EUCTR2006-001185-17-GB进行中（未招募）不适用
A long-term, open-label continuation study to assess the safety of Alpharen™ in haemodialysis subjects with hyperphosphataemia. - ALCO
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
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. Taken at least one dose of double-blind medication during study IH 001 and either completed study IH 001 or were withdrawn due to reasons other than an AE considered related to study treatment.
- •2. Male or female subjects on active haemodialysis, aged 18 years or over
- •3. Written informed consent given
- •4. Willing to abstain from taking any phosphate binder or oral magnesium- or aluminium-containing products and preparations, other than the study medication
- •5. Willing to avoid any intentional changes in diet such as fasting, dieting or overeating
- •6. Willing to maintain their usual type and dose of Vitamin D supplementation.
- •Are the trial subjects under 18? no
- •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. Participation in any other clinical trial using an investigational product or device within the previous 4 months, except study IH 001;
- •2. A significant history of alcohol, drug or solvent abuse in the opinion of the investigator;
- •3. Any disease or condition, physical or psychological, which in the opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn;
- •4. Clinically significant laboratory findings (for this subject population) in the opinion of the investigator.
- •5. Any malignancy requiring treatment within 5 years of screening with the exception of basal cell carcinoma and Bowen’s disease;
- •6. A history of a motility disorder of the intestines, including, but not limited to, gastroparesis, ileus, pseudo-obstruction, megacolon, or mechanical obstruction;
- •7. A significant illness in the 4 weeks before screening;
- •8. Taking medication prescribed for seizures;
- •9. A history of haemochromatosis;
- •10. A history of serum ferritin concentration of >= 1000 ng/mL (excluding transient, treatment-induced ferritin elevation);
- •11. A history of dysphagia or swallowing disorders that might limit the subject’s ability to swallow study medication in the opinion of the investigator;
- •12. Female subjects who are lactating or pregnant. Women of childbearing potential (pre-menopausal and not surgically sterilised) unless they are using a reliable contraceptive method, that is, barrier methods, hormones or intrauterine device;
- •13. Current haemoglobin concentration of < 10.00 g/dL;
- •14. Allergy to the IMP or its constituents.
研究者
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