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

Sponsor

Shenyang Sunshine Pharmaceutical Co., LTD. (Industry)

Overall Status

Completed

CT.gov ID

NCT04089267

Collaborator

(none)

288

Enrollment

Locations

Arms

Actual Duration (Months)

13.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
ITP	Drug: TPO	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

288 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental group 1 rhTPO injection7500 U ;one time a day; 14 times of administration	Drug: TPO
Experimental: experimental group 2 rhTPO injection15000 U;one time a day;14 times of administration	Drug: TPO
Experimental: experimental group 3 rhTPO injection15000 U;1 time every other day, 7 times;	Drug: TPO
Experimental: experimental group 4 rhTPO injection30000 U；1 time every other day, 7 times;	Drug: TPO

Outcome Measures

Primary Outcome Measures

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

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]
average Blood concentration at steady state Blood concentration at steady state Blood concentration at steady state
AUCss [up to 28days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui	China	230022
2	Zhongshan Hospital Xiamen University	Xiamen	Fujian	China	361004
3	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	510260
4	Guangdong Second People's Hospital	Guangzhou	Guangdong	China	510317
5	Guangzhou Panyu Central Hospital	Guangzhou	Guangdong	China	511400
6	Harbin Institute of Hematology and Oncology	Haerbin	Heilongjiang	China	150010
7	Henan University of Science and Technology First Affiliated Hospital	Luoyang	Henan	China	471003
8	The First Affiliated Hospital of Henan University of Traditional Chinese Medicine	Zhengzhou	Henan	China	450000
9	Zhengzhou Central Hospital	Zhengzhou	Henan	China	450007
10	renmin Hospital of Wuhan University Hubei General Hospital	Wuhan	Hubei	China	430060
11	Loudi Central Hospital	Loudi	Hunan	China	417118
12	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215000
13	The First Hospital of China Medical University	Shenyang	Liaoning	China	110001
14	First Affiliated Hospital Heilongjiang University of Chinese Medicine	Shenyang	Liaoning	China	150040
15	Xi An Central Hospital	Xi'an	Shanxi	China	710499
16	Chinese Academy of Medical Sciences Blood Disease Hospital	Tianjin	Tianjin	China	300020
17	Xinjiang Uygur Autonomous Region Chinese Medicine Hospital,	Urumqi	Xinjiang	China
18	Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310006
19	Lishui City Center Hospital	Lishui	Zhejiang	China	323000
20	The First Affiliated Hospital of Xinjiang Medical University	Xinjiang		China
21	Xinxiang Central Hospital,	Xinxiang		China	453699

Sponsors and Collaborators

Shenyang Sunshine Pharmaceutical Co., LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shenyang Sunshine Pharmaceutical Co., LTD.

ClinicalTrials.gov Identifier:

NCT04089267

Other Study ID Numbers:

3sbio-TPO-403

First Posted:

Sep 13, 2019

Last Update Posted:

Sep 13, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thrombocytopenia

Purpura, Thrombocytopenic, Idiopathic

Study Results

No Results Posted as of Sep 13, 2019