A Phase 2a, Pilot, Open-Label Trial Evaluating the Safety, Tolerability and Pharmacodynamic Effects of GS-6624 in Subjects With Fibrosis of the Liver
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of adverse events on multiple, escalating IV doses of simtuzumab
研究概览
简要总结
This study will evaluate the safety and tolerability of simtuzumab (GS-6624) in patients with fibrosis of the liver.
Up to 20 participants will be enrolled into two sequential cohorts. Cohort 1 will consist of 10 participants who will receive simtuzumab every other week for a total of 3 infusions. Participants in Cohort 2 (10 subjects) will also receive simtuzumab every other week for a total of 3 infusions; the dose will depend on the safety and tolerability of simtuzumab seen in Cohort 1.
Participants from both cohorts who have completed the main study will be allowed to continue on simtuzumab treatment for an additional extension period, and will receive up to 13 additional infusions of simtuzumab at a fixed dose of 700 mg for an additional 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females 18 - 65 years of age
- •Chronic liver disease of any etiology
- •Stage 1-3 fibrosis by Metavir score on a liver biopsy.
- •Body mass index <36 kg/m2
排除标准
- •Any evidence of hepatic decompensation past or present
- •Subjects currently abusing amphetamines, cocaine, opiates, or alcohol
- •Clinically significant cardiac disease
- •History of cancer, other than non-melanomatous skin cancer, within 5 years prior to Screening
- •Systemic fungal, bacterial, viral, or other infection that is not controlled
- •Use of systemic immunosuppressants within 28 days of the Pre-treatment Phase
- •Use of approved therapy for hepatitis C or hepatitis B virus within 28 days of the Pre-treatment Phase
- •Pregnant or lactating
- •History of bleeding diathesis within the last 6 months of study Day 1
结局指标
主要结局
Incidence of adverse events on multiple, escalating IV doses of simtuzumab
时间窗: Through Week 14
The endpoints to be evaluated will include graded Adverse Events, laboratory abnormalities, and vital sign measurements
次要结局
- Assessment of serum concentration of simtuzumab(Through Week 14)
- Antibody formation to simtuzumab (anti-simtuzumab Abs)(Through Week 14)
- Measurement of pharmacodynamic (PD) markers after administration of simtuzumab(Through Week 14)
- Assessing the effects of chronic dosing of simtuzumab on liver structure and fibrotic markers(Up to 24 weeks)