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

• Status: Completed
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

Criteria

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.