NCT02701166Unknown3 期
The Effect of Bezafibrate on Cholestatic Itch
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)9 个研究点 分布在 2 个国家目标入组 84 人开始时间: 2016年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 84
- 试验地点
- 9
- 主要终点
- Proportion of patients with a reduction in itch intensity of 50% or more
研究概览
简要总结
Randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of primary biliary cholangitis or primary/secondary sclerosing cholangitis as defined by EASL clinical practice guidelines of cholestasis 2009;
- •itch without primary dermatologic abnormalities and with an intensity score of ≥ 5.0 cm on a scale from 0.0 cm (no itch) to 10.0 cm (worst itch possible), scored twice in the week before inclusion.
排除标准
- •Concomitant guideline-recommended as well as experimental antipruritic therapy, e.g.
- •rifampicin, opioid-receptor antagonists (naltrexon, naloxone), serotonin-reuptake inhibitors (sertraline), ondansetron, phenobarbital, propofol, lidocaine, dronabinol, butorphanol, internal or external biliary drainage, extracorporeal albumin dialysis, ultraviolet-B phototherapy; NB. Topical menthol containing agents are allowed, as well as bile salt sequestrants (colesevelam, cholestyramin) as long as taken at least 4 hours before or after intake of the study medication. Incidental use of these agents should be noted by patients in the diary, structural use should be noted on the CRF (section co-medication);
- •Pregnancy, women of childbearing potential not using contraception, breast feeding;
- •Cholestasis due to obstruction that requires invasive desobstructive treatment within the time scope of the study (5 weeks), such as endoscopic retrograde cholangiopancreaticography (ERCP) or surgical removal of a tumor compressing the bile duct;
- •Use of opiates;
- •Renal insufficiency (creatinine clearance <60mL/min).
研究组 & 干预措施
Bezafibrate
Experimental
Bezalip retard 400mg tablet
干预措施: Bezafibrate (Drug)
Placebo
Placebo Comparator
Placebo 400mg tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of patients with a reduction in itch intensity of 50% or more
时间窗: 3 weeks
次要结局
- Serum creatinin kinase(3 weeks)
- Serum cholesterol(3 weeks)
- Serum autotaxin activity(3 weeks)
- Serum liver tests(3 weeks)
- Serum creatinine(3 weeks)
研究者
Ruth Bolier
prof. dr. Ulrich Beuers
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (9)
Loading locations...
相似试验
已完成
2 期
The effect of bezafibrate on cholestatic itchprimary biliary cirrhosis10019654primary sclerosing cholangitisNL-OMON42182Academisch Medisch Centrum52
进行中（未招募）
1 期
The effect of bezafibrate on itch in a subset of liver diseasesPrimary biliary cirrhosis (PBC) Primary sclerosing cholangitis (PSC) Secondary sclerosing cholangitis (SSC)EUCTR2014-001438-27-ESAcademic Medical Center84
进行中（未招募）
不适用
The effect of bezafibrate on itch in a subset of liver diseasesPrimary biliary cirrhosis (PBC)Primary sclerosing cholangitis (PSC)Secondary sclerosing cholangitis (SSC)EUCTR2014-001438-27-NLAcademic Medical Center84
招募中
不适用
The effect of bezafibrate on itch in liver diseasePrimary biliary cirrhosis (PBC)Primary sclerosing cholangitis (PSC)Secondary sclerosing cholangitis (SSC)NL-OMON22138Academic Medical Center, Amsterdam84
招募中
3 期
Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid TherapyCholestasisPrimary Sclerosing CholangitisNCT04309773Assistance Publique - Hôpitaux de Paris104