Observational Prospective Registry of the Efficacy, Safety, and Adherence to Therapy of Infergen® (Interferon Alfacon 1) in Patients Chronically Infected With Hepatitis C Virus

This observational prospective registry is designed to evaluate the safety, adherence, and efficacy of prescribed, patient-administered therapy with Infergen® (Interferon alfacon 1) and other prescribed therapies in patients chronically infected with HCV. The primary endpoint for efficacy will be the SVR rate at 24 weeks after therapy ends.

开始日期2009-08-01

申办/合作机构

Kadmon Corp. LLC

NCT00456248 / Terminated临床4期

Phase 4 Study Using Infergen and Ribavirin in Patients With Chronic Hepatitis C Virus Who Achieved Partial Response to Peginterferon-alfa and Ribavirin Therapy

This is a 60-to-72 week multicenter study to evaluate Infergen and Ribavirin in patients with Chronic Hepatitis C Virus after partial response to treatment using peginterferon-alfa and Ribavirin therapy. The study will be conducted at approximately 50 sites across the United States.

开始日期2007-02-01

申办/合作机构

Kadmon Corp. LLC

NCT00211692 / Completed临床3期IIT

Prospective Randomized Pilot Study of Daily Consensus Interferon (CIFN) and Ribavirin for 52 Wks vs Extended Duration 72 Wks Based on Virologic Response for the Initial Treatment of Difficult-to-treat Patients With Chronic HCV Genotype 1

Data have suggested that consensus interferon (CIFN) has greater antiviral activity in vitro compared with interferon alfa-2a or alfa-2b. Several clinical studies also suggest that CIFN has greater antiviral activity in patients with genotype 1 hepatitis C infection, particularly if given as a daily injection. These data indicate that the use of a regimen of daily CIFN and ribavirin will lead to greater virologic response rates compared with pegylated interferon alfa-2b and ribavirin in patients with genotype 1 infection, with comparable adverse events. Emerging data indicate that HCV genotype 1 patients with a delayed virologic response to initial therapy may benefit from an extended duration of therapy. Therefore, the goals of this pilot study are to determine the tolerability and efficacy of daily CIFN plus ribavirin when given for 52 weeks or an extended duration of therapy. The target population will consist of "difficult-to-treat" patients, defined as having the following characteristics: genotype 1, a North American patient population, predominantly male gender, and no specific exclusions for pre-existing psychiatric or substance abuse co-morbidities.

开始日期2005-07-01

申办/合作机构

Minneapolis VA Health Care System

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100 项与 INTERFERON ALFACON-1 相关的临床结果

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100 项与 INTERFERON ALFACON-1 相关的转化医学

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100 项与 INTERFERON ALFACON-1 相关的专利（医药）

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174

项与 INTERFERON ALFACON-1 相关的文献（医药）

2022-10-01·Drug research

Pathway Analysis of Patients with Severe Acute Respiratory Syndrome

Article

作者: Niazi, Mohammad ; Tarkhan, Amneh H. ; Khaleel, Anas ; Zakariya, Abdullah Bassam ; Qinna, Nidal A. ; Dayyih, Wael Abu

Abstract:

Background Coronaviruses are emerging threats for human health, as demonstrated by the ongoing coronavirus disease 2019 (COVID-19) pandemic that is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SARS-CoV-2 is closely related to SARS-CoV-1, which was the cause of the 2002–2004 SARS outbreak, but SARS-CoV-1 has been the subject of a relatively limited number of studies. Understanding the potential pathways and molecular targets of SARS-CoV-1 will contribute to current drug repurposing strategies by helping to predict potential drug-disease associations. Methods A microarray dataset, GSE1739, of 10 SARS patients and 4 healthy controls was downloaded from NCBI’s GEO repository, and differential expression was identified using NCBI’s GEO2R software. Pathway and enrichment analysis of the differentially expressed genes was carried out using Ingenuity Pathway Analysis and Gene Set Enrichment Analysis, respectively. Results Our findings show that the drugs dexamethasone, filgrastim, interferon alfacon-1, and levodopa were among the most significant upstream regulators of differential gene expression in SARS patients, while neutrophil degranulation was the most significantly enriched pathway. Conclusion An enhanced understanding of the pathways and molecular targets of SARS-CoV-1 in humans will contribute to current and future drug repurposing strategies, which are an essential tool to combat rapidly emerging health threats.

