A Phase I/IIa Dose Escalation Study in Asia of Repeated Administration of "CYT107" (Glyco-r-hIL-7) Added on Treatment in Genotype 1 HCV Infected Patients Resistant to Pegylated Interferon-alpha and Ribavirin
试验速览
- 阶段
- 1 期
- 发起方
- Cytheris SA
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- safety of biologically active doses of CYT107 added to a combination therapy by pegylated interferon-alpha and ribavirin in Asian patients with a chronic infection by a genotype 1 HCV not responding to this combination therapy
研究概览
简要总结
This study is designed to evaluate the safety of biological active dose of a new experimental drug, IL-7, in combination with standard bi-therapy in Asiatic patients with Hepatitis C chronic infection identified as non responders to the standard bi-therapy alone.
详细描述
This is a Phase I/IIa inter-patient dose-escalation study assessing weekly doses of Interleukin-7 (CYT107) in Asiatic adult patients infected by virus of genotype 1 of Hepatitis C and resistant to standard treatment with Peg-Interferon and Ribavirin (bi-therapy).
The dose escalation is aimed at establishing the safety of a biologically active doses of CYT107 added to the combination therapy of pegylated interferon-alpha and ribavirin. At each dose level, study patients will receive one subcutaneous administration of CYT107 per week for a total of 4.
Groups of 3 to 6 patients will be entered at each dose level of CYT107. Three dose levels are planned.
Eligible patients initially receive bi-therapy for 6-10 weeks. Thereafter, CYT107 is added for a cycle of four weekly injections at a defined dose level while standard bi-therapy continues for 9 weeks after CYT107 treatment discontinuation. The patients are then followed on a regular basis until reaching 48 weeks after the CYT107 treatment. The duration of study is approximatively 60 weeks with 20-25 weeks of bi-therapy.
Participants will have 1 overnight hospitalization and 15 clinic visit on a period of 60 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV Genotype 1 infected patients
- •Absence of viral response to previous treatments with pegylated interferon-alpha plus ribavirin
- •Metavir ≤ F3 assessed by biopsy in the last 12 months
排除标准
- •Active infection by HBV
- •Infection by HIV-1 and /or HIV-2
- •Apart from HCV infection, presence of active infection requiring a specific treatment or a hospitalization
- •Other liver disease
- •Body mass index (BMI) > 30kg/m2
- •Relapse after previous response to pegylated IFN alpha and ribavirin therapy
- •Previous bi-therapy with pegylated IFN alpha and ribavirin not well tolerated (in particular treatment discontinuation)
- •Any history of malignancy apart from curatively treated basal cell carcinoma or in situ cervical carcinoma
- •History of clinical autoimmune disease or active auto-immune disease
- •History of severe asthma, presently on chronic medications
- •Significant cardiac or pulmonary disease
- •Inability to give informed consent
研究组 & 干预措施
CYT107
干预措施: Interleukin-7 (Drug)
结局指标
主要结局
safety of biologically active doses of CYT107 added to a combination therapy by pegylated interferon-alpha and ribavirin in Asian patients with a chronic infection by a genotype 1 HCV not responding to this combination therapy
时间窗: 12 weeks after start of CYT107
次要结局
- Pharmacokinetics and pharmacodynamics of CYT107 in this patients population.(At short and mid terms follow-ups)
- potential anti-viral effect of CYT107(4 weeks and 12 weeks after start of CYT107)
- long-term safety and viral load variations(24 and 48 weeks after the start of CYT107)
- immune specific response to HCV(8 and 12 weeks after start of CYT107)