Active clinical trials for "Purpura, Thrombocytopenic, Idiopathic"

This multicenter randomized, open-label study aime to compare the efficacy and safety of TPO-RAs combining anti-CD 20 monoclonal antibody with TPO-RAs in China pediatric ITP patients .This study will be conducted in persistent or chronic pediatric ITP patients who had not responded to or had relapsed after previous hormone treatment.

TE-ITP study: Compare the efficacy and safety of optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia patients.

Randomized, open-label, multicenter study to compare the efficacy and safety of combination of tacrolimus and danazol versus danazol for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP).

The study will involve patients with chronic immune thrombocytopenia. This disease is diagnosed in the presence of isolated thrombocytopenia (decrease in platelet count only), except for other reasons. The addition of "chronic" means that the disease lasts more than 12 months. Patients included in the study will receive Bioven, 10% solution for infusion according to the protocol for the use of IVIG in ITP - at a dose of 0.8-1.0 g / kg 1 time per day for 2 consecutive days, the course dose of 1.6-2.0 g / kg according to the "Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIG)", rev. 3, 28 June 2018. After administration of the investigational drug, patients will be under medical supervision for 28 days. The stay of patients in the study - at least 4 weeks.

Investigator-initiated, single-arm, open-label, single dose clinical study to evaluate the safety and preliminary efficacy of CNCT19 in treatment of patients with refractory systemic lupus erythematosus(SLE) presented with active lupus nephritis or active immune thrombocytopenia.

SLE associated immune thrombocytopenia (SLE-ITP) is one of the main clinical manifestations of SLE. Approximately 70% of SLE patients follow a relapsing-remitting course. Similarly, SLE-ITP often relapses during GCs tapering. At the same time, patients with SLE-ITP may suffer from thrombocytopenia and damage to vital organs when they relapse, seriously affecting their lives. Therefore, maintenance therapy after remission is an inevitable choice for SLE-ITP. The SLE guidelines recommend GCs and immunosuppressive agents(ISA) are first-line maintenance treatment in the treatment of SLE-ITP. GCs is indispensable in SLE treatment, but it is associated with a series of side effects, which are related to the dosage and duration of use. How to maintain remission with the most appropriate dose of GCs is a problem that needs to be considered in clinical practice. However, the existing guidelines lack detailed recommendations on the specific use of GCs in maintenance therapy for SLE-ITP, and there is also a lack of relevant clinical studies to guide. The GCs reduction regimen commonly used in maintenance therapy is a gradual reduction after 1 month of adequate GCs therapy, usually by 10% of the original dose every 2 weeks. However, the side effects of this reduction method are obvious, and whether the treatment can be maintained with less cumulative dose and maintenance duration of GCs is an urgent problem to be solved. Clinical observations show that in a small number of patients with relative contraindications to GCs, a more rapid taper can maintain an effective response. Currently, rapid dosing reduction is recommended in both Lupus nephritis(LN) and the ANCA-associated nephritis guidelines of ACR. However, SLE-ITP changes more rapidly than LN. Although similar maintenance responses have been observed in a few patients between rapid dosing reduction and conventional method, relevant clinical studies are lacking. It is necessary to explore the effectiveness of rapid GCs tapering method. Therefore, the investigators plan to conduct a single-center, prospective, randomized design, non-blind, non-inferiority controlled study on the optimization of GCs taper strategy for SLE-ITP maintenance therapy.In this study,sustained response rate and relapse rate within 3 months and 6 months were observed to judge the effectiveness of rapid GCs taper strategy, thus providing a basis for clinical GCs taper strategy.

It is a phase III extension study to assess safety and immunogenicity of long-term therapy with GNR-069 in patients with idiopathic thrombocytopenic purpura

This is a multisite, double-blind, randomized, placebo-controlled, and parallel study designed to evaluate the clinical efficacy and safety of Huaiqihuang granule for treatment to children with chronic primary immune thrombocytopenia (Qi Yin deficiency).

This is a 2 part (Part A and B) adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/μL on two counts no sooner than 7 days apart in the 15 days before treatment begins. The dose-finding portion of the study has been completed. Part B treatment dose is 400 mg twice daily.

The purpose of this study is to compare the ability of eltrombopag in combination with a short course of high-dose dexamethasone to induce sustained response off treatment in patients with newly-diagnosed ITP versus 1-3 cycles of dexamethasone monotherapy. The unmet clinical need and the potential for eltrombopag when added to steroids to improve the treatment outcome and the potential to induce sustained response off treatment serve as the basis for clinical investigation of eltrombopag in first-line ITP.