Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)
NCT ID: NCT04089267
Last Updated: 2019-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
288 participants
INTERVENTIONAL
2016-12-31
2019-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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experimental group 1
rhTPO injection7500 U ;one time a day; 14 times of administration
TPO
experimental group 2
rhTPO injection15000 U;one time a day;14 times of administration
TPO
experimental group 3
rhTPO injection15000 U;1 time every other day, 7 times;
TPO
experimental group 4
rhTPO injection30000 U；1 time every other day, 7 times;
TPO
Interventions
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TPO
Eligibility Criteria
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Inclusion Criteria
* For patients who have been diagnosed with ITP, the diagnostic criteria are consistent with the Chinese Expert Consensus on Diagnosis and Treatment of Primary Immune Thrombocytopenia (2016 Edition)
* Recurrence after previous treatment with glucocorticoids is ineffective or effective
* No contraindications to rhTPO (Terbyus) application, and willing to accept rhTPO treatment
* Platelet count before enrollment ≤ 30 × 109 / L, or \> 30 × 109 / L but with active bleeding
* Volunteer to participate in the study and sign the informed consent form
Exclusion Criteria
* Those with a history of thrombosis
* severe cardiopulmonary liver and kidney dysfunction: creatinine level ≥ 176.8μmol / l (2mg / dl), transaminase, bilirubin levels higher than the upper limit of the normal value of 3 times
* Those who have used rhTPO in the past 2 weeks, or who have undergone splenectomy within 2 months, or who have been treated with danazol for less than 1 month, or have recently applied the following ITP treatments but have not yet reached the efficacy judgment time. : C-ball (7 days), vincristine or vinblastine amide or rhIL-11 (2 weeks), Eltrombopag (1 month), or rituximab (2 months)
* In the case of previous treatment of rhTPO: rhTPO 300U/kg/d, 14 days of treatment is invalid;
* Severe or uncontrollable infections
* have a history of mental illness
* The investigator believes that the patient is not eligible to participate in any other circumstances of the trial.
18 Years
ALL
No
Sponsors
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Shenyang Sunshine Pharmaceutical Co., LTD.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Guangdong Second People's Hospital
Guangzhou, Guangdong, China
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, China
Harbin Institute of Hematology and Oncology
Haerbin, Heilongjiang, China
Henan University of Science and Technology First Affiliated Hospital
Luoyang, Henan, China
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
renmin Hospital of Wuhan University Hubei General Hospital
Wuhan, Hubei, China
Loudi Central Hospital
Loudi, Hunan, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
First Affiliated Hospital Heilongjiang University of Chinese Medicine
Shenyang, Liaoning, China
Xi An Central Hospital
Xi’an, Shanxi, China
Chinese Academy of Medical Sciences Blood Disease Hospital
Tianjin, Tianjin Municipality, China
Xinjiang Uygur Autonomous Region Chinese Medicine Hospital,
Ürümqi, Xinjiang, China
Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Lishui City Center Hospital
Lishui, Zhejiang, China
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, , China
Xinxiang Central Hospital,
Xinxiang, , China
Countries
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Other Identifiers
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3sbio-TPO-403
Identifier Type: -
Identifier Source: org_study_id
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