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

ITP Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04089267
• Other study ID #: 3sbio-TPO-403
• Status: Completed
• Phase: Phase 4
• Start date: December 2016
• Est. completion date: August 2019

Study information

• Verified date: September 2019
• Source: Shenyang Sunshine Pharmaceutical Co., LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: August 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ITP
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• TPO

Locations

Country	Name	City	State
China	Guangdong Second People's Hospital	Guangzhou	Guangdong
China	Guangzhou Panyu Central Hospital	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Harbin Institute of Hematology and Oncology	Haerbin	Heilongjiang
China	Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Lishui City Center Hospital	Lishui	Zhejiang
China	Loudi Central Hospital	Loudi	Hunan
China	Henan University of Science and Technology First Affiliated Hospital	Luoyang	Henan
China	First Affiliated Hospital Heilongjiang University of Chinese Medicine	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
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	renmin Hospital of Wuhan University Hubei General Hospital	Wuhan	Hubei
China	Xi An Central Hospital	Xi'an	Shanxi
China	Zhongshan Hospital Xiamen University	Xiamen	Fujian
China	The First Affiliated Hospital of Xinjiang Medical University	Xinjiang
China	Xinxiang Central Hospital,	Xinxiang
China	The First Affiliated Hospital of Henan University of Traditional Chinese Medicine	Zhengzhou	Henan
China	Zhengzhou Central Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Sunshine Pharmaceutical Co., LTD.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in Platelet count from baseline on day 14 after the first dose		for day 14
Primary	Total effective rate of ITP patients on day 14 (V6, D14 ± 1) after the first dose.		for day 14
Secondary	The change in Platelet count from baseline on day 7 and day28 after the first dose		for day7and day28
Secondary	the total effective rate of treatment in ITP patients on day 7 and day 28		for day7and day28
Secondary	AE		up to 28days
Secondary	Incidence of anti-rhTPO antibodies		up to 28days
Secondary	Cav	average Blood concentration at steady state Blood concentration at steady state Blood concentration at steady state	up to 28days
Secondary	AUCss		up to 28days