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)

Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP)

Sponsors

Lead sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

Source Shenyang Sunshine Pharmaceutical Co., LTD.
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

Overall Status Completed
Start Date December 2016
Completion Date August 2019
Primary Completion Date December 2018
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
The change in Platelet count from baseline on day 14 after the first dose for day 14
Total effective rate of ITP patients on day 14 (V6, D14 ± 1) after the first dose. for day 14
Secondary Outcome
Measure Time Frame
The change in Platelet count from baseline on day 7 and day28 after the first dose for day7and day28
the total effective rate of treatment in ITP patients on day 7 and day 28 for day7and day28
AE up to 28days
Incidence of anti-rhTPO antibodies up to 28days
Cav up to 28days
AUCss up to 28days
Enrollment 288
Condition
Intervention

Intervention type: Drug

Intervention name: TPO

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility
The First Affiliated Hospital of Anhui Medical University | Hefei, Anhui, 230022, China
Zhongshan Hospital Xiamen University | Xiamen, Fujian, 361004, China
The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou, Guangdong, 510260, China
Guangdong Second People's Hospital | Guangzhou, Guangdong, 510317, China
Guangzhou Panyu Central Hospital | Guangzhou, Guangdong, 511400, China
Harbin Institute of Hematology and Oncology | Haerbin, Heilongjiang, 150010, China
Henan University of Science and Technology First Affiliated Hospital | Luoyang, Henan, 471003, China
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine | Zhengzhou, Henan, 450000, China
Zhengzhou Central Hospital | Zhengzhou, Henan, 450007, China
renmin Hospital of Wuhan University Hubei General Hospital | Wuhan, Hubei, 430060, China
Loudi Central Hospital | Loudi, Hunan, 417118, China
The Second Affiliated Hospital of Soochow University | Suzhou, Jiangsu, 215000, China
The First Hospital of China Medical University | Shenyang, Liaoning, 110001, China
First Affiliated Hospital Heilongjiang University of Chinese Medicine | Shenyang, Liaoning, 150040, China
Xi An Central Hospital | Xi'an, Shanxi, 710499, China
Chinese Academy of Medical Sciences Blood Disease Hospital | Tianjin, Tianjin, 300020, China
Xinjiang Uygur Autonomous Region Chinese Medicine Hospital, | Urumqi, Xinjiang, China
Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine | Hangzhou, Zhejiang, 310006, China
Lishui City Center Hospital | Lishui, Zhejiang, 323000, China
The First Affiliated Hospital of Xinjiang Medical University | Xinjiang, China
Xinxiang Central Hospital, | Xinxiang, 453699, China
Location Countries

China

Verification Date

September 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Arm group label: experimental group 1

Arm group type: Experimental

Description: rhTPO injection7500 U ;one time a day; 14 times of administration

Arm group label: experimental group 2

Arm group type: Experimental

Description: rhTPO injection15000 U;one time a day;14 times of administration

Arm group label: experimental group 3

Arm group type: Experimental

Description: rhTPO injection15000 U;1 time every other day, 7 times;

Arm group label: experimental group 4

Arm group type: Experimental

Description: rhTPO injection30000 U;1 time every other day, 7 times;

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov