Clinical trial NCT04089267: Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)
Official title: Multicenter, Randomized, Open, Parallel Controlled Trials Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ITP
Lead sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
Sponsor class: INDUSTRY
First posted: 2019-09-13
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a review of the efficacy and safety of different recombinant human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP).

Detailed description: Evaluating the efficacy and safety of different human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP) This trial was designed as a multicenter, randomized, open, parallel controlled study

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old, male or female
* 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:

* pregnant or lactating
* 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.

Primary outcomes:
measure: The change in Platelet count from baseline on day 14 after the first dose
timeFrame: for day 14
measure: Total effective rate of ITP patients on day 14 (V6, D14 ± 1) after the first dose.
timeFrame: for day 14
Secondary outcomes:
measure: The change in Platelet count from baseline on day 7 and day28 after the first dose
timeFrame: for day7and day28
measure: the total effective rate of treatment in ITP patients on day 7 and day 28
timeFrame: for day7and day28
measure: AE
timeFrame: up to 28days
measure: Incidence of anti-rhTPO antibodies
timeFrame: up to 28days
measure: Cav
timeFrame: up to 28days
measure: AUCss
timeFrame: up to 28days
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Second People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Panyu Central Hospital
state: Guangdong
city: Haerbin
country: China
facility: Harbin Institute of Hematology and Oncology
state: Heilongjiang
city: Luoyang
country: China
facility: Henan University of Science and Technology First Affiliated Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou Central Hospital
state: Henan
city: Wuhan
country: China
facility: renmin Hospital of Wuhan University Hubei General Hospital
state: Hubei
city: Loudi
country: China
facility: Loudi Central Hospital
state: Hunan
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: First Affiliated Hospital Heilongjiang University of Chinese Medicine
state: Liaoning
city: Xi'an
country: China
facility: Xi An Central Hospital
state: Shanxi
city: Tianjin
country: China
facility: Chinese Academy of Medical Sciences Blood Disease Hospital
state: Tianjin
city: Urumqi
country: China
facility: Xinjiang Uygur Autonomous Region Chinese Medicine Hospital,
state: Xinjiang
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Lishui
country: China
facility: Lishui City Center Hospital
state: Zhejiang
city: Xinjiang
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
city: Xinxiang
country: China
facility: Xinxiang Central Hospital,
Study officials:
References: