ITP
Conditions
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).
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
Interventions
DRUGTPO
Sponsors
Shenyang Sunshine Pharmaceutical Co., LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| AE | up to 28days | — |
| Incidence of anti-rhTPO antibodies | up to 28days | — |
| The change in Platelet count from baseline on day 7 and day28 after the first dose | for day7and day28 | — |
| AUCss | up to 28days | — |
| Cav | up to 28days | average Blood concentration at steady state Blood concentration at steady state Blood concentration at steady state |
| the total effective rate of treatment in ITP patients on day 7 and day 28 | for day7and day28 | — |
Countries
China
Outcome results
None listed