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

Phase 4

Completed

• Conditions: ITP
• Interventions: Drug: TPO

• Registration Number: NCT04089267
• Lead Sponsor: 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

Study Timeline

• Study Start: 2016-12
• Primary Completion: 2018-12
• Study Completion: 2019-08
• Status Verified: 2019-09
• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-12
• Last Update Submitted: 2019-09-12
• Study First Posted: 2019-09-13
• Last Update Posted: 2019-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group 1	TPO	rhTPO injection7500 U ;one time a day; 14 times of administration
experimental group 2	TPO	rhTPO injection15000 U;one time a day;14 times of administration
experimental group 3	TPO	rhTPO injection15000 U;1 time every other day, 7 times;
experimental group 4	TPO	rhTPO injection30000 U；1 time every other day, 7 times;

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
AUCss	up to 28days
Cav	up to 28days	average Blood concentration at steady state Blood concentration at steady state Blood concentration at steady state
the total effective rate of treatment in ITP patients on day 7 and day 28	for day7and day28
AE	up to 28days
The change in Platelet count from baseline on day 7 and day28 after the first dose	for day7and day28
Incidence of anti-rhTPO antibodies	up to 28days

Trial Locations

Locations (21)

Xinxiang Central Hospital,; 🇨🇳 Xinxiang, China

renmin Hospital of Wuhan University Hubei General Hospital; 🇨🇳 Wuhan, Hubei, China

Loudi Central Hospital; 🇨🇳 Loudi, Hunan, China

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

The First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

Guangzhou Panyu Central Hospital; 🇨🇳 Guangzhou, Guangdong, China

Harbin Institute of Hematology and Oncology; 🇨🇳 Haerbin, Heilongjiang, China

Lishui City Center Hospital; 🇨🇳 Lishui, Zhejiang, China

First Affiliated Hospital Heilongjiang University of Chinese Medicine; 🇨🇳 Shenyang, Liaoning, China

Xi An Central Hospital; 🇨🇳 Xi'an, Shanxi, China

Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

The First Affiliated Hospital of Xinjiang Medical University; 🇨🇳 Xinjiang, 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

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

The Second Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China

Chinese Academy of Medical Sciences Blood Disease Hospital; 🇨🇳 Tianjin, Tianjin, China

Xinjiang Uygur Autonomous Region Chinese Medicine Hospital,; 🇨🇳 Urumqi, Xinjiang, China