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

Study Overview
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Brief Summary
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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).

Detailed Description
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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

Official Title
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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)

Conditions
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ITP

Intervention / Treatment
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* Drug: TPO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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