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

Shenyang Sunshine Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: ITP

Treatments: Drug: TPO

Study type: Interventional

Funder types: Industry

Identifiers

NCT04089267

3sbio-TPO-403

Details and patient eligibility

About

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).

Full 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

Enrollment: 288 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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288 participants in 4 patient groups

experimental group 1

Experimental group

Description:

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

Treatment:

Drug: TPO

experimental group 2

Experimental group

Description:

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

Treatment:

Drug: TPO

experimental group 3

Experimental group

Description:

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

Treatment:

Drug: TPO

experimental group 4

Experimental group

Description:

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

Treatment:

Drug: TPO