This is a prospective study to evaluate the safety and efficacy of Sintilimab (PD-1 antibody) in sequential combination with Peg-IFNα-2b in NA-supressed CHB patients who had previously received Peg-IFNα therapy.

开始日期2024-06-15

申办/合作机构

中国人民解放军总医院第五医学中心

ChiCTR2400080005

/ Suspended早期临床1期

A prospective study to evaluate the safety and efficacy of TACE combined with Peg IFNa-2b+NAs+PD-1 inhibitor in patients with HBV-related hepatocellular carcinoma after radical resection

开始日期2024-02-11

申办/合作机构

厦门齐安中医院有限公司

ChiCTR2300074909

/ Recruiting临床1期IIT

Evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of nebulized inhalation of pegylated interferon alpha-2b injection in healthy adult subjects

开始日期2023-08-13

申办/合作机构-

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100 项与聚乙二醇干扰素α-2b生物类似药(Zydus Cadila Healthcare Ltd.) 相关的专利（医药）

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734

项与聚乙二醇干扰素α-2b生物类似药(Zydus Cadila Healthcare Ltd.) 相关的文献（医药）

2025-02-01·PEDIATRIC INFECTIOUS DISEASE JOURNAL

Dynamic Changes of Growth and Thyroid Function in Young Children With Chronic Hepatitis B Treated With Peginterferon Monotherapy

Article

作者: Mao, Chuangjie ; Hu, Rong ; He, Qiufeng ; Huang, Liang ; Deng, Yang ; Yang, Song ; Zeng, Yilan ; Duan, Fangfang ; Cheng, Jun ; Chen, Zhili

Background::

Peginterferon (PegIFN) has shown promising results in the treatment of chronic hepatitis B (CHB). This study aimed to evaluate the effects of PegIFN α-2b on growth and thyroid function in young children with CHB.

Methods::

A retrospective study was performed by extracting clinical data from children with CHB who received PegIFN α-2b monotherapy at the Public Health Clinical Center of Chengdu between June 2017 and December 2020. Mean, SD, independent samples t test and 1-way repeated analysis of variance were used to evaluate relevant data.

Results::

A total of 62 children were included in this study. Overall, significant differences were observed in the weight-for-age z score (WAZ), height-for-age z score (HAZ) and body mass index-for-age z score (BAZ) at different time points (P < 0.001). WAZ, HAZ and BAZ were not affected by PegIFN α-2b at 24 weeks of treatment (all P > 0.05). WAZ, HAZ and BAZ at the end of treatment and 48 weeks after treatment; WAZ at 96 weeks after treatment were lower than baseline levels (all P < 0.05). No statistical differences were found in HAZ and BAZ at 96 weeks after treatment compared with baseline. Thyroid dysfunction developed in 17.7% of children during the treatment. Thyroid dysfunction was transient and had no effect on growth.

Conclusions::

PegIFN α-2b has inhibitory effects on growth and can increase the incidence of thyroid dysfunction in young children with CHB. These effects are generally reversible with the cessation of therapy, although WAZ had not returned to baseline after 96 weeks of observation.

2024-11-01·Graefe's Archive for Clinical and Experimental Ophthalmology

Comparison of postoperative topical interferon-α2b versus intraoperative mitomycin C for pterygium recurrence prevention: a randomized clinical trial

Article

作者: Mahmoudi, Hadi ; Moghadam, Reza Soltani ; Leili, Ehsan Kazemnezhad ; Akbari, Mitra ; Medghalchi, Abdolreza

PURPOSE:

To evaluate the effect of postoperative interferon-alpha 2b (IFN-α2b) ophthalmic drops versus intraoperative mitomycin-c (MMC) on preventing pterygium recurrence.

METHODS:

This prospective randomized clinical trial was conducted on patients who were candidates for pterygium surgery. A total of 75 patients were included in the study from December 2021 to December 2022, of which 64 patients (one eye each) were examined and analyzed based on the inclusion criteria. Then the patients were randomly assigned to control groups, intra-operative MMC (32 patients) and the intervention group, IFN-α2b drops after the operation (32 patients). All patients underwent pterygium surgery using the rotational conjunctival flap method.

