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、CEPEG-IFN、Cepeginterferon Alfa 2 B

+ [2]

靶点

IFNAR

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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序列信息

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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35

项与 Cepeginterferon alfa-2b 相关的文献（医药）

2022-01-01·Urologic Oncology: Seminars and Original Investigations3区 · 医学

Intravesical sequential gemcitabine and docetaxel versus bacillus calmette-guerin (BCG) plus interferon in patients with recurrent non-muscle invasive bladder cancer following a single induction course of BCG

3区 · 医学

Article

作者: Brooks, Nathan ; Thomas, Lewis J ; Packiam, Vignesh T ; Kates, Max ; Kamat, Ashish M ; Nepple, Kenneth G ; O'Donnell, Michael A ; Vitale, Andrew ; Bivalacqua, Trinity J ; Wang, Jonathan ; DeWolf, William C ; Crump, Trafford ; Hyndman, M Eric ; Mott, Sarah L ; Steinberg, Ryan L ; Lamm, Donald L

INTRODUCTIONRepeat BCG induction remains an option for select non-muscle invasive bladder cancer (NMIBC) patients who fail initial therapy. Alternative salvage intravesical regimens such as Gemcitabine and Docetaxel (Gem/Doce) have been investigated. We aimed to compare the efficacy BCG plus interferon a-2b (BCG/IFN) and Gem/Doce in patients with recurrent NMIBC after a single prior BCG course.METHODSThe National Phase II BCG/IFN trial database and multi-institutional Gem/Doce database were queried for patients with recurrent NMIBC after one prior BCG induction course, excluding those with BCG unresponsive disease. Stabilized inverse probability treatment weighted survival curves were estimated using the Kaplan-Meier method and compared. Propensity scores were derived from a logistic regression model. The primary outcome was recurrence free survival (RFS); secondary outcomes were high-grade (HG) RFS and risk factors for treatment failure.RESULTSWe identified 197 BCG/IFN and 93 Gem/Doce patients who met study criteria. Patients receiving Gem/Doce were older and more likely to have HG disease, CIS, and persistent disease following induction BCG (all P < 0.01). After propensity score-based weighting, the adjusted 1- and 2-year RFS was 61% and 53% after BCG/IFN versus 68% and 46% after Gem/Doce (P = 0.95). Adjusted 1- and 2-year HG-RFS was 60% and 51% after BCG/IFN versus 63% and 42% after Gem/Doce (P = 0.68). Multivariable Cox regression revealed that Gem/Doce treatment was not associated with an increased risk of failure (HR = 0.97, P = 0.89) as compared to BCG/IFN.CONCLUSIONPatients with recurrent NMIBC after a single induction BCG failure and not deemed BCG unresponsive had similar oncologic outcomes with Gem/Doce and BCG/IFN in a post-hoc analysis. Additional prospective studies are needed.

2019-01-01·Gastroenterology and hepatology from bed to bench

Primary biliary cholangitis with contemporary presence of anti-mithocondrial and anti-rods and rings autoantibodies: literature first case.

作者: Roberto Assandri

Primary biliary cholangitis, previously known as primary biliary cirrhosis (PBC), is the most common autoimmune diseases of the liver (ALD). Patients with PBC may present with typical biliary pattern symptoms. Also the presence of anti-mitochondrial autoantibodies (AMAs) is the laboratory hallmark of PBC, which molecular target antigens are members of 2-oxoacid dehydrogenase complex of enzymes. In recent years, autoantibodies (Aab) targeting subcellular structures described as the rods and rings (R&R) pattern in HEp-2 ANA have been presented as a unique and particular case of Aab generation. These R&R structures are composed of inosine monophosphate dehydrogenase type 2 (IMPDH2), and their formation can be induced in vitro by several small-molecule inhibitors. Aab targeting these relatively unknown structures have been almost exclusively observed in hepatitis C virus (HCV) patients who have undergone treatment with pegylated interferon-a/ribavirin (IFN/RBV) therapy. Literature showed that anti-RR Aab have not been found in no treatment-naïve HCV patients or in patients from any other disease. Now we present and characterized a case patient with contemporary presence of AMAs and R&R Aab in PBC, without any laboratory evidence of HCV and/or other hepatic virus infection. For our knowledge, this is the first case described in the Literature. R&R Aab in patients without any clinical/laboratory signs or symptoms of Hepatitis virus and without pharmacological therapy open the window to the alternative scenario: the association of these Aab to ALD. Our work demonstrated that R&R Aab can be present in PBC case. The interesting idea suggested that R&R Aab may be present also in AMA-negative PBC and they can considered a new possible diagnostic tool in this specific clinical condition. Other study and cases are needed but the presence of R&R Aab linked with AMAs and PBC may be explained by alterations in immune regulation caused by autoimmunity in a particular genetic background.

