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
- 状态
- 已完成
- 发起方
- Cytheris SA
- 入组人数
- 10
- 试验地点
- 7
- 主要终点
- Safety of biologically active doses of CYT107 added to a standard bi-therapy in patients with a chronic infection by a genotype 1 Hepatitis C Virus (HCV) not responding to this combination therapy 12 weeks after its initiation.
研究概览
简要总结
This study will evaluate the safety of a new experimental drug, IL-7, in people with HCV infection resistant after 12 weeks of bi-therapy.
详细描述
This is a Phase I inter-patient dose-escalation study assessing weekly doses of Interleukin-7 (CYT107) in adult patients infected by Genotype 1 Virus of Hepatitis C and resistant to standard treatment with Peg-Interferon and Ribavirin (biotherapy)after 12 weeks of this standard 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 a subcutaneous administration of CYT107 per week for a total of 4 administrations.
Groups of 3 to 6 patients will be entered at each dose level of CYT107. Four dose levels are planned.
Eligible patients will a cycle of four weekly injections at a defined dose level in addition to the bi-therapy. Standard bi-therapy will continue 4 weeks after CYT107 treatment discontinuation. The duration of study is approximately 11 weeks including screening period.
Participants have 1 hospitalization overnight and 8 clinic visits. The four administrations are sub-cutaneous and are given as a shot under the skin in the arm or abdomen or leg.
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
- •Genotype I infected patients
- •Age > 18 years
- •Absence of early viral response to a first treatment with PEG-interferon-alpha plus ribavirin given for at least 12 weeks. Absence of early viral response (EVR) will be defined as detectable HCV with a decrease HCV RNA load < 2 logs, measured by a quantitative PCR tests, as compared to baseline levels measured by a similar technique
- •Ongoing treatment by PEG-interferon-alpha plus ribavirin at study entry
排除标准
- •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
- •Cirrhosis (Metavir F4) assessed by biopsy or FibroScan® or by liver biopsy within the last 6 months prior CYT107 treatment initiation. If assessed by Fibroscan® patients with a result > 10 KPa will be excluded
- •Other liver disease (notably from alcoholic, metabolic or immunological origin)
- •Body mass index (BMI) > 30kg/m2
- •Inability to give informed consent
- •Administration of growth factors (G-CSF, EPO) within the 12 weeks of the combination therapy
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 standard bi-therapy in patients with a chronic infection by a genotype 1 Hepatitis C Virus (HCV) not responding to this combination therapy 12 weeks after its initiation.
时间窗: 8 weeks after start of CYT107
次要结局
- Pharmacokinetics and pharmacodynamics of CYT107 in this patients population.(As primary)
- potential anti-viral effect of CYT107(As primary)
- immune specific response to HCV(As primary)