTPO (300-600U/kg/day) until the platelets increased by 50 x 109/L compared to the baseline or above 100 x 109/L. During the study, the blood routine test will be regularly performed according to the clinical routine (at least once every two days). Finally, the clinical data will be collected and analyzed to validate the efficacy and safety of high-dose rhTPO therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborator: Shenyang Pharmaceutical University

Criteria

Inclusion Criteria:

• patients with malignant solid tumor

• moderate or severe chemotherapy-induced thrombocytopenia, platelet counts less than 50×109/L

• plan to use rhTPO

• be willing to adopt appropriate methods of contraception during the study period and 8 weeks after the end of the study; women of childbearing age must undergo pregnancy tests (serum or urine) within 7 days before entering the study and the result must be negative

• volunteer to participate in the study, sign the informed consent, and cooperate with good compliance

Exclusion Criteria:

• having other diseases that can lead to thrombocytopenia, such as aplastic anemia, myelodysplastic syndrome, leukemia, lymphoproliferative disease, immune thrombocytopenic purpura, thrombotic thrombocytopenic purpura, disseminated intravascular coagulation, thyroid disease, liver cirrhosis, hypersplenism, etc.

• using other non-chemotherapeutic drugs that can cause thrombocytopenia, such as sulfonamides, etc

• with long-term wound or great worry of gastrointestinal bleeding

• with venous thrombosis that need thrombolytic or anticoagulant therapy or high risk of venous thromboembolism

• with infection requiring antibiotic treatment

• History of immunodeficiency, including HIV positive, organ transplantation and other acquired/congenital immunodeficiency disorders

• patients with Hepatitis B(except inactive carrier) or Hepatitis C

• with serious heart disease or cerebrovascular disease

• with heart failure or heart failure history

• with severe anemia that requires long-term use of recombinant human erythropoietin

• congenital thrombocytopenia

• has been used medication for thrombocytopenia

• pregnancy or lactation

• participate in other clinical researchers at the same time

• not suitable to participate in the study in researchers'opinion