2017-09-01·Urology Case Reports

Hemangioendothelioma of the Bladder: The Youngest Case Report in A Child

作者: Sibarani, Jupiter ; Vijay, Sawkar ; Armella, Laurina ; Tjahjodjati ; Siregar, Safendra ; Atik, Nur ; Rachmadi, Dedi

Hemangioendothelioma is a vascular tumor that commonly found in soft tissue, lungs, heart, liver, and bones, but it is very rare in bladder. We report a case of pediatric hemangioendothelioma of the bladder in a 2 years 7 months-old boy that treated with total excision of the bladder and bilateral ureterocutaneoustomy. This case is the second case in pediatric patients, and the youngest case that reported in a child. Our patient is doing well post operatively. But unfortunately interferon a-2b is not available in our hospital. At 3 months follow up, there was progressive progression of the tumor. Recurrent Abdominal mass was confirmed by Abdominal CT-Scan. The patient was died one week later. Interferon a-2b is might be an effective regimen on this tumor but further study is needed to confirm this statement.

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

10 条最早获批的记录,

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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

10 条进展最快的记录,

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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	临床前	俄罗斯	Biocad CJSC	2013-06-06
HIV感染	临床前	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)	遞築觸製糧遞願網廠醖(蓋壓鏇鏇鹹鬱鏇願壓鑰) = 夢壓積觸範艱選齋膚壓積顧製醖蓋艱製積壓繭 (窪鬱衊鏇餘餘鬱鹹襯繭, 夢鏇齋糧齋糧壓觸夢選 ~ 積遞憲範繭窪壓範襯淵) 更多	-	2015-08-18
				Algeron+Ribavirin (Algeron 2.0 μg/kg)	遞築觸製糧遞願網廠醖(蓋壓鏇鏇鹹鬱鏇願壓鑰) = 觸夢積艱遞膚獵積鏇淵積顧製醖蓋艱製積壓繭 (窪鬱衊鏇餘餘鬱鹹襯繭, 膚範衊糧襯選窪簾夢繭 ~ 鏇積構鏇壓淵蓋獵顧範) 更多
NCT02103439 (CTgov)	临床3期	HIV感染 \| 慢性丙型肝炎	140	Algeron (Algeron)	憲獵鹽齋觸鬱鹽鹹鏇餘(糧獵醖觸糧鏇憲憲觸膚) = 製獵餘範鬱憲窪蓋膚廠膚積餘蓋襯餘獵淵襯艱 (觸糧鹽鹹廠願糧獵鑰築, 構願積淵鹽鹹鏇顧獵簾 ~ 鏇範鹽膚網獵觸選艱積) 更多	-	2015-07-21
				PegIntron (PegIntron)	憲獵鹽齋觸鬱鹽鹹鏇餘(糧獵醖觸糧鏇憲憲觸膚) = 製餘鏇積廠獵觸艱築窪膚積餘蓋襯餘獵淵襯艱 (觸糧鹽鹹廠願糧獵鑰築, 範鹹壓夢蓋顧顧衊夢襯 ~ 窪選鏇艱鹹鹽繭鹽糧鹽) 更多