ISRCTN63711065已完成2 期
A phase II/III, double-blind, randomised, placebo-controlled, multicentre study to evaluate the efficacy and safety of Oxabact™ to reduce urinary oxalate in subjects with primary hyperoxaluria
OxThera IP AB (Sweden)0 个研究点目标入组 35 人开始时间: 2010年1月22日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
研究概览
简要总结
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/28718073 [added 20/02/2019]
研究设计
- 研究类型
- Interventional
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 greater than or equal to 2 years of age
- •3. A mean urinary oxalate excretion of greater than 1.0 mmol/1.73 m2/day from eligible urine collections performed during screening
- •4. A diagnosis of PH I or PH II by one of the following:
- •4.1. Liver biopsy confirmation of deficient liver specific peroxisomal alanine-glyoxylate aminotransferase (AGT) or mislocalisation of AGT from peroxisomes to mitochondria (PH I) or deficient glyoxylate reductase/hydroxypyruvate reductase (GRHPR) activity (PH II)
- •4.2. Homozygosity or compound heterozygosity for a known mutation in the causative genes for PH I and PH II
- •4.3. Increased glycolate excretion for PH I or increased L-glycerate excretion for PH II
- •5. Subjects receiving pyridoxine must be receiving a stable dose for at least 3 months prior to entry into 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 glomerular filtration rate (GFR) greater than or equal to 40 ml/min normalised to 1.73 m2 body surface area, or a creatinine clearance of greater than or equal to 40 ml/min normalised to 1.73 m2 body surface area
排除标准
- •1. Inability to collect two complete 24-hour urine samples
- •2. Subjects diagnosed as PH I who are pyridoxine naive
- •3. Subjects that have undergone transplantation (solid organ or bone marrow)
- •4. The existence of secondary hyperoxaluria, e.g. chronic gastrointestinal diseases such as cystic fibrosis, chronic inflammatory bowel disease and short-bowel syndrome
- •5. Current systemic (oral, intramuscular [IM], intravenous [IV]) antibiotic use or received systemic antibiotics within 14 days of study enrolment
- •6. History of a recurrent infection requiring greater than two courses of systemic antibiotics in the past 6 months, or chronic antimicrobial suppression
- •7. Subjects who require immune suppressive therapy (including prednisone greater than 10 mg daily for more than 2 weeks)
- •8. Current treatment with a separate ascorbic acid preparation. Ascorbic acid up to 250 mg/day as a component of a multivitamin formulation is not excluded.
- •9. Known hypersensitivity to esomeprazol (or any of the other ingredients of this medicine), or to any other proton pump inhibitor medicine (Nexium® contraindication)
- •10. Concomitant treatment with atazanavir (Nexium® contraindication)
- •11. Pregnancy
- •12. Women of child-bearing potential who are not using adequate contraceptive precautions. Sexually active females, unless surgically sterile or at least 2 years post-menopausal, must be using a highly effective contraception (including oral, transdermal, injectable, or implanted contraceptives, intrauterine devide (IUD), abstinence, use of a condom by the sexual partner or sterile sexual partner) for 30 days prior to the first dose of Oxabact™ and must agree to continue using such precautions during the clinical study.
- •13. 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. Note: Subjects from correctional facilities or asylums and subjects who are mentally handicapped are not to be included in the study.
- •14. Participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to randomisation or not willing to forego other forms of investigational treatment during this study
研究者
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