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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04089267
Other study ID # 3sbio-TPO-403
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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