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

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)

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).

Study Overview

• Status: Completed
• Conditions: ITP
• Intervention / Treatment: Drug: TPO

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 Type: Interventional
• Enrollment (Actual): 288
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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 Measures

Outcome Measure	Measure Description	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	average Blood concentration at steady state Blood concentration at steady state Blood concentration at steady state	up to 28days
AUCss		up to 28days

Collaborators and Investigators

• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): August 1, 2019

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (ACTUAL): September 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2019
• Last Update Submitted That Met QC Criteria: September 12, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Blood Coagulation Disorders; Skin Manifestations; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura, Thrombocytopenic; Purpura; Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia
• Other Study ID Numbers: 3sbio-TPO-403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No