Pegylated interferon alpha-2a(Janssen)(Pegylated interferon alpha-2a(Janssen)) - 药物靶点：IFNAR_在研适应症：慢性乙型肝炎_专利_临床

概要

基本信息

药物类型

干扰素

别名

PegIFN-alpha2a(Janssen)

靶点

IFNAR

作用机制

IFNAR激动剂(干扰素α/β受体复合体激动剂)

治疗领域

感染消化系统疾病

在研适应症

慢性乙型肝炎

非在研适应症

慢性丙型肝炎基因型 1

原研机构

Janssen Research & Development LLC

在研机构

Janssen Research & Development LLC

非在研机构

Janssen Infectious Diseases-Diagnostics BV

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

21

项与 Pegylated interferon alpha-2a(Janssen) 相关的临床试验

EUCTR2020-002979-35-IT / Not yet recruiting临床2期

A Phase IIb Multi-Center, Randomised, Open Label Study to Assess the Efficacy and Safety of Sequential Treatment with GSK3228836 followed by Pegylated Interferon Alpha 2a in Participants with Chronic Hepatitis B Virus (B-Together) - -

开始日期2021-02-10

申办/合作机构

GlaxoSmithKline Research & Development

NCT04667104 / Completed临床2期

A Phase 2, Open-label, Single-arm, Multicenter Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Patients With Chronic Hepatitis B Virus Infection

The purpose of this study is to evaluate the efficacy in terms of hepatitis B surface antigen (HBsAg) levels of the study intervention (that is, JNJ-73763989 + JNJ-56136379 + nucleos[t]ide analog [NA] and pegylated interferon alpha-2a [PegIFN-alpha2a]).

开始日期2021-02-01

申办/合作机构

Janssen Research & Development LLC

NCT04439539 / Completed临床2期

A Phase 2, Randomized, Open-label, Multicenter Study to Evaluate Efficacy, Pharmacokinetics, Safety, and Tolerability of Treatment With JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog With or Without JNJ-56136379 in Treatment-naive Patients With HBeAg Positive Chronic Hepatitis B Virus Infection

The purpose of this study is to evaluate the efficacy of a treatment regimen of JNJ-73763989 + pegylated interferon alpha-2a (PegIFN-alpha-2a) + nucleos(t)ide analog (NA).

开始日期2020-09-14

申办/合作机构

Janssen Research & Development LLC

100 项与 Pegylated interferon alpha-2a(Janssen) 相关的临床结果

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100 项与 Pegylated interferon alpha-2a(Janssen) 相关的转化医学

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100 项与 Pegylated interferon alpha-2a(Janssen) 相关的专利（医药）

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61

项与 Pegylated interferon alpha-2a(Janssen) 相关的文献（医药）

2024-11-01·JDDG: Journal der Deutschen Dermatologischen Gesellschaft

Pegylated interferon‐α2a in cutaneous T‐cell lymphoma – a multicenter retrospective data analysis with 70 patients

Article

作者: Hansen‐Abeck, Inga ; Nicolay, Jan P. ; Tratzmiller, Sabine ; Booken, Nina ; Albrecht, Jana D. ; Mengoni, Miriam ; Assaf, Chalid ; Wobser, Marion ; Menzer, Christian ; Kött, Julian ; Dobos, Gabor ; Livingstone, Elisabeth ; Mitteldorf, Christina ; Cankaya, Rohat ; Braun, Andreas D. ; Schneider, Stefan W. ; Geidel, Glenn ; Klespe, Kai‐Christian ; Klemke, Claus‐Detlev ; Terheyden, Patrick ; Abeck, Finn