RESULTS:

In terms of pterygium grading, 8 (12.5%), 25 (39.06%), and 31 (48.44%) eyes were in grades 1, 2, and 3, respectively. The average size of the pterygium was 3.6 ± 0.7 mm. The grade and size of pterygium had the same distribution in the two groups. There was no statistically significant difference between the two groups in the level of post-operative clinical inflammation. The present study showed no significant difference in complications between the two groups (p = 0.999). The recurrence rate in the control group was 9.4% (3 eyes), and 0% (no recurrence) in the intervention group (p = 0.119).

CONCLUSIONS:

interferon-alpha 2b group did not show a statistically significant difference in preventing pterygium recurrence compared to the mitomycin C group. The post-surgery administration of IFN-α 2b drops can effectively prevent pterygium recurrence with a comparable and even more compelling effect than MMC during surgery.

2024-07-01·Antiviral research

Quantitative HBeAg is a strong predictor of HBeAg loss among patients receiving pegylated interferon

Article

作者: Lee, Yin Mei ; Holzmayer, Vera ; Shen, Liang ; Tan, Poh Seng ; Tan, Jessica ; Tay, Amy ; Phyo, Wah Wah ; Anderson, Mark ; Ngu, Jing Hieng ; Lim, Seng Gee ; Muthiah, Mark ; Khine, Htet Toe Wai ; Huang, Daniel Q ; Lee, Guan Huei ; Ahmed, Taufique ; Dan, Yock Young ; Kuhns, Mary C ; Butler, Emily K ; Cloherty, Gavin ; Yang, Wei Lyn ; Lee, Chris ; Gersch, Jeffrey ; McNamara, Anne L ; Chang, Jason

BACKGROUND:

HBeAg loss is an important endpoint for antiviral therapy in chronic hepatitis B (CHB), however there are no reliable biomarkers to identify patients who will respond to the addition of pegylated interferon to nucleos(t)ide analogue (NA) therapy.

AIM:

To evaluate the use of serum biomarkers to predict HBeAg loss.

METHODS:

HBeAg positive CHB participants on NAs who switched-to or added-on 48 weeks pegylated interferon alpha2b (clinicaltrial.gov NCT01928511) were evaluated at week 72 for HBeAg loss. The predictive ability of qHBeAg, qHBsAg, HBV RNA and clinical variables for HBeAg loss were investigated.

RESULTS:

HBeAg loss occurred in 15/55 (27.3%) participants who completed 48 weeks of pegylated interferon. There was a lower baseline qHBeAg (1.18 IU/mL [2.27] versus 10.04 IU/mL [24.87], P = 0.007) among participants who lost HBeAg. Baseline qHBeAg (OR = 0.15, 95% CI 0.03-0.66, P = 0.01) and detectable HBV DNA at baseline (OR = 25.00, 95% CI 1.67-374.70, P = 0.02) were independent predictors of HBeAg loss. In addition, on-treatment qHBeAg was also a strong predictor of HBeAg loss (OR = 0.39, 95% CI 0.18-0.81, P = 0.012). The models combining detectable baseline HBV DNA with baseline (C-statistic 0.82) and on-treatment (C-statistic 0.83) had good accuracy for predicting HBeAg loss. A rise in qHBeAg ≥ 10 IU/ml was a predictor of flare (ALT ≥ 120 U/ml) on univariable analysis but not after adjustment for treatment arm.

CONCLUSIONS:

Baseline and on-treatment qHBeAg is a useful biomarker that can identify participants on NA therapy who may benefit from adding or switching to pegylated interferon.

项与聚乙二醇干扰素α-2b生物类似药(Zydus Cadila Healthcare Ltd.) 相关的新闻（医药）

2024-07-22

·GlobeNewswire-Health Care

Aligos Therapeutics Announces Clinical Collaboration with Xiamen Amoytop Biotech Co., Ltd.

Amoytop to sponsor a Phase 1b exploratory clinical study evaluating the efficacy and safety of ALG-000184 in combination with PEGBING® (Mipeginterferon alfa-2b) in CHB patients SOUTH SAN FRANCISCO, Calif., July 22, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that it has entered into a clinical trial collaboration agreement with Xiamen Amoytop Biotech Co., Ltd. (“Amoytop”). Under the terms of the agreement, Amoytop will sponsor and perform a Phase 1b exploratory clinical study evaluating the efficacy and safety of ALG-000184 in combination with PEGBING® (Mipeginterferon alfa-2b) in chronic hepatitis B (CHB) patients in China. The clinical study is expected to begin after approval by the National Medical Products Administration in China. “We are pleased to build on our existing relationship with Amoytop, as they have proven to be a valuable partner,” stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer at Aligos Therapeutics. “We look forward to initiating this exploratory study to evaluate the combination of ALG-000184 with PEGBING®, one of the approved drugs for CHB patients in China, to assess the potential benefits of a combinatory approach.” ALG-000184 is a potent best/first-in-class oral small molecule capsid assembly modulator (CAM-E) being developed for CHB. It is designed to exploit the dual role of CAMs by disrupting hepatitis B cccDNA levels and its derived transcripts by reducing expression of viral markers such as DNA, RNA, and the relevant antigens (HBsAg, HBeAg, HBcrAg). Phase 1a studies have demonstrated after single and multiple daily doses that ALG-000184 was well-tolerated, with no safety signals observed, and demonstrated linear pharmacokinetics (PK) and excellent antiviral activity. In longer term Phase 1b studies of ALG-000184 300mg x ≤96 weeks ± entecavir (ETV), ALG-000184 monotherapy has demonstrated best-in-class reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg without viral breakthrough to date. PEGBING®, independently developed by Amoytop, is the world's first 40kD pegylated interferon α-2b injection. With dual effects of inhibiting viral replication and enhancing immunity, PEGBING® is mainly used in the clinical treatment of viral hepatitis and is the first-line drug for the antiviral treatment of chronic hepatitis B, which plays an important role in improving the clinical cure rate of hepatitis B and reducing the risk of liver cancer. “We are pleased to deepen our cooperation in the field of liver disease treatment and look forward to working together to provide a new treatment solution for patients in need,” said Sun Li, Chairman and Chief Executive Officer at Amoytop. “Amoytop is committed to further optimizing the chronic hepatitis B combination treatment pathway and hopes that the cooperation will lead to better clinical value drugs and drug combinations.” The Phase 1b study will be a randomized, double blinded, active controlled study to evaluate the safety, pharmacokinetics, and antiviral activity of oral once daily doses of 300 mg ALG-000184 + PEGBING® + entecavir (ETV) compared with 300 mg ALG-000184 + ETV or PEGBING® + ETV in treatment naïve or currently-not-treated HBeAg-positive and nucleos(t)ide analog (NA) suppressed HBeAg-negative subjects with CHB for 48 weeks. About Aligos Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver and viral diseases. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best-in-class therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses. For more information, please visit www.aligos.com or follow us on LinkedIn or X. About Xiamen Amoytop Biotech Co., Ltd. Xiamen Amoytop Biotech Co., Ltd. is an innovative biopharmaceutical company and a listed company on the Science and Technology Innovation Board (SSE STAR Market) in China, specializing in R&D, manufacturing and marketing of regular and long-acting recombinant protein drugs. Focusing on the R&D of immune-related cytokine medicines, Amoytop is committed to becoming a leader in solving cytokine medicine-based systemic immune problems, providing better solutions for major diseases (such as viral hepatitis, malignant tumors) and immunotherapy. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including, without limitation, statements regarding Aligos’ financial results and performance as well as research and development activities, including regulatory status and the timing of announcements and updates relating to our regulatory filings and clinical trials. Such forward-looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, and other matters that could affect the sufficiency of Aligos’ capital resources to fund operations. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2024 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events. Aligos Therapeutics Investor Contact Jordyn TaraziVice President, Investor Relations & Corporate Communications+1 (650) 910-0427jtarazi@aligos.com Media Contact Michael FitzhughLifeSci Communicationsmfitzhugh@lifescicomms.com Xiamen Amoytop Biotech Co., Ltd. Investor Contact Liu Peiyu联系电话：86592-6889118邮箱：ir@amoytop.com Media Contact Wu Xueyan联系电话：86592-6889127邮箱：wxy@amoytop.com

临床1期引进/卖出临床2期

2024-07-22

·Firstwordpharma

Aligos links up with Amoytop to test Hep B combo in China

After its initial chronic hepatitis B (CHB) candidate failed in the clinic a few years ago, Aligos Therapeutics is now moving forward with a different approach. The biotech on Monday partnered with Xiamen Amoytop Biotech to test its next CHB hopeful, ALG-000184, in combination with the latter’s Pegbing (mipeginterferon alfa-2b).ALG-000184 is an oral small molecule capsid assembly modulator designed to disrupt the virus’s covalently closed circular DNA (cccDNA) levels by suppressing viral marker expression. Amoytop’s pegylated interferon α-2b injection is approved in China as a first-line antiviral treatment for CHB. Amoytop will be in charge of running the Phase Ib study, which will enrol CHB treatment-naïve patients in China and is expected to start following clearance from the country’s regulator. Patients who are positive for HBeAg and currently are not receiving treatment, as well as nucleos(t)ide analog suppressed HBeAg-negative patients, are also eligible for the trial. The randomised, double-blind study will evaluate the safety and efficacy of an oral, once-daily 300-mg dose of ALG-000184 plus Pegbing and the antiviral entecavir against two other combos: Aligo’s experimental treatment with entecavir, and Amoytop’s drug with entecavir.Aligos’ first attempt at a CHB treatment, ALG-010133, was an S-antigen transport-inhibiting oligonucleotide polymer. The molecule failed to significantly reduce hepatitis B virus surface antigen levels in a Phase I study.

临床1期上市批准寡核苷酸siRNA临床申请

2023-11-10

·美通社

艾棣维欣乙肝治疗性疫苗相关临床研究结果发表

苏州2023年11月10日 /美通社/ -- 近日，艾棣维欣生物（Advaccine）发布公告，公司合作单位复旦大学与浙江大学医学院附属第一医院等多家临床医院在同行评议的学术期刊《Journal of Clinical and Translational Hepatology》（《临床与转化肝脏病学杂志》）上发表了与公司乙肝治疗性疫苗ADV311项目有关的研究者发起的临床研究（IIT）的论文" Immunomodulatory and Antiviral Therapy Improved Functional Cure Rate in CHB Patients with High HBsAg Level Experienc ed NA "。乙肝治疗性疫苗IIT临床研究经Journal of Clinical and Translational Hepatology发表该研究为前瞻性、多中心、随机对照的临床研究，在浙江大学医学院附属第一医院感染病科、复旦大学华山医院感染科、上海交通大学医学院附属瑞金医院感染科、四川大学华西医院感染性疾病中心、北京302医院国际肝病诊疗中心、北京大学第一医院感染疾病科、华中科技大学同济医学院附属协和医院感染性疾病科、山东大学齐鲁医院肝病科、西安交通大学第一附属医院感染性疾病科9个临床中心共计入组了310名乙型肝炎e抗原（HBeAg）阳性的慢性乙型肝炎（Chronic hepatitis B，CHB）患者。临床研究采用了ADV311作用机制等效版本的临床方案设计，研究者评估了在已接受聚乙二醇干扰素α-2b（PEG IFN-α2b）和富马酸替诺福韦酯（TDF）治疗的慢性乙型肝炎患者中，接受与不接受粒细胞－巨噬细胞集落刺激因子（GM-CSF）和乙肝疫苗治疗的乙型肝炎表面抗原（HBsAg）清除情况。临床试验的结果，治疗组（TDF+PEG IFN-α2b+GM-CSF+乙肝疫苗组）在第 48 周的累积功能性治愈的比例（HBsAg 清除率）达 41.1%，累积 HBsAg 血清学转换率达 33.9%。此研究结果表明，在入组的患者中，免疫调节联合抗病毒治疗方案有效地降低了HBsAg 水平并提高了HBsAg 清除率。据公告披露，艾棣维欣ADV311是针对慢性乙型肝炎开发的治疗性疫苗，ADV311由源自乙肝表面抗原的重组蛋白及CA02的佐剂系统（具体包括GM-CSF、IFN-α及铝佐剂）组成。本次临床研究结果提高了慢性乙肝患者功能性治愈的比例（即HBsAg清除率），提升了免疫调节联合抗病毒治疗方案的学术影响力，有利于ADV311项目后续的研发与应用。关于乙型肝炎随着乙型肝炎疫苗和乙型肝炎免疫球蛋白等预防和阻断措施的普及，以及强效抗病毒药物的应用，HBV感染的防治取得了长足的进步。然而，全世界仍然有超过2.5亿-2.7亿慢性HBV感染者人存在慢性感染，每年约超过65万人死于HBV相关终末期肝病，包括肝功能衰竭、肝硬化和肝细胞癌（HCC）。在中国，超过6.1%的人口，约8600万人长期携带乙肝病毒（HBV），每年新发肝癌患者人数超过40万。目前乙肝治疗主要通过核苷类似物（NAs）和干扰素-α等方式，虽然可以实现对HBV病毒复制的抑制，但难以实现更高比例的功能性治愈，即HBV表面抗原（HBsAg）的清除，从而减少肝硬化和肝细胞癌（HCC）的发生。乙肝功能性治愈存在巨大的未满足临床需求。关于艾棣维欣艾棣维欣（证券代码：874055.NQ）作为一家中国领先的创新疫苗与生物制药企业，基于抗原技术平台、佐剂技术平台、药物递送技术平台，正在开发一系列创新疫苗和药物。目前公司的在研产品覆盖传染病、癌症、微针递送等方向。

疫苗临床结果临床研究

100 项与聚乙二醇干扰素α-2b生物类似药(Zydus Cadila Healthcare Ltd.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

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适应症	国家/地区	公司	日期
尖锐湿疣	日本	Zydus Cadila Healthcare Ltd.	2014-01-01
乙型肝炎	日本	Zydus Cadila Healthcare Ltd.	2014-01-01
丙型肝炎	日本	Zydus Cadila Healthcare Ltd.	2014-01-01

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适应症	最高研发状态	国家/地区	公司	日期
新型冠状病毒感染	临床2期	墨西哥	Zydus Lifesciences Ltd.	2020-08-11

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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


EHA2024	N/A	真性红细胞增多症 \| 原发性血小板增多症	81	Peg-IFN-α-2b	製鹽糧築願網餘艱範鏇(積醖繭淵網顧選艱構衊) = 齋範醖築鏇製製鹽鹹襯夢餘淵蓋鑰顧鑰夢範餘 (鬱廠淵鏇艱鹽餘衊構觸 )	积极	2024-05-14
REAL-WORLD EXPERIENCE OF PEGYLATED INTERFERON ALFA-2B (EHA2024)	N/A	骨髓增生性疾病 JAK2V617F mutation \| CALR mutation \| MPL mutation	68	PEG IFNα-2b 180μg once a week	簾鹹鑰築願構餘淵製窪(襯願簾範範鏇範醖鏇鹽) = 餘窪醖築廠淵願膚鏇醖鹹憲鑰範顧襯襯選窪製 (選觸鹽襯餘鏇夢積夢顧 ) 更多	积极	2024-05-14
ASCO_GI2018	N/A	不可切除的肝内胆管癌	21	Hepatic arterial infusion chemotherapy (HAIC) using 5-fluorouracil and subcutaneous PEG-IFN α-2b	壓觸醖選膚壓艱廠蓋築(積選壓觸鹹選願蓋鬱簾) = All adverse reactions were controllable by temporary suspension of treatment. Serious complications and treatment related deaths were not observed. 簾淵遞積蓋窪淵醖醖醖 (糧築淵蓋淵壓鏇醖願鏇 )	积极	2018-02-26
AACR2012	临床1/2期	黑色素瘤	17	Decitabine	範鹽遞顧鑰鑰築襯糧糧(獵願糧壓壓淵淵製齋鹹) = 遞壓製範艱蓋製簾憲鬱鑰醖餘簾蓋網範夢糧顧 (築廠構觸鹽選顧蓋膚選 ) 更多	-	2012-04-15
IAS2003	N/A	HIV感染 \| 慢性丙型肝炎	121	peg INF plus RBV	壓範網鏇襯網醖鹹憲衊(窪鑰獵鏇獵鹽顧衊築觸) = 鏇範憲憲築網獵積膚願艱鏇顧鏇選鹽醖範鹽範 (構鏇選窪夢窪夢襯襯築 )	-	2003-01-01