Pegylated synthetic human c-peptide(Pegylated synthetic human c-peptide) - 药物靶点：C-peptide x NGF_专利_临床

概要

基本信息

药物类型

合成多肽

别名

C-peptide long-acting、Ersatta、PEGylated C-peptide

+ [3]

靶点

C-peptide x NGF

作用机制

C-peptide 调节剂(Connecting peptide modulators)、NGF刺激剂(神经生长因子刺激剂)、Adenosine triphosphatase stimulants

治疗领域

免疫系统疾病神经系统疾病内分泌与代谢疾病

在研适应症-

非在研适应症

1型糖尿病糖尿病周围神经病变

原研机构

Cebix, Inc.

在研机构-

非在研机构

Cebix, Inc.

最高研发阶段无进展临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 63678

关联

2

项与 Pegylated synthetic human c-peptide 相关的临床试验

NCT01681290 / Completed临床2期

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CBX129801 (Ersatta™), Long-Acting Synthetic C-Peptide, in Type 1 Diabetes Mellitus Subjects With Mild to Moderate Diabetic Peripheral Neuropathy

The purpose of the study is to determine the beneficial effects of CBX129801 (PEGylated synthetic human C-peptide) following weekly subcutaneous administration for 12 months in type 1 diabetes mellitus patients (T1DM) with mild to moderate diabetic peripheral neuropathy (DPN).

开始日期2012-10-01

申办/合作机构

Cebix, Inc.

NCT01293461 / Completed临床1/2期

A Randomized, Blinded, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CBX129801 (Long-Acting Synthetic C-Peptide) After Subcutaneous Administration in Patients With Type 1 Diabetes Mellitus

The purpose of this study is to assess safety and tolerability and determine the pharmacokinetics of subcutaneous single and multiple (up to 12) dose administration of CBX129801 (long-acting synthetic C-peptide) in type 1 diabetes patients.

开始日期2011-04-01

申办/合作机构

Cebix, Inc.

100 项与 Pegylated synthetic human c-peptide 相关的临床结果

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100 项与 Pegylated synthetic human c-peptide 相关的转化医学

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100 项与 Pegylated synthetic human c-peptide 相关的专利（医药）

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9

项与 Pegylated synthetic human c-peptide 相关的文献（医药）

2024-11-01·Orthopaedic Journal of Sports Medicine

Microfracture Versus a Porcine-Derived Collagen-Augmented Chondrogenesis Technique for Treating Knee Cartilage Defects: Results at Midterm Follow-up

Article

作者: Wang, Joon Ho ; Chun, Churl Hong ; Kang, Seung-Baik ; In, Yong ; Chang, Moon Jong ; Kim, Man Soo

Background: Damaged cartilage can be treated using the creation of microfractures (MFxs) or the porcine-derived collagen-augmented chondrogenesis technique (C-ACT). Purpose: To provide the midterm results of a multicenter randomized controlled trial comparing MFx and C-ACT for knee cartilage defects. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: The study cohort comprised 36 patients with medial femoral condyle cartilage defects who were followed up for 6 years with clinical and magnetic resonance imaging data (n = 14 treated with MFx alone, n = 22 treated with C-ACT). Clinical outcomes were assessed preoperatively and at 1, 2, and 6 years postoperatively using a visual analog scale (VAS) for pain, the Knee injury and Osteoarthritis Outcome Score (KOOS), and the International Knee Documentation Committee (IKDC) subjective score. Magnetic resonance imaging scans were performed preoperatively and at 1 and 6 years postoperatively, and the repaired cartilage tissue was evaluated using the magnetic resonance observation of cartilage repair tissue (MOCART) score. The repaired tissue/reference cartilage ratio was quantified using T2 mapping. Adverse events during follow-up were also evaluated. Results: In both groups, the VAS pain score improved and was maintained for 1, 2, and 6 years postoperatively compared with preoperatively ( P < .05 for all). Although there were no significant differences between groups in the VAS pain, KOOS, or IKDC scores at any time point, the change in the IKDC—Activities of Daily Living subscore from preoperatively to 6 years postoperatively was better in the C-ACT group than the MFx group ( P = .0423). At 6 years postoperatively, the MOCART assessment showed superior results regarding the surface of the repair tissue in the C-ACT group compared with the MFx group ( P = .0288). There were no differences between the groups in the total MOCART score or other subscores. Conclusion: The study results suggest that C-ACT has similar effects to MFx in improving pain, joint function, and imaging findings and may be superior to MFx in improving daily life function and improving the quality of the surface of the cartilage tissue. Registration: ClinicalTrials.gov identifier: NCT02539030.

