[Translation] An open, single-arm, multicenter clinical trial to evaluate the efficacy and safety of intravenous human immunoglobulin (pH4) in the treatment of primary immune thrombocytopenia (ITP)

主要目的：通过提升血小板的有效率，评价静注人免疫球蛋白（pH4）治疗原发免疫性血小板减少症（ITP）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；（2）观察和评价安全性，包括临床症状体征观察和实验室指标，AE（和SAE）的发生率和严重程度。

[Translation]

Primary objective: To evaluate the efficacy of intravenous human immunoglobulin (pH4) in the treatment of primary immune thrombocytopenia (ITP) by improving the effective rate of platelets. Secondary objectives: (1) To observe and evaluate the efficacy through other secondary efficacy indicators; (2) To observe and evaluate safety, including clinical symptoms and signs, laboratory indicators, and the incidence and severity of AEs (and SAEs).

Start Date17 May 2023

Sponsor / Collaborator

Guangdong Danxia Biological Pharmaceutical Co. Ltd.

CTR20220721 / CompletedPhase 3

评价静注人免疫球蛋白（10%）在成年及青少年（≥12岁）中治疗原发免疫性血小板减少症有效性和安全性的开放、单臂、多中心Ⅲ期临床研究

[Translation] An open, single-arm, multicenter phase III clinical study to evaluate the efficacy and safety of intravenous human immunoglobulin (10%) in the treatment of primary immune thrombocytopenia in adults and adolescents (≥12 years old)

主要目的：评价静注人免疫球蛋白（10%）在成年及青少年（≥12岁）中治疗原发免疫性血小板减少症（ITP）的疗效，通过分析首次输注治疗后7天内受试者血小板计数≥30×109/L且提高到基线2倍以上的受试者比例，评价博雅生物制药集团股份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；2）观察和评价安全性。

[Translation]

Primary purpose: To evaluate the efficacy of intravenous human immunoglobulin (10%) in the treatment of primary immune thrombocytopenia (ITP) in adults and adolescents (≥12 years old), and to evaluate the efficacy of intravenous human immunoglobulin (10%) produced by Boya Biopharmaceutical Group Co., Ltd. by analyzing the proportion of subjects with platelet counts ≥30×109/L and increased to more than 2 times the baseline within 7 days after the first infusion. Secondary purpose: 1) Observe and evaluate the efficacy through other secondary efficacy indicators; 2) Observe and evaluate safety.

Start Date21 Jun 2022

Sponsor / Collaborator

China Resources Boya Bio-pharmaceutical Group Co., Ltd.

100 Clinical Results associated with Human immunoglobulin(pH4)(Boya Bio-pharmaceutical Group Co., Ltd.)

100 Translational Medicine associated with Human immunoglobulin(pH4)(Boya Bio-pharmaceutical Group Co., Ltd.)

100 Patents (Medical) associated with Human immunoglobulin(pH4)(Boya Bio-pharmaceutical Group Co., Ltd.)

Literatures (Medical) associated with Human immunoglobulin(pH4)(Boya Bio-pharmaceutical Group Co., Ltd.)

01 Dec 1998·Transfusion Science

Effect of Intravenous Immunoglobulin Therapy on Plasma Complement

Article

Author: Wegmüller, E

The effect of the intravenous immunoglobulin preparation (Sandoglobulin) on the complement system and the formation of circulating immune complexes (CIC) was investigated in 10 patients with primary humoral immunodeficiency and in 12 normal volunteers. Infusion of 9 g of the pH4 treated preparation did not show relevant changes in total hemolytic complement activity, plasma levels of C4, C3, and factor B. C3dg fragments, however, increased markedly in some individuals in both groups immediately after infusion. CIC measured by 125 I-C1q binding were not detectable. Furthermore, the initially low C1q concentrations in immune-deficient patients correlated with the pre-infusion IgG levels (p < 0.05) and rose significantly 24 h after therapy (p < 0.001). In contrast, in vitro incubation of the immunoglobulin preparation with normal human serum did not reveal spontaneous anticomplementary activity nor did it lead to formation of immune aggregates. The results indicate that immunoglobulin infusions may moderately activate complement in vivo, as evidenced by increased C3dg fragments; in addition, partial C1q deficiency in hypogammoglobulinemia seems to be related to IgG concentration and can be corrected by immunoglobulin substitution.

01 Jul 1989·Vox SanguinisQ4 · MEDICINE

Transmission of Non‐A, Non‐B Hepatitis by pH4‐Treated Intravenous Immunoglobulin

Q4 · MEDICINE

Article

Author: P.E. Williams ; S.J. Urbaniak ; P.L. Yap ; J. Gillon ; G. Galea ; R.J. Crawford

Abstract. Four patients (2 with X‐linked, one with common variable hypogammaglobulinaemia, and 1 with ulcerative colitis) developed non‐A, non‐B hepatitis (NANBH) following administration of a specific batch of intravenous immunoglobulin (IV IgG) manufactured by the Scottish National Blood Transfusion Service using the pH4/mild pepsin method. Each patient had normal serum ALT levels over a preceding period of 12–67 months, with raised values developing within 4–18 weeks of first administration of the implicated batch. Two patients had very mild symptoms of hepatitis, the other 2 being asymptomatic. Over a follow‐up period of 8–12 months, ALT levels returned to normal in 3 patients, but biopsy‐proven chronic NANBH developed in the fourth. The level of NANBH virus in the starting plasma used to manufacture this batch may have exceeded the capacity of the process to inactivate the virus. The transmission of NANBH by one of approximately 110 batches administered demonstrates the importance of continued close surveillance of recipients of IV IgG, even if asymptomatic, by regular monitoring of liver function tests and recording of all batches received.

100 Deals associated with Human immunoglobulin(pH4)(Boya Bio-pharmaceutical Group Co., Ltd.)

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Immunoglobulin deficiency	CN	China Resources Boya Bio-pharmaceutical Group Co., Ltd.	01 Jan 1998
Immunoglobulin deficiency	CN	Guangdong Danxia Biological Pharmaceutical Co. Ltd.	01 Jan 1998

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Purpura, Thrombocytopenic, Idiopathic	Phase 3	CN	China Resources Boya Bio-pharmaceutical Group Co., Ltd.	21 Jun 2022

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Human immunoglobulin(pH4)(Boya Bio-pharmaceutical Group Co., Ltd.)

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