[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial evaluating interferon α-2 injection in the treatment of chronic HBV infection in the low-replication phase

评价培集成干扰素α-2注射液治疗低复制期慢性HBV感染者的疗效及安全性，为药物注册申请和临床使用提供充分依据。

[Translation]

To evaluate the efficacy and safety of peginterferon α-2 injection in the treatment of chronic HBV infection in the low replication phase, and to provide sufficient basis for drug registration application and clinical use.

Start Date21 Dec 2021

Sponsor / Collaborator

Chongqing Fujin Biological Medicine Co Ltd

CTR20213449 / CompletedPhase 2

多中心、随机、开放、平行、阳性对照评价聚乙二醇化重组集成干扰素变异体注射液治疗慢性乙型肝炎疗效及安全性Ⅱ期临床试验

[Translation] A multicenter, randomized, open, parallel, positive-controlled phase II clinical trial to evaluate the efficacy and safety of pegylated recombinant interferon variant injection in the treatment of chronic hepatitis B

评价聚乙二醇化重组集成干扰素变异体注射液治疗慢性乙型肝炎的疗效及安全性。探索试验药多个剂量组间的量效关系及各试验剂量组的疗效和安全性，综合评估药物的安全使用范围和最佳临床推荐剂量，为验证性试验给药剂量的确定提供依据。

[Translation]

To evaluate the efficacy and safety of pegylated recombinant integrated interferon variant injection in the treatment of chronic hepatitis B. To explore the dose-effect relationship between multiple dose groups of the test drug and the efficacy and safety of each test dose group, comprehensively evaluate the safe use range of the drug and the best clinical recommended dose, and provide a basis for determining the dose of the confirmatory trial.

Start Date24 Sep 2014

Sponsor / Collaborator

Chongqing Fujin Biological Medicine Co Ltd

CTR20130081 / RecruitingPhase 3

多中心、随机、开放、平行、阳性对照评价PEG-IFN-SA治疗慢性丙型肝炎疗效及安全性Ⅲ期临床试验

[Translation] A multicenter, randomized, open, parallel, positive-controlled phase III clinical trial to evaluate the efficacy and safety of PEG-IFN-SA in the treatment of chronic hepatitis C

验证聚乙二醇化重组集成干扰素变异体注射液治疗不同基因型别慢性丙型肝炎的疗效及安全性，为药物注册申请和临床使用提供充分依据。

[Translation]

To verify the efficacy and safety of pegylated recombinant integrated interferon variant injection in the treatment of chronic hepatitis C with different genotypes, and provide sufficient basis for drug registration application and clinical use.

Start Date12 Aug 2013

Sponsor / Collaborator

Chongqing Fujin Biological Medicine Co Ltd

100 Clinical Results associated with Pegylated Recombinant Consensus Interferon Variant(Chongqing Fujin Biological Medicine Co Ltd)

100 Translational Medicine associated with Pegylated Recombinant Consensus Interferon Variant(Chongqing Fujin Biological Medicine Co Ltd)

100 Patents (Medical) associated with Pegylated Recombinant Consensus Interferon Variant(Chongqing Fujin Biological Medicine Co Ltd)

Literatures (Medical) associated with Pegylated Recombinant Consensus Interferon Variant(Chongqing Fujin Biological Medicine Co Ltd)

01 Mar 2016·Int. Journal of Clinical Pharmacology and TherapeuticsQ4 · MEDICINE

Association of immune response parameters with virological response in hepatitis C virus patients treated with pegylated consensus interferon

Q4 · MEDICINE

Article

Author: Li, Xiaojiao ; Zhang, Hong ; Liu, Chengjiao ; Chen, Hong ; Ding, Yanhua ; Li, Qingmei ; Niu, Junqi

BACKGROUNDA new, potent, long lasting recombinant interferon variant (pegylated consensus interferon, PEGCIFN) was expressed by Escherichia coli. The aim of this study was to test safety and antiviral activity of the new type of interferon in adults with hepatitis C virus (HCV) infection and to determine the relationship between immune response markers and virological response.METHOD40 naive HCV patients (1 : 1 : 1 : 1) were injected subcutaneously with PEG-CIFN 1.0, 1.5, 2.0 μg/kg and peginterferon-α 180 μg once per week for 12 weeks. Serum HCV RNA, cytokines, chemokines levels were tested, and clinical data were collected at this course.RESULTSPEG-CIFN is safety/tolerability. The serum HCV RNA levels were markedly decreased after therapy. 20% (2/10), 70% (7/10), 70% (7/10), and 60% (6/10) exhibited early virologic responses (EVR (+)) during PEGCIFN 1.0, 1.5, and 2.0 μg/kg treatment and peginterferon-α 180 μg treatment, respectively. Interleukin-4, interferon induced protein 10 (IP-10), and macrophage inflammatory protein 1β (MIP-1β) levels were lower, and granulocyte colony-stimulating factor levels were higher in EVR (+) than in the group not having an EVR (EVR (-)) (p < 0.05) after PEG-CIFN treatment. IP-10 and MIP-1β levels were associated with HCV RNA values, alanine aminotransferase, and aspartate aminotransferase levels after PEG-CIFN treatment.CONCLUSIONPEGCIFN was well tolerated and effective at inhibiting HCV RNA, which is associated with changes in markers of immune response. PEG-CIFN 1.5 μg/kg has been selected for further hepatitis C clinical development.

01 Apr 2015·British Journal of Clinical PharmacologyQ2 · MEDICINE

A pharmacokinetic and pharmacodynamic comparison of a novel pegylated recombinant consensus interferon‐α variant with peginterferon‐α‐2a in healthy subjects

Q2 · MEDICINE

Article

Author: Wang, Ying ; Gou, Zhong Ping ; Xu, Nan ; Cai, Yong Ming ; Zheng, Li ; Li, Mao Ping ; Luo, Hua

AimsThe aims of the study were to assess the pharmacokinetics, pharmacodynamics, safety and tolerability of a novel, pegylated recombinant human consensus interferon‐α variant (PEG‐IFN‐SA) in healthy volunteers. A pharmacokinetic and pharmacodynamic comparison of PEG‐IFN‐SA and peginterferon‐α‐2a in healthy subjects was evaluated.MethodsA randomized, dose‐escalating, single administration dose phase I clinical study was conducted. Thirty healthy subjects received PEG‐IFN‐SA as a single dose of 0.5–2.0 μg kg−1 by subcutaneous (s.c.) injection in four parallel groups. Eight subjects received peginterferon‐α‐2a as a single dose of 180 μg s.c.ResultsThe incidence rates of adverse events for PEG‐IFN‐SA and peginterferon‐α‐2a were 29 of 30 and 7 of 8, respectively. The adverse events for PEG‐IFN‐SA were mild to moderate and similar to those of peginterferon‐α‐2a. Within 168 h after injection, the mean values of maximal concentration and area under the plasma concentration–time curve from time of dosing to 168 h [AUC(0–168h)] for 2′,5′‐oligoadenylate, neopterin and β2‐microglobulin for PEG‐IFN‐SA at 1.5 μg kg−1 s.c. were similar to or higher than those for peginterferon‐α‐2a at a dose of 180 μg s.c. After s.c. injection of PEG‐IFN‐SA at 1.5 μg kg−1, the mean geometric mean values of plasma half‐life, time to maximal concentration, maximal concentration and AUC(0–168h) were 55.3 h, 26.9 h, 0.53 μg l−1 and 44.0 μg l−1 h, respectively.ConclusionsThe tolerance, pharmacokinetic and pharmacodynamic characteristics of PEG‐IFN‐SA support its administration by s.c. injection as a single dose of 1.5 μg kg−1 or at 2.0 μg kg−1 per week.

01 Jan 2012·Regulatory Peptides

Pharmacokinetics, tissue distribution, excretion, and antiviral activity of pegylated recombinant human consensus interferon-α variant in monkeys, rats and guinea pigs

Article

Author: Hua Luo ; Wenjin Shen ; Changxiao Liu ; Yongming Cai ; Duanyun Si ; Yong Zeng ; Peng Fu ; Jun Zhang ; Kai Fan ; Ming Li ; Zongpeng Zhang

The study aims to characterize the pharmacokinetic, tissue distribution, excretion, and antiviral activity properties of a novel pegylated recombinant human consensus interferon-α variant (PEG-IFN-SA) following a single subcutaneous administration to monkeys, rats and guinea pigs. Studies included: (1) pharmacokinetic properties of PEG-IFN-SA and comparison with those of non-pegylated IFN-SA in rhesus monkeys and rats; (2) tissue distribution and urinary, fecal, and biliary excretion patterns of (125)I-PEG-IFN-SA in guinea pigs; and (3) antiviral activity assessment of PEG-IFN-SA in cynomolgus monkeys. The pegylated protein exhibited improved pharmacokinetic properties compared to IFN-SA in both monkeys and rats, with a 12-fold and 15-fold increase in elimination half-life, and a 100-fold and 10-fold decrease in serum clearance, as well as a 2.5-fold and 10-fold increase in the time to reach peak serum concentration, respectively. (125)I-PEG-IFN-SA was found to be distributed to most of the tissues examined and has character of targeting special distribution, and urinary appeared to be a major route for the excretion of PEG-IFN-SA in guinea pigs. Serum sample analysis from PEG-IFN-SA-treated monkeys showed dose-dependent antiviral activity for one week. These findings demonstrate that pegylation of IFN-SA results in more desirable pharmacokinetic properties, enhanced drug exposure and sustained-efficacy of in vivo antiviral action.

100 Deals associated with Pegylated Recombinant Consensus Interferon Variant(Chongqing Fujin Biological Medicine Co Ltd)

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Indication	Country/Location	Organization	Date
Hepatitis C, Chronic	CN	Chongqing Fujin Biological Medicine Co Ltd	06 Jul 2018

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10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis B, Chronic	Phase 3	CN	Chongqing Fujin Biological Medicine Co Ltd	21 Dec 2021

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