An Open-label Single-arm Treatment Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact for Patients With Primary Hyperoxaluria Who Completed Study OC5-DB-02
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 14
- 主要终点
- Change From Baseline in Kidney Function (eGFR) After 12 and 24 Months of Open-label Oxabact Treatment
研究概览
简要总结
Open label extension study of Oxabact OC5 in patients with primary hyperoxaluria
详细描述
OC5-OL-02 (ePHex-OLE) is a 2 year, open-label, extension study to evaluate the long-term efficacy and safety of Oxabact OC5 for patients with primary hyperoxaluria who completed treatment in the parent double-blind, placebo-controlled study OC5-DB-02 (ePHex).
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
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent (as applicable for the age of the subject).
- •Participation in and completion of study OC5-DB-
- •Subjects who had received vitamin B6 during OC5-DB-02 study should maintain a stable dose. Subjects not receiving vitamin B6 during OC5-DB-02 must be willing to refrain from initiating pyridoxine during study participation.
排除标准
- •Inability to swallow size 4 capsules.
- •Use of antibiotics to which O. formigenes is sensitive.
- •Current treatment with a separate ascorbic acid preparation.
- •Pregnant or lactating women (or women who are planning to become pregnant).
- •Women of childbearing potential who are not using adequate contraceptive precautions.
- •Presence of a medical condition that the Investigator considers likely to make the subject susceptible to adverse effect of study treatment or unable to follow study procedures or any condition that is likely to interfere with the study drug mechanism of action (such as abnormal GI function).
- •Participation in any interventional study of another investigational product, biologic, device, or other agent or not willing to forego other forms of investigational treatment during this study.
结局指标
主要结局
Change From Baseline in Kidney Function (eGFR) After 12 and 24 Months of Open-label Oxabact Treatment
时间窗: 104 weeks
Change in eGFR measured as mL/min/1.73m2. Baseline values are from the period before treatment with Oxabact. For the patients treated with Oxabact in the double-blind study, baseline is prior to treatment in that study. For patients who were treated with placebo in the double-blind study, baseline values are from the extension study, which was 48 to 52 weeks in the double-blind study.
次要结局
- Change From Baseline in Plasma Oxalate Concentration(Up to 104 weeks)