SummaryBackgroundInterferon‐alpha is an important therapeutic option for the treatment of the cutaneous T‐cell lymphomas (CTCL). Since the approved recombinant interferon‐α‐2a (IFN‐α2a) has no longer been produced since January 2020, pegylated interferon‐α2a (pegIFN‐α2a) can be used as an alternative treatment, even though it is not approved for the treatment of CTCL. The aim of this multicentre study was to generate comprehensive data on the efficacy and tolerability of pegIFN‐α2a in the treatment of CTCL.Patients and MethodsA multicenter retrospective study was conducted with 70 patients with CTCL from twelve German skin centers.ResultsIn total, 70 patients were included in the study, with 57.2% male and a mean age of 58.8 ± 14.9 years. Mycosis fungoides was present in 71.4% of cases and Sézary Syndrome in 28.6%. An overall response rate of 55.2% was observed with pegIFNα‐2a therapy. In 50% of cases, therapy was discontinued after 63.6 ± 33.5 weeks. The most common reason for discontinuation was adverse events, which occurred in 68.6% of cases and which were classified as severe in 29.2%. Blood count changes, fatigue and liver toxicity occurred most frequently.ConclusionsOur analysis provides comprehensive data on the efficacy and tolerability of pegIFNα‐2a therapy in patients with CTCL. In terms of response rates and side effect profile, pegIFNα‐2a appears to be comparable to IFN‐α2a therapy.

2023-01-01·British Journal of Haematology

Dasatinib plus Peg‐Interferon alpha 2b combination in newly diagnosed chronic phase chronic myeloid leukaemia: Results of a multicenter phase 2 study (DASA‐PegIFN study)

Article

作者: Mahon, Francois‐Xavier ; Guilhot, François ; Dubruille, Viviane ; Guilhot, Joëlle ; Ame, Shanti ; Roy, Lydia ; Giraudier, Stéphane ; Rea, Delphine ; Johnson‐Ansah, Hyacinthe ; Nicolini, Franck E. ; Lenain, Pascal ; Cayssials, Emilie ; Charbonnier, Aude ; Hermet, Eric ; Rousselot, Philippe ; Guerci‐Bresler, Agnès ; Cony‐Makhoul, Pascale ; Chomel, Jean‐Claude ; Huguet, Françoise ; Bouchet, Stéphane ; Courby, Stéphane ; Ianotto, Jean‐Christophe ; Machet, Antoine ; Coiteux, Valérie ; Etienne, Gabriel ; Escoffre‐Barbe, Martine ; Legros, Laurence

SummarySuperior rates of deep molecular response (DMR) have been reported with the combination of tyrosine kinase inhibitors and pegylated‐interferon‐alpha (Peg‐IFN) in patients with newly diagnosed chronic phase‐chronic myeloid leukaemia (CP‐CML). In this setting, this study investigated the efficacy and safety of dasatinib combined to Peg‐IFN‐α2b (Dasa‐PegIFN, NCT01872442). A total of 79 patients (age ≤65 years) started dasatinib; 61 were eligible for Peg‐IFNα‐2b add‐on therapy at month 3 for a maximum 21‐months duration. Dasatinib was continued thereafter. The primary endpoint was the cumulative rate of molecular response 4.5 log (MR4.5) by 12 months. The results are reported for the 5‐year duration of the study. Grade 3 neutropenia was frequent with the combination but did not induce severe infection (one of grade 3). Other adverse events were generally low grade (4% of grade 3–4) and expected. Seventy‐nine per cent and 61% of patients continued the Peg‐IFN until months 12 and 24, respectively. Overall, at these time points, MR4.5 rates were 25% and 38%, respectively. Thereafter, 32% and 46% of patients achieved a sustained (≥2 years) MR4.5 or MR4, respectively. This work established the feasibility and high rates of achievement of early and sustained DMR (a prerequisite for treatment‐free‐remission) with dasatinib and Peg‐IFNα‐2b combination as initial therapy.

2021-08-01·Leukemia1区 · 医学

Long-term outcome of imatinib 400 mg compared to imatinib 600 mg or imatinib 400 mg daily in combination with cytarabine or pegylated interferon alpha 2a for chronic myeloid leukaemia: results from the French SPIRIT phase III randomised trial

1区 · 医学

Article

作者: Johnson-Ansah, Hyacinthe ; Maisonneuve, Herve ; Maloisel, Frédéric ; Santagostino, Alberto ; Fouillard, Loïc ; Rigal-Huguet, Françoise ; Nicolini, Franck-Emmanuel ; Dorvaux, Véronique ; Vekhoff, Anne ; Chomel, Jean-Claude ; Bulabois, Claude-Eric ; Glaisner, Sylvie ; Alexis, Magda ; Cayuela, Jean-Michel ; Arkam, Yazid ; Zerazhi, Hacene ; Delmer, Alain ; Rea, Delphine ; Ghomari, Kamel ; Plantier, Isabelle ; Preudhomme, Claude ; Miclea, Jean-Michel ; Joly, Bertrand ; Deconinck, Eric ; Rousselot, Philippe ; Jourdan, Eric ; Gyan, Emmanuel ; Mercier, Melanie ; Gardembas, Martine ; Kiladjian, Jean-Jacques ; Coiteux, Valérie ; Etienne, Gabriel ; Guilhot, Joëlle ; Cony-Makhoul, Pascale ; Dubruille, Viviane ; Berthou, Christian ; Roy, Lydia ; Lebon, Delphine ; Cambier, Nathalie ; Legros, Laurence ; Chapiro, Jacques ; Delord, Marc ; Muller, Marc ; Caillot, Denis ; Mahon, François-Xavier ; Lenain, Pascal ; Escoffre Barbe, Martine ; Vaida, Iona ; Pollet, Bertrand ; Penot, Amélie ; Berger, Marc ; Guilhot, Francois ; Guerci-Bresler, Agnès-Paule ; Lhermitte, Ludovic ; Charbonnier, Aude

The STI571 prospective randomised trial (SPIRIT) French trial is a four-arm study comparing imatinib (IM) 400 mg versus IM 600 mg, IM 400 mg + cytarabine (AraC), and IM 400 mg + pegylated interferon alpha2a (PegIFN-α2a) for the front-line treatment of chronic-phase chronic myeloid leukaemia (CML). Long-term analyses included overall and progression-free survival, molecular responses to treatment, and severe adverse events. Starting in 2003, the trial included 787 evaluable patients. The median overall follow-up of the patients was 13.5 years (range 3 months to 16.7 years). Based on intention-to-treat analyses, at 15 years, overall and progression-free survival were similar across arms: 85%, 83%, 80%, and 82% and 84%, 87%, 79%, and 79% for the IM 400 mg (N = 223), IM 600 mg (N = 171), IM 400 mg + AraC (N = 172), and IM 400 mg + PegIFN-α2a (N = 221) arms, respectively. The rate of major molecular response at 12 months and deep molecular response (MR4) over time were significantly higher with the combination IM 400 mg + PegIFN-α2a than with IM 400 mg: p = 0.0001 and p = 0.0035, respectively. Progression to advanced phases and secondary malignancies were the most frequent causes of death. Toxicity was the main reason for stopping AraC or PegIFN-α2a treatment.

100 项与 Pegylated interferon alpha-2a(Janssen) 相关的药物交易

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研发状态

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
慢性丙型肝炎基因型 1	临床3期	奥地利	Janssen Infectious Diseases-Diagnostics BV	2010-12-01
慢性丙型肝炎基因型 1	临床3期	爱尔兰	Janssen Infectious Diseases-Diagnostics BV	2010-12-01
慢性丙型肝炎基因型 1	临床3期	瑞典	Janssen Infectious Diseases-Diagnostics BV	2010-12-01
慢性丙型肝炎基因型 1	临床3期	西班牙	Janssen Infectious Diseases-Diagnostics BV	2010-12-01
慢性丙型肝炎基因型 1	临床3期	德国	Janssen Infectious Diseases-Diagnostics BV	2010-12-01
慢性丙型肝炎基因型 1	临床3期	法国	Janssen Infectious Diseases-Diagnostics BV	2010-12-01
慢性丙型肝炎基因型 1	临床3期	波兰	Janssen Infectious Diseases-Diagnostics BV	2010-12-01
慢性丙型肝炎基因型 1	临床3期	比利时	Janssen Infectious Diseases-Diagnostics BV	2010-12-01
慢性丙型肝炎基因型 1	临床3期	澳大利亚	Janssen Infectious Diseases-Diagnostics BV	2010-12-01
慢性丙型肝炎基因型 1	临床2期	英国	Janssen Infectious Diseases-Diagnostics BV	2010-12-01

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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


NCT04667104 (PENGUIN, CTgov)	临床2期	慢性乙型肝炎	48	JNJ-3989+PegIFN-alpha2a+JNJ-6379 (TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA)	蓋齋鬱憲繭選糧齋齋觸(齋齋構淵壓製淵願遞膚) = 壓淵繭廠壓願蓋積鬱積齋廠鑰網壓製蓋夢鹽蓋 (鹹製選壓獵鏇獵鹹襯窪, 顧廠醖鹽顧積糧膚築窪 ~ 鹹鹹憲廠獵淵遞餘網製) 更多	-	2024-07-03
				JNJ-73763989+JNJ-56136379 (TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA)	艱選願窪繭憲構齋膚鹹(積積窪憲獵顧廠淵壓築) = 顧壓築糧糧夢鏇繭齋獵遞築糧積願襯積遞願簾 (鑰構獵簾鬱選範蓋淵餘, 願憲遞鑰艱艱製鬱窪範 ~ 憲廠鹽衊壓壓網齋醖簾) 更多
IAS2015	N/A	HIV感染 \| 丙型肝炎	-	pegIFN-a 2a 180 mg/week	蓋襯膚鑰築鏇夢膚鹽壓(餘膚顧觸窪獵醖壓鏇範) = 襯網積夢顧醖觸遞鬱醖鹹構鹽壓觸網窪簾鏇衊 (願築繭鏇餘餘簾壓範繭 ) 更多	-	2015-01-01
				pegIFN-a 2a 360 mg/week	蓋襯膚鑰築鏇夢膚鹽壓(餘膚顧觸窪獵醖壓鏇範) = 鬱鹽網鏇憲獵衊網餘糧鹹構鹽壓觸網窪簾鏇衊 (願築繭鏇餘餘簾壓範繭 ) 更多
NCT00535847 (CTgov)	临床2期	丙型肝炎	117	Pegylated interferon alfa 2a+Telaprevir+Ribavirin (Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week)	艱鹽窪獵範範顧願觸觸(糧淵衊築蓋構夢憲齋範) = 顧願淵鑰製顧築蓋範遞艱網鏇鏇積衊襯醖衊醖 (製淵選鏇網襯構築製鹽, 範窪夢鹽鏇觸醖鹹鬱製 ~ 壓衊醖夢製鏇範鏇夢襯) 更多	-	2011-07-25
				Pegylated interferon alfa 2a+Telaprevir+Ribavirin (Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week)	艱鹽窪獵範範顧願觸觸(糧淵衊築蓋構夢憲齋範) = 構齋蓋糧繭遞範選構淵艱網鏇鏇積衊襯醖衊醖 (製淵選鏇網襯構築製鹽, 製鬱網網淵鹹繭鹽獵糧 ~ 製淵夢網鹹艱蓋積構憲) 更多
NCT00627926 (CTgov)	临床3期	慢性丙型肝炎基因型 1	1,095	Placebo+Pegylated Interferon Alfa 2a+Ribavirin (PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week)	襯艱醖淵憲淵鏇製構醖(壓遞繭構觸艱鑰範窪範) = 艱選鏇醖積糧窪觸糧築鬱選壓簾淵憲觸簾廠夢 (鬱鏇築夢繭觸餘構構鏇, 膚顧鑰願構廠繭窪齋廠 ~ 壓網網鹽遞選糧窪糧繭) 更多	-	2011-07-21
				Placebo+Pegylated Interferon Alfa 2a+Telaprevir+Ribavirin (Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week)	襯艱醖淵憲淵鏇製構醖(壓遞繭構觸艱鑰範窪範) = 獵顧簾糧壓選鬱糧糧膚鬱選壓簾淵憲觸簾廠夢 (鬱鏇築夢繭觸餘構構鏇, 鬱廠顧齋襯艱淵鑰鑰鹹 ~ 窪衊觸淵糧醖網獵夢獵) 更多