2020-06-01·Arthroscopy: The Journal of Arthroscopic & Related Surgery1区 · 医学

Microfractures Versus a Porcine-Derived Collagen-Augmented Chondrogenesis Technique for Treating Knee Cartilage Defects: A Multicenter Randomized Controlled Trial

1区 · 医学

Article

作者: Chang, Chong Bum ; Wang, Joon Ho ; Song, In Soo ; Yoo, Jae Doo ; Chon, Je-Gyun ; Choi, Nam Yong ; Chun, Churl Hong ; Kang, Seung-Baik ; Kim, Jin Goo ; Ha, Jeong Ku ; In, Yong ; Kim, Myung Ku ; Kim, Man Soo ; Moon, Chan Woong

PURPOSEThe purpose of this study was to evaluate the clinical efficacy and safety of treating patients with a cartilage defect of the knee with microfractures and porcine-derived collagen-augmented chondrogenesis technique (C-ACT).METHODSOne hundred participants were randomly assigned to the control group (n = 48, microfracture) or the investigational group (n = 52, C-ACT). Clinical and magnetic resonance imaging (MRI) outcomes were assessed 12 and 24 months postoperatively for efficacy and adverse events. Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) assessment was used to analyze cartilage tissue repair. MRI outcomes for 50% defect filling and repaired tissue/reference cartilage (RT/RC) ratio were quantified using T2 mapping. Clinical outcomes were assessed using the visual analogue scale (VAS) for pain and 20% improvement, minimal clinically important difference (MCID), and patient acceptable symptom state for Knee Injury and Osteoarthritis Outcome Score (KOOS) and the International Knee Documentation Committee score.RESULTSMOCART scores in the investigation group showed improved defect repair and filling (P = .0201), integration with the border zone (P = .0062), and effusion (P = .0079). MRI outcomes showed that the odds ratio (OR) for ≥50% defect filling at 12 months was statistically higher in the investigation group (OR 3.984, P = .0377). Moreover, the likelihood of the RT/RC OR becoming ≥1 was significantly higher (OR 11.37, P = .0126) in the investigation group. At 24 months postoperatively, the OR for the VAS 20% improvement rate was significantly higher in the investigational group (OR 2.808, P = .047). Twenty-three patients (52.3%) in the control group and 35 (77.8%) in the investigation group demonstrated more than the MCID of KOOS pain from baseline to 1 year postoperatively, with a significant difference between groups (P = .0116).CONCLUSIONIn this multicenter randomized trial, the addition of C-ACT resulted in better filling of cartilage defect of the knee joint.LEVEL OF EVIDENCELevel Ⅰ, Multicenter Randomized Controlled Trial.

2016-04-01·Diabetes Care1区 · 医学

Long-Acting C-Peptide and Neuropathy in Type 1 Diabetes: A 12-Month Clinical Trial

1区 · 医学

Article

作者: Foyt, Howard ; Wahren, John ; Arezzo, Joseph C. ; Daniels, Mark

OBJECTIVELack of C-peptide in type 1 diabetes may be an important contributing factor in the development of microvascular complications. Replacement of native C-peptide has been shown to exert a beneficial influence on peripheral nerve function in type 1 diabetes. The aim of this study was to evaluate the efficacy and safety of a long-acting C-peptide in subjects with type 1 diabetes and mild to moderate peripheral neuropathy.RESEARCH DESIGN AND METHODSA total of 250 patients with type 1 diabetes and peripheral neuropathy received long-acting (pegylated) C-peptide in weekly dosages of 0.8 mg (n = 71) or 2.4 mg (n = 73) or placebo (n = 106) for 52 weeks. Bilateral sural nerve conduction velocity (SNCV) and vibration perception threshold (VPT) on the great toe were measured on two occasions at baseline, at 26 weeks, and at 52 weeks. The modified Toronto Clinical Neuropathy Score (mTCNS) was used to grade the peripheral neuropathy.RESULTSPlasma C-peptide rose during the study to 1.8–2.2 nmol/L (low dose) and to 5.6–6.8 nmol/L (high dose). After 52 weeks, SNCV had increased by 1.0 ± 0.24 m/s (P < 0.001 within group) in patients receiving C-peptide (combined groups), but the corresponding value for the placebo group was 1.2 ± 0.29 m/s. Compared with basal, VPT had improved by 25% after 52 weeks of C-peptide therapy (Δ for combined C-peptide groups: −4.5 ± 1.0 μm, placebo group: −0.1 ± 0.9 μm; P < 0.001). mTCNS was unchanged during the study.CONCLUSIONSOnce-weekly subcutaneous administration of long-acting C-peptide for 52 weeks did not improve SNCV, other electrophysiological variables, or mTCNS but resulted in marked improvement of VPT compared with placebo.

100 项与 Pegylated synthetic human c-peptide 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16283

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
1型糖尿病	临床2期	加拿大	Cebix, Inc.	2012-10-01
1型糖尿病	临床2期	美国	Cebix, Inc.	2012-10-01
1型糖尿病	临床2期	瑞典	Cebix, Inc.	2012-10-01
糖尿病周围神经病变	临床2期	美国	Cebix, Inc.	2012-10-01
糖尿病周围神经病变	临床2期	瑞典	Cebix, Inc.	2012-10-01
糖尿病周围神经病变	临床2期	加拿大	Cebix, Inc.	2012-10-01

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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


NCT01681290 (Pubmed \| Diabetes Care)	临床2期	1型糖尿病	250	Long-acting C-peptide 0.8 mg	構窪夢淵夢鬱窪構鏇選(襯襯蓋膚糧蓋繭繭蓋築) = 餘窪夢齋糧齋夢衊壓艱醖淵衊構遞衊鹹範壓醖 (淵獵餘鏇夢簾鹹積膚醖 ) 更多	-	2016-04-01
				Long-acting C-peptide 2.4 mg	構窪夢淵夢鬱窪構鏇選(襯襯蓋膚糧蓋繭繭蓋築) = 廠衊網餘遞壓網窪簾繭醖淵衊構遞衊鹹範壓醖 (淵獵餘鏇夢簾鹹積膚醖 ) 更多