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

NCT04089267 | Completed Phase 4

• 1 other identifier: 3sbio-TPO-403
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 21

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).

Conditions

ITP

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (4)

experimental group 1

EXPERIMENTAL

rhTPO injection7500 U ;one time a day; 14 times of administration

Drug: TPO

experimental group 2

EXPERIMENTAL

rhTPO injection15000 U;one time a day;14 times of administration

Drug: TPO

experimental group 3

EXPERIMENTAL

rhTPO injection15000 U;1 time every other day, 7 times;

Drug: TPO

experimental group 4

EXPERIMENTAL

rhTPO injection30000 U；1 time every other day, 7 times;

Drug: TPO

Interventions

TPO DRUG

experimental group 1; experimental group 2; experimental group 3; experimental group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (21)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

Zhongshan Hospital Xiamen University

Xiamen, Fujian, 361004, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

Guangdong Second People's Hospital

Guangzhou, Guangdong, 510317, China

Location

Guangzhou Panyu Central Hospital

Guangzhou, Guangdong, 511400, China

Location

Harbin Institute of Hematology and Oncology

Haerbin, Heilongjiang, 150010, China

Location

Henan University of Science and Technology First Affiliated Hospital

Luoyang, Henan, 471003, China

Location

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, 450000, China

Location

Zhengzhou Central Hospital

Zhengzhou, Henan, 450007, China

Location

renmin Hospital of Wuhan University Hubei General Hospital

Wuhan, Hubei, 430060, China

Location

Loudi Central Hospital

Loudi, Hunan, 417118, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

First Affiliated Hospital Heilongjiang University of Chinese Medicine

Shenyang, Liaoning, 150040, China

Location

Xi An Central Hospital

Xi’an, Shanxi, 710499, China

Location

Chinese Academy of Medical Sciences Blood Disease Hospital

Tianjin, Tianjin Municipality, 300020, China

Location

Xinjiang Uygur Autonomous Region Chinese Medicine Hospital,

Ürümqi, Xinjiang, China

Location

Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310006, China

Location

Lishui City Center Hospital

Lishui, Zhejiang, 323000, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Xinjiang, China

Location

Xinxiang Central Hospital,

Xinxiang, 453699, China

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 13, 2019
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: August 1, 2019
• Last Updated: September 13, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (21)