EUCTR2017-004098-15-EE进行中（未招募）1 期
A Randomised, Double-blind, Placebo-controlled, Phase 2 Study to Assessthe Efficacy and Safety of Orally Administered DS107 in a once daily doseof 2g in Haemodialysis Patients with Moderate to Severe Uremic Pruritus
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- DS Biopharma
- 入组人数
- 110
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. Male or female patients who are aged 18 years and older on the day of signing the informed consent form (ICF).
- •2. Patients who are on stable haemodialysis 3 times a week for at least 3 months prior to screening with a urine production of less than 300 ml per day.
- •3. Patients with continued (uncontrolled) pruritus despite standard of care in the institution.
- •4. Patients with moderate to severe pruritus, as determined by qualifying mean worst NRS score in a day of =5 (on 11 point NRS) at the screening visit.
- •5. Female patients and male patients with female partners of child bearing potential must use highly effective birth control methods or have a sterilised partner for the duration of the study. Highly effective birth control methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include systemic hormonal contraceptives, intrauterine device or sexual abstinence.
- •Note: Hormonal contraceptives must be on a stable dose for at least one month before baseline.
- •Note: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject
- •6. Patients whose pre-study clinical laboratory findings do not interfere with their participation in the study, in the opinion of the Investigator.
- •7. Patients who are able to communicate well with the Investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent.
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Patients who are known to be non-compliant with dialysis treatment
- •(i.e., has missed more than 2 dialysis sessions in the past 2 months
- •because of non-compliance).
- •2. Patients who are anticipated to receive a kidney transplant during the
- •3. Patients on peritoneal dialysis.
- •4. Patients with substantial residual renal output (>300 ml per day).
- •5. Patients with pruritus only during the dialysis session (by patient
- •6. Patients with pruritus probably or definitely attributed to a cause
- •other than end stage renal disease or its complications (e.g., patients
- •with concomitant pruritic dermatological disease or cholestatic liver
- •disease will be excluded).
- •7. Patients with a serum alanine aminotransferase (ALT) or aspartate
- •aminotransferase (AST) greater than 2.5 times the reference upper limit
- •of normal (ULN), or total bilirubin greater than 2 times ULN at screening.
- •8. Patients with a history of clinically significant drug or alcohol abuse in
- •the opinion of the investigator in the last year prior to Baseline (Day 0).
- •9. Patients using any topical agents with potential antipruritic activity,
- •excluding emollients, during the 2 weeks before the baseline visit.
- •10. Patients with systemic antipruritic treatment during the 2 weeks
- •before the baseline visit. Second and third generation oral
- •antihistamines are allowed if the patient is on stable dose of
- •antihistamine and this dose is not changed during the study period. First
- •generation oral antihistamines are disallowed.
- •11. Patients on immuno-suppressant treatment such as Cyclosporine A
- •(CsA), Methotrexate, Glucocorticoid steroids and similar compounds.
- •12. Patients who have received ultraviolet B treatment in the 4 weeks
- •prior to the start of Screening or anticipated to receive such treatment
- •during the study.
- •13. Patients who have participated in any other clinical study with an
- •investigational medicinal product (IMP) within 3 months before the first
- •day of administration of study treatment.
- •14. Patients who are pregnant, planning pregnancy, breastfeeding
- •and/or are unwilling to use adequate contraception (as specified in
- •inclusion criterion 5) during the trial.
- •15. Patients, in the opinion of the Investigator, not suitable to
- •participate in the study.
研究者
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