EUCTR2007-002328-14-NL进行中（未招募）不适用
A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multi-center, International Study to Evaluate the Efficacy and Safety of Oxabact(TM) to Reduce Urinary Oxalate in Subjects with Primary Hyperoxaluria. - Study to see if Oxabact reduces urinary oxalate, the Phoenix study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- OxThera Inc.
- 入组人数
- 42
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. The subject (or legally acceptable representative) must give written informed consent (and assent for subjects = 12 years or country specific age as appropriate). For subjects less than 18 years of age, parent or guardian will provide informed consent and the subject will provide witnessed verbal assent
- •2. Male or female subjects greater than or equal to 5 years of age
- •3. Urinary oxalate excretion of > 1.0 mmol/1.73m2/day at Baseline
- •4. Documentation of diagnosis of PH I or PH II by any one of the following:
- •a. Liver biopsy confirmation of deficient liver specific peroxisomal alanine-glyoxylate aminotransferase, (AGT) or mislocalization of AGT from peroxisomes to mitochondria (PH I) or deficient glyoxylate reductase/hydroxypyruvate reductase (GR/HPR) activity (PH II)
- •b. Homozygosity or compound heterozygosity for a known mutation in the causative genes for PH I and PH II
- •c. Increased glycolate excretion for PH I or increased L-glycerate excretion for PH II
- •d. Family history in a sibling with a definitive diagnosis of PH
- •5. Subjects receiving pyridoxine must be receiving a stable dose for at least 3 months prior to entry in to the study and must remain on the stable dose during the study. Subjects not receiving pyridoxine at study entry must be willing to refrain from initiating pyridoxine during study participation.
- •6. Renal function defined as an estimated GFR = 50 ml/min normalized to 1.73m2 body surface area
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions. Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must be using a medically acceptable method of contraception (including oral, transdermal, injectable, or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 30 days prior to the first dose of OxabactTM and must agree to continue using such precautions during the clinical study.
- •2. Positive serum pregnancy test
- •3. Participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to randomization or not willing to forego other forms of investigational treatment during this study
- •4. Subjects on hemodialysis or peritoneal dialysis
- •5. Subjects that have undergone transplantation (solid organ or bone marrow)
- •6. Chronic gastrointestinal disease associated with enteric hyperoxaluria, e.g., history of inflammatory bowel disease, colostomy
- •7. Current systemic (oral, IM, IV) antibiotic use or received systemic antibiotics within 14 days of study enrolment
- •8. History of chronic, recurrent infections requiring >2 courses of antibiotics in the past 6 months
- •9. History of malignancy except for basal or squamous cell skin cancer that has been excised
- •10. Unable to collect 24-hour urine samples or follow other study procedures
- •11. Subjects who cannot swallow a size 2 capsule
- •12. 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
- •13. Subjects who require immune suppressive therapy (including prednisone of > 10mg daily for more than 2 weeks).
研究者
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