EUCTR2018-003576-12-BE进行中（未招募）1 期
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 - ePHex OLE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent (as applicable for the age of the subject).
- •2. Participation in and completion of study OC5-DB-02.
- •3. Subjects who had received vitamin B6 during OC5-DB-02 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 4
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •4. Inability to swallow size 4 capsules.
- •5. Use of antibiotics to which O. formigenes is sensitive.
- •6. Current treatment with a separate ascorbic acid preparation.
- •7. Pregnant women (or women who are planning to become pregnant).
- •8. Women of childbearing potential who are not using adequate contraceptive precautions.
- •9. 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).
- •10. 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.
研究者
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