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High-dose Use of rhTPO in CIT Patients (HUrhTPOCITP)

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ClinicalTrials.gov Identifier: NCT03633019
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : October 30, 2018
Sponsor:
Collaborator:
Shenyang Pharmaceutical University
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

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.

Condition or disease Intervention/treatment Phase
Thrombocytopenia Drug: rhTPO Phase 4

Detailed Description:
Chemotherapy-induced thrombocytopenia is a common toxic reaction of chemotherapeutic drugs, which may lead to dose reduction, delay or even termination of chemotherapy. Severe thrombocytopenia may cause bleeding and threaten patient's life. rhIL-11 and rhTPO are the only two drugs approved by China Food and Drug Administration for the treatment of chemotherapy-induced thrombocytopenia. The recommended dosage of rhTPO is 300U/kg. Clinical practice in the real world is full of changes and restraints. In the treatment of thrombocytopenia induced by chemotherapy, the actual dose of rhTPO is often below 300U/kg, due to factors such as Specs, economy and convenience. If the dose of rhTPO is insufficient, it can not give full play to the effect and thus can not achieve the purpose of rapid recovery of platelets. Previous clinical studies observed that the effect of rhTPO depends on the given dose. Dosage in the range of 75U-600U/kg of rhTPO were safe in human. While the 75U/kg dose group had no significant effect on the platelet count elevation, the platelet count in other three dose groups of 150U/kg, 300U/kg and 600U/kg increased by 24%, 32%, and 52% (P < 0.01). This research is a real-world study designed to verify the safety and efficacy of high-dose rhTPO 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) and the clinical data will be collected and analyzed. It is based on the patient's actual condition and the treatment measure is more consistent with the clinical practice. The results of this study are expected to provide new options and references for clinical treatment of thrombocytopenia induced by chemotherapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-dose Use of Recombinant Human Thrombopoietin in Patients With Moderate or Severe Thrombocytopenia Induced by Chemotherapy
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: high-dose rhTPO
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
high dose rhTPO ih
Other Name: Recombinant Human Thrombopoietin Injection




Primary Outcome Measures :
  1. Duration of grade 3 and 4 thrombocytopenia [ Time Frame: From time of randomization to the time of platelet counts recover to 75×109/L and above, assessed up to 20days ]
    Period of time when the platelet counts is lower 75×109/L, days


Secondary Outcome Measures :
  1. Adverse event [ Time Frame: From randomization until 2 days after treatment completion or withdrawal of patient, whichever comes first, assessed up to 22days ]
    Any related adverse event during the study according to NCI-CTCAE 4.03, count

  2. Platelets transfusion [ Time Frame: From randomization to the time of platelets transfusion, assessed up to 20days ]
    Platelets transfusion during the study, number of times

  3. platelet count nadir [ Time Frame: From randomization to the time of the lowest value of platelets, assessed up to 20days ]
    the lowest platelet count



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633019


Contacts
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Contact: Lingxiao Zhang, doctor +8618066910386 514324869@qq.com

Locations
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China, Shaanxi
First Affiliated Hospital of Xian Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Lingxiao Zhang, doctor    +8618066910386    514324869@qq.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Shenyang Pharmaceutical University
Investigators
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Principal Investigator: Lingxiao Zhang, doctor First Affiliated Hospital of Xian Jiaotong University

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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03633019     History of Changes
Other Study ID Numbers: XJTU1AF2018LSK-056
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
thrombocytopenia
rhTPO
real-world study
safety
efficacy
Additional relevant MeSH terms:
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Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases