Cepeginterferon alfa-2b(Cepeginterferon alfa-2b) - 药物靶点：IFNAR_在研适应症：丙型肝炎_专利_临床

概要

基本信息

药物类型

干扰素

别名

Algeron、Cepeginterferon Alfa 2 B、Cepeginterferon alfa 2b

+ [2]

靶点

IFNAR

作用方式

激动剂、刺激剂、诱导剂

作用机制

IFNAR激动剂(干扰素α/β受体复合体激动剂)、免疫刺激剂、先天性抗病毒免疫应答诱导剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

最高研发阶段批准上市

首次获批日期

俄罗斯 (2013-12-01),

丙型肝炎

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 26333714

来源: *****

关联

3

项与 Cepeginterferon alfa-2b 相关的临床试验

NCT01889433

/ Completed临床3期

An Open-label Randomized Multicenter Phase III Clinical Study Comparing Safety and Efficacy of Algeron (Cepeginterferon Alfa-2b) and Ribavirin With Pegasys (Peginterferon Alfa-2a) and Ribavirin for Treatment of Patients With Chronic Hepatitis C

The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to Pegasys in combination with ribavirin in the treatment of chronic hepatitis C.

开始日期2013-07-10

申办/合作机构

Biocad CJSC

NCT02103439

/ Completed临床3期

Multicenter Open-label Randomized, Comparative Clinical Study to Evaluate Efficacy and Safety of Algeron (Cepeginterferon Alfa-2b, CJSC "BIOCAD", Russia) With Ribavirin Compared to PegIntron (Peginterferon Alfa-2b, Schering-Plough Labo N.V., Belgium) With Ribavirin in Treatment of Chronic Hepatitis C in Human Immunodeficiency Virus-1 Infected Patients

The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to PegIntron in combination with ribavirin in treatment of chronic hepatitis C in Human Immunodeficiency Virus-1 infected patients

开始日期2013-06-06

申办/合作机构

Biocad CJSC

NCT01740089

/ Completed临床2/3期

Multicenter Open-label Randomized Prospective Clinical Study of Efficacy and Safety of Algeron (Cepeginterferon Alfa-2b) in Comparison With PegIntron (Peginterferon Alfa-2b) in the Combined Treatment of Chronic Hepatitis C

The purpose of the study is to demonstrate the noninferiority of Algeron 1.5 and 2.0 μg/kg/week in combination with ribavirin compared to PegIntron in combination with ribavirin in the treatment of chronic hepatitis C, and to determine therapeutic dose of Algeron.

开始日期2011-11-01

申办/合作机构

Biocad CJSC

100 项与 Cepeginterferon alfa-2b 相关的临床结果

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100 项与 Cepeginterferon alfa-2b 相关的转化医学

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100 项与 Cepeginterferon alfa-2b 相关的专利（医药）

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2

项与 Cepeginterferon alfa-2b 相关的文献（医药）

Terapevticheskii arkhiv4区 · 医学

Possibilities of using cepeginterferon alpha-2b in double (cepeginterferon alfa-2b and ribavirin) and triple (simeprevir, cepeginterferon alpha-2b, and ribavirin) antiviral therapy regimens for chronic hepatitis C. A review of clinical trials and experience of everyday clinical practice

4区 · 医学

ReviewOA

作者: Morozova, M A ; Maevskaya, M V ; Linkova, Yu N ; Klimova, E A ; Shuldyakov, А A ; Znoyko, O O

Since the incidence of chronic hepatitis C (CHC) increases steadily, the priority of national health care is to provide antiviral therapy (AVT) for the maximum number of patients infected with hepatitis C virus (HCV). The regimens including pegylated interferons (PEG-IFN) are still in demand in the Russian Federation. A number of clinical trials have been conducted to evaluate the efficacy and safety of cepeginterferon alpha-2b (cePEG-IFN alpha-2b), an original PEG-IFN-α developed in the Russian Federation. Their results have shown that cePEG-IFN alpha-2b in the two-component AVT regimen has at least no less clinical efficacy than PEG-IFN alpha-2b and PEG-INF alpha-2a in HCV monoinfected and HCV/HIV co-infected patients. The pooled analysis of data has indicated that the use of cePEG-IFN alpha-b in combination with ribavirin allows an average of 80% of the patients with HCV genotypes 2 and 3 and 62% of those with HCV genotype 1 to achieve a sustained virological response (SVR). In clinical practice when the two-component AVT regimen (cePEG-IFN alpha-b and ribavirin) was used in patients with early-stage CHC and mild fibrosis, SVR was recorded in 90.7% of the patients with HCV genotype 2/3 and in 75% of those with HCV genotype 1. The experience in using cePEG-IFN alpha-2b as a component of the three-component AVT regimen (simeprevir, cePEG IFN alfa-2b, and ribavirin) has been published. The observational program manly covered young patients with mild or moderate fibrosis. SVR was observed in 94% of the patients. Another paper describes the experience with the triple AVT therapy (simeprevir, cePEG-IFN alfa-2b, and ribavirin) in 22 patients, the majority of whom had advanced fibrosis. SVR was recorded in 71.4% of those who had completed treatment. Thus, an individual approach and assessment of predictive response factors to two- or three-component AVT regimens including cePEG-IFN alpha 2b can achieve successful treatment outcomes in most patients with CHC, which is, in some cases, more economically sound than interferon-free regimens used as first-line therapy.

Terapevticheskii arkhiv4区 · 医学

Cepeginterferon alfa-2b in the treatment of chronic myeloproliferative diseases

4区 · 医学

ArticleOA

作者: Subortseva, I N ; Melikyan, A L ; Pustovaya, E I ; Egorova, E K ; Savchenko, V G ; Zaritskey, A Yu ; Koloshejnova, T I ; Kovrigina, A M ; Abdullaev, A O ; Sudarikov, A B ; Siordiya, N T ; Lomaia, E G ; Gilyazitdinova, E A

Purpose of the study. A comparative evaluation of the effectiveness of different therapeutic strategies in patients with polycythemia vera (PV) and essential thrombocythemia (ET). Materials and methods. Patients with PV or ET, diagnosed according to the criteria WHO 2016 were included in the study. The primary endpoint - 6 months of therapy (clinical-hematological and molecular responses). The secondary endpoint - 12 months of therapy (clinico-hematologic, molecular, histological responses). Sixty three patients were included in the analysis: the first group consisted of 33 patients who received the therapy with ce-pegiterferone alpha-2b (ce-pegalpha-INF-α-2b), 10 of them received previous treatment; the second group - 23 patients btained hydroxycarbamide; the third group - 7 patients were treated with recombinant interferon alpha therapy (rINFα). In comparison groups, differences in age were revealed: patients receiving hydroxycarbamide therapy were older. Phlebotomy occurred in 36% of patients in the first group, 9% in the second group, and 14% in the third group. Results. By the 6th month of therapy, 43% of the patients receiving the ce-pegalpha-INF-α-2b had complete clinical-hematologic response, 36% had partial clinical-hematologic remission and stabilization of the disease was established in 21% cases. No disease progression occured. By the 12th month of therapy, statistically significant differences in terms of efficacy between the different therapeutic groups (p = 0.2462, Fisher's exact test). In all three groups, the allelic load of JAK2V617F decreased: from 50 to 19%, from 22.3 to 15.8%, from 50 to 7.19%, respectively. The lower the allele load positively correlated with better response to therapy, which was observed in all analyzed groups. Hematologic adverse events (AEs) were more frequently observed in patients receiving ce-pegalpha-INF-α-2b therapy. Local reactions developed on 3-7 days of therapy as a hyperemic macula at the injection site. Both these reactions and hair loss did not influence on patient’s condition. In the second group (patients with hydroxycarbamide therapy) there were changes in the skin and mucous membranes: dry skin, stomatitis, and in older patients new keratomas appeared. The flu-like syndrome was the most common adverse event associated with the therapy of ce-pegalpha-INF-α-2b, which fully relived during the first month of therapy. There was only one case with the flu-like syndrome we observed at the 11th month of therapy. As a rule, the biochemical blood test changes did not influence on patient’s condition, were mostly associated with dietary violations, had a tendency to self-resolution and did not require medical interventions. Serious AEs were reported in one case - pulmonary embolism in a patient treated with rINFα. The reasons for the therapy discontinue in group 1: toxic hepatitis, intolerance, by the request of the patient, inadequate efficacy of therapy; in group 2: skin toxicity, in group 3: thromboses. The conclusion. Treatment of ce-pegalpha-INF-α-2b in patients with PV and ET is highly effective - the most patients pbtained clinical and hematological responses. There were no statistically significant differences in these parameters in comparison with hydroxycarbamide and rINFα. The use of the ce-pegalpha-INF-α-2b had an acceptable safety profile. The estimated therapeutic dose should be calculated according to body weight. To reduce the frequency of hematologic AE, titration of the drug dose is required.

100 项与 Cepeginterferon alfa-2b 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L03AB14	DB12814

研发状态

批准上市

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适应症	国家/地区	公司	日期
丙型肝炎	俄罗斯	Biocad Medical, Inc.	2013-12-01

未上市

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适应症	最高研发状态	国家/地区	公司	日期
慢性丙型肝炎	临床2期	俄罗斯	Biocad CJSC	2013-06-06
HIV感染	临床2期	俄罗斯	Biocad CJSC	2013-06-06

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01740089 (CTgov)	临床2/3期	慢性丙型肝炎	150	Algeron+Ribavirin (Algeron 1.5 μg/kg)	積鏇廠憲顧艱顧築製網(餘遞襯鑰廠繭憲夢憲繭) = 築餘鏇積膚繭鏇壓範願艱淵醖築憲糧鬱窪製願 (鏇襯繭願觸衊蓋糧憲遞, 鑰蓋繭鬱鑰鏇鹽網醖簾 ~ 網構製壓鑰窪廠憲範壓) 更多	-	2015-08-18
				Algeron+Ribavirin (Algeron 2.0 μg/kg)	積鏇廠憲顧艱顧築製網(餘遞襯鑰廠繭憲夢憲繭) = 糧簾蓋餘顧觸積鹽鹹淵艱淵醖築憲糧鬱窪製願 (鏇襯繭願觸衊蓋糧憲遞, 範鏇壓範衊繭願蓋積積 ~ 顧襯壓構鏇膚廠淵願觸) 更多
NCT02103439 (CTgov)	临床3期	HIV感染 \| 慢性丙型肝炎	140	Algeron (Algeron)	築簾艱網衊鹹鏇顧顧齋(選淵廠窪繭遞蓋壓製廠) = 蓋願醖觸艱範膚餘齋鏇廠觸顧糧糧觸顧醖鹽憲 (選鹹積淵獵壓簾淵製網, 觸壓遞鬱簾積網鹽壓齋 ~ 襯壓夢積鏇構繭製範鏇) 更多	-	2015-07-21
				PegIntron (PegIntron)	築簾艱網衊鹹鏇顧顧齋(選淵廠窪繭遞蓋壓製廠) = 憲憲夢淵顧廠鹽衊製醖廠觸顧糧糧觸顧醖鹽憲 (選鹹積淵獵壓簾淵製網, 築鏇願觸襯齋憲網鬱鹽 ~ 淵製繭鑰夢觸壓範網簾) 更多