EUCTR2012-005606-22-DE进行中（未招募）1 期
A Phase 1/2, randomised, placebo-controlled, double-blind, multi-centre study to evaluate the efficacy and safety of OC5 to reduce urinary oxalate in subjects with primary hyperoxaluria - Phase 1/2 Oxabact OC5 study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- OxThera AB
- 入组人数
- 24
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.Male or female subjects = 2 years of age.
- •3.A diagnosis of PH type I, II or III (as determined by standard diagnostic methods).
- •4.A mean urinary oxalate excretion of = 1.0 mmol/24h/1.73m2 based on at least three eligible urine collections performed during baseline (weeks 1-4).
- •5.Renal function defined as an estimated GFR = 40 ml/min normalised to 1.73m2 body surface area, or a creatinine clearance of = 40 ml/min normalised to 1.73m2 body surface area.
- •6.Subjects receiving vitamin B6 must be receiving a stable dose for at least 3 months prior to screening and must not change the dose during the study. Subjects not receiving vitamin B6 at study entry 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: 16
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Inability to collect complete 24-hour urine samples. Each urine collection will be evaluated for completeness based on the urine qualitative criteria.
- •2.Inability to swallow size 4 capsules twice daily for 8 to 10 weeks.
- •3.Subjects that have undergone transplantation (solid organ or bone marrow).
- •4.The existence of secondary hyperoxaluria, e.g. hyperoxaluria due to bariatric surgery or chronic gastrointestinal diseases such as cystic fibrosis, chronic inflammatory bowel disease and short-bowel syndrome.
- •5.Use of antibiotics to which O. formigenes is sensitive, including chronic use, a history of more than two courses of antibiotic use during the past 6 months, current antibiotic use, or antibiotic use within 14 days of initiating study medication.
- •6.Subjects who require immune suppressive therapy.
- •7.Current treatment with ascorbic acid preparation.
- •8.Pregnancy
- •9.Women of child-bearing potential who are not using adequate contraceptive precautions, such as oral, transdermal, injectable, or implanted contraceptives, IUD, complete abstinence, use of a condom by the sexual partner, or sterile sexual partner
- •10.Presence of a medical condition that the Principal Investigator considers likely to make the subject susceptible to adverse effect of study treatment or unable to follow study procedures.
- •11.Participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to screening or not willing to forego other forms of investigational treatment during this study.
研究者
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Early stage clinical trial to investigate whether the Oxabact OC5 product reduces oxalate levels in the urine of patients with primary hyperoxaluria (a disease affecting the kidneys).Primary Hyperoxaluria (PH)MedDRA version: 17.0Level: PTClassification code 10020703Term: HyperoxaluriaSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2012-005606-22-GBOxThera AB24
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