High-dose Use of rhTPO in CIT Patients

NCT03633019 | Unknown Phase 4

• 1 other identifier: XJTU1AF2018LSK-056
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thrombocytopenia

Keywords

thrombocytopenia; rhTPO; real-world study; safety; efficacy

Outcome Measures

Primary Outcomes (1)

• Duration of grade 3 and 4 thrombocytopenia

  Period of time when the platelet counts is lower 75×109/L, days

  From time of randomization to the time of platelet counts recover to 75×109/L and above, assessed up to 20days

Secondary Outcomes (3)

• Adverse event

  From randomization until 2 days after treatment completion or withdrawal of patient, whichever comes first, assessed up to 22days

• Platelets transfusion

  From randomization to the time of platelets transfusion, assessed up to 20days

• platelet count nadir

  From randomization to the time of the lowest value of platelets, assessed up to 20days

Study Arms (1)

high-dose rhTPO

EXPERIMENTAL

rhTPO (300-600U/kg/day), ih, until the platelets increased by 50 x 109/L compared to the baseline or above 100 x 109/L

Drug: rhTPO

Interventions

rhTPO DRUG

high dose rhTPO ih

Also known as: Recombinant Human Thrombopoietin Injection

high-dose rhTPO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Shenyang Pharmaceutical University: collaborator

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Thrombocytopenia

Interventions

Thrombopoietin

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Lingxiao Zhang, doctor

  First Affiliated Hospital of Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingxiao Zhang, doctor

CONTACT

+8618066910386; 514324869@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 16, 2018
• Study Start: September 28, 2018
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2020
• Last Updated: October 30, 2018

Record last verified: 2018-06

Locations

CN (1)