[Translation] An open, single-arm, multicenter clinical trial to evaluate the efficacy and safety of intravenous human immunoglobulin (10%) in the treatment of primary immune thrombocytopenia

主要目的：评价新型静注人免疫球蛋白（10%）治疗原发免疫性血小板减少症（ITP）的疗效，通过分析首次用药治疗后7天内受试者血小板计数≥30×109/L并且提高到基线2倍以上的受试者比例，评价贵州泰邦生物制品有限公司生产的静注人免疫球蛋白（10%）的疗效。次要目的： 1)通过其它次要疗效指标，观察和评价疗效差异； 2)观察和评价安全性。

[Translation]

Primary purpose: To evaluate the efficacy of new intravenous human immunoglobulin (10%) in the treatment of primary immune thrombocytopenia (ITP), and to evaluate the efficacy of intravenous human immunoglobulin (10%) produced by Guizhou Taibang Biological Products Co., Ltd. by analyzing the proportion of subjects with platelet count ≥30×109/L and increased to more than 2 times the baseline within 7 days after the first medication. Secondary objectives: 1) Observe and evaluate the difference in efficacy through other secondary efficacy indicators; 2) Observe and evaluate safety.

Start Date10 Jul 2020

Sponsor / Collaborator

Guizhou Taibang Biological Products Co., Ltd.

100 Clinical Results associated with Human immunoglobulin(Guizhou Taibang Biological Products Co., Ltd.)

100 Translational Medicine associated with Human immunoglobulin(Guizhou Taibang Biological Products Co., Ltd.)

100 Patents (Medical) associated with Human immunoglobulin(Guizhou Taibang Biological Products Co., Ltd.)

Literatures (Medical) associated with Human immunoglobulin(Guizhou Taibang Biological Products Co., Ltd.)

01 Jul 2023·Journal of the American Veterinary Medical Association

Human intravenous immunoglobulin use for hematological immune-mediated disease in dogs

Article

Author: Greer, Ristan M. ; Kane, Briannan-Kym

AbstractOBJECTIVETo report on survival rates and risk factors in dogs with immune-mediated hemolytic anemia (IMHA) and immune-mediated thrombocytopenia (ITP) treated with human IV immunoglobulin (hIVIG; Privigen). We hypothesized that hIVIG could be used as a salvage treatment to improve survival and reduce the requirement for ongoing blood transfusion therapy in IMHA and ITP patients.ANIMALS52 client-owned dogs with IMHA or ITP were included, comprising 31 females (28 spayed and 3 entire) and 21 males (19 castrated and 2 entire). Miniature Schnauzers were the most common breed (5), with a further 24 different breeds identified.PROCEDURESA retrospective cohort study was conducted between January 2006 and January 2022 that assessed the survival rates, risk factors, and need for ongoing transfusion in dogs with IMHA and ITP treated with hIVIG compared with those not receiving hIVIG.RESULTSOf 36 dogs that did not receive hIVIG, 29 (80%) survived and 7 (24%) died, and of 16 dogs administered hIVIG, 11 (69%) survived and 5 (31%) died (P = .56). No effect of PCV at admission or age on the risk of death was detected (OR, 1.00; 95% CI, 0.94 to 1.08; P = .89; and OR, 1.10; 95% CI, 0.85 to 1.47; P = .47, respectively).CLINICAL RELEVANCEThis was the largest study to date of dogs with hematological immune-mediated disease treated with hIVIG. There was no difference in survival rates for dogs that received hIVIG versus those treated with standard immunosuppression. The benefit of hIVIG as a salvage treatment appears limited.

29 Jun 2023·Journal of medical case reports

Anti-N-methyl-D-aspartate receptor encephalitis and positive human herpesvirus-7 deoxyribonucleic acid in cerebrospinal fluid: a case report.