2021-11-01·Multiple Sclerosis and Related Disorders3区 · 医学

ProspeCtive study to evaluate efficacy, safety and tOlerability of dietary supplemeNT of Curcumin (BCM95) in subjects with Active relapsing MultIple Sclerosis treated with subcutaNeous Interferon beta 1a 44 mcg TIW (CONTAIN): A randomized, controlled trial

3区 · 医学

Article

作者: Roberta Lanzillo ; Mario Quarantelli ; Vincenzo Brescia Morra ; Monica Ragucci ; Marcello Moccia ; Giovanni Vacca ; Gianluigi D'Ambrosio ; Barbara Satelliti ; Francesco Assogna ; Maria Petracca ; Antonio Carotenuto ; Antonio Capacchione

BACKGROUND:

multiple sclerosis (MS) is a complex disease sustained by several pathogenic mechanisms. As such, combination therapy strategies, targeting a range of disease mechanisms, might represent the ideal therapeutic approach. Here we investigated the efficacy of curcumin, a naturally occurring poly-phenolic phytochemical with potent anti-inflammatory and antioxidant properties, in subjects under treatment with IFN β-1a, to test the effects of this combination therapy on clinical and MRI parameters of inflammation and neurodegeneration in relapsing MS (RMS).

METHODS:

eighty active RMS were prospectively enrolled, randomized (1:1) to either the IFN-curcumin or the IFN-placebo group and followed up longitudinally with clinical and MRI assessments for 24 months. Primary endpoint was the efficacy of curcumin versus placebo as add-on therapy on new/enlarging T2 lesions in RMS subjects under treatment with subcutaneous IFN β-1a 44 mcg TIW. Efficacy on clinical parameters (relapses and disability progression), other MRI parameters of inflammation (T1 Gd-enhancing lesions, combined unique active-CUA lesions) and neurodegeneration (T1-hypointense lesions, grey matter loss and white matter microstructural damage) as well as safety and tolerability of curcumin were explored as secondary endpoints.

RESULTS:

ten subjects dropped out from the study by month 12 (6 in the IFN-curcumin group and 4 in the IFN-placebo group), and 27 by month 24 (11 in the IFN-curcumin group and 16 in the IFN-placebo group). Although no between-group difference was present in terms of proportion of subjects free from new/enlarging T2 lesions, a lower proportion of patients with CUA lesions was noted at month 12 in the IFN-curcumin group in comparison with the IFN-placebo group (7.5% vs 17.5%, χ² test p= 0.0167). This result was not confirmed at month 24. The statistical analysis failed to reveal any difference between the two treatment groups - IFN-curcumin and IFN-placebo - in terms of relapses, disability progression, other MRI metrics of inflammation and MRI changes suggestive of ongoing neurodegeneration. No difference in the rate and nature of adverse events was observed between the two treatment groups.

CONCLUSION:

Although the study drop-out rate was too high to allow definite conclusions, our findings suggest that curcumin might add to IFN β-1a efficacy on radiological signs of inflammation in MS, while it did not seem to exert any neuroprotective effect as assessed by clinical and MRI parameters. (NCT01514370).

2020-03-01·Biotechnology and applied biochemistry4区 · 工程技术

Evaluating the ion exchange chromatography for matrix‐assisted PEGylation and purification of consensus interferon

4区 · 工程技术

Article

作者: Akram, Muhammad ; Ahmed, Nadeem ; Azam, Farhana ; Tahir, Saad ; Khan, Mohsin Ahmad ; Zafar, Ahmad Usman ; Bajwa, Fakiha

Abstract:

Scientists have implemented protein‐PEGylation technology for boosting‐up the pharmacokinetics and stability of recombinant therapeutic proteins. In the present study, (a) matrix‐assisted PEGylation was compared with solution‐phase PEGylation and (b) matrix‐assisted PEGylation was performed with different ion exchange resins for impact of chromatography medium on yield and purity of PEGylated product. DEAE Sepharose CL 6B, DEAE Fracto gel, and Macro cap Q ion exchange chromatography medium were compared for on column PEGylation and purification of cIFN. A MSC‐PEG of 12.0 KDa was selected. cIFN was bound to ion exchange medium, and PEG solution was passed through resin for 180 Min, and protein was eluted by sodium chloride linear gradient. Yield and purity for mono‐PEGylated cIFN with Macro cap Q matrix was 75% and 99%, respectively, whereas for DEAE Sepharose was 45% and 60%. DEAE Fracto gelTM purity was 85% with 50% yield of mono‐PEGylated cIFN. Further investigation of in vitro biological activities demonstrated that about 30% antiviral activity was reduced as compared to unmodified cIFN. However, thermal stability was significantly improved. The present study proved that matrix‐assisted PEGylation can improve the yield and purity of mono‐PEGylated product, and Macro Cap resin provided the highest yield of a homogeneous product.In present study, (a) matrix‐assisted PEGylation was compared with solution‐phase PEGylation and (b) matrix‐assisted PEGylation was performed with different ion exchange resins for impact of chromatography medium on yield and purity of PEGylated product. Matrix‐assisted PEGylation increases the yield of mono‐PEGylated product and further Macro CapTM produced highest yield and purity of PEGylated cIFN.

