Cytheris announces interim results of clinical trial of IL-7 in HCV

StephenW

Cytheris Announces Interim Results from ECLIPSE 2 Hepatitis C Multicenter Study of IL-7 in Chronically Infected Genotype 1 and 4 Nonresponders to Standard of Care (SOC)
       
These results have some significance for HBV as there is also an on-going trial involving IL-7 and HBV.

Trial ID Number: CLI-107-10 Title: Phase I/IIa Randomized Open Label Controlled Dose Escalation Study of Repeated Administration of “CYT107” (glyco-r-hil-7) Added on Antiviral Treatment and Vaccination in HBeAG-Negative Chronic Hepatitis B-Infected Patients
Trial Name: CONVERT (Combination Of InterleukiN-7 and Vaccine with nEw anti-viRals in HBV Treatment)
  Countries: France,  Italy
  Status: Ongoing
  Link to Clinical Trial: Clinical  Trials.gov
About the CONVERT Study
  CONVERT is a randomized open label,  controlled multicentre Phase I inter-patient dose escalation study, followed by  a Phase IIa extension of 1 or 2 dose levels of CYT107 which have demonstrated safety  and sufficient immunological or antiviral activity.
The primary objective of the study is to  determine the short and long-term safety and biological activity of CYT107 in  patients with a HBeAg-negative chronic hepatitis B virus who have, at screening,  undetectable HBV DNA and who have been stable for at least 3 months with  antiviral treatment.
At each dose level, two treatment groups  will be run in parallel by including cohorts of 4 patients, 3 treated with  CYT107 and 1 control patient (not receiving CYT107). The two treatment groups  are characterized by the following:

• Tri-therapy group (Group 1): patients       will receive HBV vaccine (GenHevac B Pasteur®) + antiviral       treatment [BARACLUDE® (entecavir) or VIREAD® (tenofovir)]       + CYT107 and one control patient will receive only antiviral treatment       (entecavir or tenofovir)
• Bi-therapy group (Group 2): patients       will receive antiviral treatment (entecavir or tenofovir) + CYT107 and one       control patient will receive antiviral treatment (entecavir or tenofovir)       only.
  

Patients with chronic HBeAg-negative  hepatitis will be assessed for study participation if they have undetectable  HBV DNA for at least 3 months when treated with entecavir or tenofovir. The  antiviral therapy will be continued during the full duration of the study for  both groups. All included patients will be followed up to Week 48. The mid-term  evaluation of the biological activity will be performed at Week 16.

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StephenW

Cytheris公布中期业绩从Eclipse 2的IL - 7的C型肝炎慢性感染基因型1和4无应答的多中心研究的护理标准（SOC）
      
这些结果对HBV有一定的意义，也有一个持续的试验，涉及IL - 7和HBV。

审判身份证号码：CLI - 107 - 10标题：第一阶段的I /第IIa随机开放标签控制剂量“CYT107”（糖- R - HIL - 7）重复管理升级研究添加于HBeAg阴性慢性肝炎的抗病毒治疗和疫苗接种B超感染的病人
试用名称：CONVERT（白细胞介素- 7和疫苗与乙肝治疗的新的抗病毒药物的组合）
  国家：法国，​​意大利
  状态：进行中
  临床试验：临床Trials.gov
关于转换的研究
  转换是一个随机开放标签，多中心控制相我间病人的剂量递增研究，由IIa期延长1或2 CYT107显示的安全性和足够的免疫或抗病毒活性的剂量水平。
该研究的主要目的是确定一个HBeAg阴性慢性乙肝病毒，筛选，检测不到乙肝病毒DNA和谁已经稳定至少3患者的短期和长期的安全性和生物活性CYT107个月的抗病毒治疗。
每个剂量水平，两个治疗组将并行运行，其中包括4例，3 CYT107和1个控制病人（不接受CYT107）处理队列。两个治疗组具有以下特点：

    GenHevac三治疗组（1组）：患者将接受乙肝疫苗（乙巴斯德®）+抗病毒治疗[博路定®（恩替卡韦）或VIREAD ®（替诺福韦）] + CYT107和一个控制病人只能得到抗病毒治疗（恩替卡韦或替诺福韦）
    双向治疗组（2组）：患者将接受抗病毒药物治疗（恩替卡韦或替诺福韦）+ CYT107和控制病人接受抗病毒治疗（恩替卡韦或替诺福韦）。

参与研究，如果他们有至少3个月乙肝病毒DNA检测不到时，恩替卡韦或替诺福韦治疗HBeAg阴性慢性肝炎患者将评估。抗病毒药物治疗，将继续为这两个群体在整个期间的研究。所有患者随访48周。将在16周的中期评估的生物活性。

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