Article

Author: Grikinienė, Jurgita ; Samaitienė-Aleknienė, Rūta ; Praninskienė, Rūta ; Simonavičiutė, Viktorija

BACKGROUNDAnti-N-methyl-D-aspartate receptor encephalitis is a neuroautoimmune syndrome typically presenting with seizures, psychiatric symptoms, and autonomic dysfunction. Human herpesvirus-7 is often found with human herpesvirus-6 and infects leukocytes such as T-cells, monocytes-macrophages, epithelial cells, and central nervous system cells. The pathogenicity of human herpesvirus-7 is unclear. Cases of anti-N-methyl-D-aspartate receptor encephalitis with human herpesvirus-7 present in cerebrospinal fluid have been documented, but the clinical significance of this finding remains unclear.CASE PRESENTATIONAn 11-year-old Caucasian boy was admitted to hospital after a generalized tonic-clonic seizure. Generalized tonic seizures repeated three more times during the day of hospitalization. Blood tests showed minor ongoing inflammation, while brain computed tomography yielded normal results. Brain magnetic resonance imaging showed hyperintense focal alterations in both temporal lobes, hippocampi, and at the base of the right frontal lobe. Positive anti-N-methyl-D-aspartate receptor antibodies were found in both serum and cerebrospinal fluid. Positive novel coronavirus 2 (severe acute respiratory syndrome coronavirus 2) immunoglobulin G antibodies were found in serum. Polymerase chain reaction test for severe acute respiratory syndrome coronavirus 2 was negative. Furthermore, positive human herpesvirus-7 deoxyribonucleic acid was found in cerebrospinal fluid. The patient was treated with acyclovir, human immunoglobulin, and methylprednisolone. The seizures did not repeat, and no psychiatric symptoms were present. The patient made a full recovery.CONCLUSIONSWe present a pediatric case of anti-N-methyl-D-aspartate receptor encephalitis with atypical clinical presentation. The role of human herpesvirus-7 in neurological disorders remains unclear in immunocompetent patients.

28 Mar 2023·Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences

Efficacy and safety of avatrombopag for thrombocytopenia following allogeneic hematopoietic stem cell transplantation: A real-world data evaluation on 14 cases.

Article

Author: Li, Shujun ; Liu, Yi ; Liu, Enyi ; Chen, Yan ; Xu, Yajing ; Xin, Hongya ; Fang, Peng

OBJECTIVESThrombocytopenia following allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a common and serious complication that leads to an increased risk of bleeding and poor prognosis. Traditional strategies consist of platelet transfusion, glucocorticoid therapy, intravenous human immunoglobulin, recombinant human thrombopoietin injection, and CD34⁺-selected hematopoietic stem cell transplantation, but the effects of these treatments are not satisfactory and the treatment continues to be challenged. This study aims to determine the treating efficacy of avatrombopag, a novel thrombopoietin receptor agonist, on thrombocytopenia after allo-HSCT, and to increase the evidence-based medical evidence for the clinical use of this drug.METHODSFourteen patients with thrombocytopenia after allo-HSCT underwent avatrom-bopag treatment from September 2020 to September 2021 were retrospectively studied. Of these patients, 8 patients had delayed platelet engraftment (DPE) and 6 cases had secondary failure of platelet recovery (SFPR). The efficacy and safety of the treatment and the survival of the patients were assessed.RESULTSThe median treatment time of avatrombopag was 34 days, and no patients stopped treatment due to adverse reactions or drug intolerance. Compared with the treatment before, the levels of platelet count, megakaryocytes, and hemoglobin in patients were significantly increased (P=0.000 1, P=0.001 0, and P=0.001 7, respectively). The optimal platelet count of 13 patients reached the complete response standard after drug withdrawal. The median follow-up time of 14 patients was 371 days, and the 2-year overall survival rate was 78.6%.CONCLUSIONSAvatrombopag is effective on increasing platelet counts in patients with thrombocytopenia after allo-HSCT, with a good safety profile. It is a suitable therapeutic option for thrombocytopenia after allo-HSCT.

100 Deals associated with Human immunoglobulin(Guizhou Taibang Biological Products Co., Ltd.)

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Indication	Country/Location	Organization	Date
Hepatitis	CN	Guizhou Taibang Biological Products Co., Ltd.	23 Jun 2020
Measles	CN	Guizhou Taibang Biological Products Co., Ltd.	23 Jun 2020

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Indication	Highest Phase	Country/Location	Organization	Date
Purpura, Thrombocytopenic, Idiopathic	Discovery	CN	Guizhou Taibang Biological Products Co., Ltd.	10 Jul 2020

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