EUCTR2017-004098-15-LV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
- •3. Patients with continued (uncontrolled) pruritus despite standard of
- •care in the institution.
- •4. Patients with 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 adequate contraception or have a sterilised
- •partner for the duration of the study. Adequate contraception is defined
- •as: systemic hormonal contraceptives, intrauterine device or agree to
- •sexual abstinence. Hormonal contraceptives must be on a stable dose for
- •at least one month before baseline.
- •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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