项与 INTERFERON ALFACON-1 相关的新闻（医药）

2023-06-29

·生物制药小编

前FDA及业界临床、CMC专家：注射剂兼容性和使用中稳定性研究

本次网络研讨会由全球法规监管咨询服务公司DataRevive（德顺达）和欧洲CDMO公司Ardena联合举办，来自前FDA和业界的临床、监管专家和数据科学家将共同分析有关注射剂使用中稳定性研究的监管环境，并探讨相关的WHO、EMA、FDA 和 USP 指导文件。此外，研讨会也将讨论适用于早期临床试验中的IV兼容性和使用中稳定性研究的主要设计参数。专家们还将提供多个案例研究，探讨不同场景下的实际操作。（详情见下方海报）您将从四位资深CMC、临床专家和数据科学家的对谈中了解到有关I期和II期临床试验中注射剂使用中稳定性研究的设计和执行经验，以及该领域的核心监管要求和挑战，以确保注射药物在管理过程中的质量和安全。嘉宾介绍Kathleen B. Retterson女士在生物制剂行业拥有超过30 年的工作经验，曾任Amgen副总裁、罗德岛工厂总经理、Amgen多工厂Thousand Oaks生产基地负责人，并曾于Genzyme和Charles River担任要职，负责监督生产、质保、质控、工艺开发和供应链。她曾负责EPOGEN®、Neupogen®、Aranesp®、Neulasta®、Infergen®、Enbrel®、Cerazyme®、Fabrazyme®和Myozyme®和Myozyme®等多个顶级生物制剂的成功生产。Kristin Baird医生曾在FDA任医学官8年，在美国国家卫生研究院任医师及临床研究员15年，并曾在约翰霍普金斯医院/美国国家癌症研究所进行儿科血液/肿瘤学临床研究。她在细胞基因疗法领域有资深法规咨询经验，专精于肿瘤学及免疫学、临床研究和BLA审评。Baird医生在天普大学医学院获得医学博士学位。Kelly Van Looveren是 Ardena的Senior CMC Writer，负责为客户提供法规监管建议、撰写科学报告和申报资料。Kelly拥有生物医学生物技术博士学位，拥有深入的生物技术和大分子领域专业知识，同时具备丰富的大型制药公司项目经验。Stef De Lombaerde 毕业于药剂师专业，并于 2018 年在根特大学获药学博士学位。之后，他在安特卫普大学医院担任放射药剂师，在静脉注射无菌制剂的 GMP 制造和质量控制方面积累了丰富经验。他在Ardena担任分析开发团队负责人，负责分析方法的实施和验证，协调各种新型药物产品（无菌和非无菌）的稳定性研究和QC测试。扫码加入群聊交流互动、问题解答、干货分享直播回看、线上下活动等关于德顺达DataReviveDataRevive (德顺达健康咨询) 是一家专业的法规监管服务公司，专注于新型小分子药物和生物制品领域，为创新药企和生物科技公司提供全球主要市场的真实世界监管、CMC、非临床、临床和GxP专业咨询服务。我们在美国、中国等地设有办公室，团队包括前FDA CMC部门及临床部门专家、业界CMC、非临床和临床领域的领军翘楚，以及拥有丰富法规监管经验的项目管理精英。我们与全球客户携手合作，致力于加速产品上市进程，从药品开发的最初阶段到批准后的监管支持，始终秉持高质量、高效率的服务。更多资讯，请访问 www.data-revive.com 点击阅读原文，立即报名~

基因疗法临床1期细胞疗法

100 项与 INTERFERON ALFACON-1 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02744	INTERFERON ALFACON-1	L03AB09	DB00069

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适应症	国家/地区	公司	日期
慢性丙型肝炎	欧盟	Astellas Pharma Europe Ltd.	1999-02-01
慢性丙型肝炎	冰岛	Astellas Pharma Europe Ltd.	1999-02-01
慢性丙型肝炎	列支敦士登	Astellas Pharma Europe Ltd.	1999-02-01
慢性丙型肝炎	挪威	Astellas Pharma Europe Ltd.	1999-02-01
丙型肝炎	美国	Kadmon Pharmaceuticals LLC	1997-10-06