2023-504660-41-00招募中2 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (VANTAGE)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 37
- 主要终点
- Mean change in Adult ItchRO score comparing baseline with the average of the weekly averaged daily itch scores to the end of the double-blind study treatment.
研究概览
简要总结
To evaluate the efficacy of volixibat versus placebo for the treatment of pruritus in participants with PBC as measured by the change in the Adult ItchRO tool in participants with PBC
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study.
- •Male or female, age ≥18 years at the screening visit
- •Confirmed diagnosis of PBC in line with the AASLD guidelines.
- •UDCA and anti-pruritic medication use will be allowed if meeting additional criteria.
- •Qualified pruritus associated with PBC as assessed by Adult ItchRO.
排除标准
- •Chronic pruritus of other etiology that may interfere with the severity assessment of PBC-related pruritus
- •2.Evidence of decompensated cirrhosis or complications of cirrhosis (e.g., variceal bleeding or untreated esophageal/gastric varices, ascites, hepatic encephalopathy, hepatorenal syndrome).
- •Current symptomatic cholelithiasis or inflammatory gallbladder disease.
- •History of small bowel surgery/resection impacting the terminal ileum that may disrupt the enterohepatic circulation.
- •Evidence, history, or suspicion of other liver diseases.
结局指标
主要结局
Mean change in Adult ItchRO score comparing baseline with the average of the weekly averaged daily itch scores to the end of the double-blind study treatment.
Mean change in Adult ItchRO score comparing baseline with the average of the weekly averaged daily itch scores to the end of the double-blind study treatment.
次要结局
- 3. Mean change in ALP levels
- 1. Mean change in sBA levels
- 2. Mean change in total bilirubin levels
- 4.Change in Primary Biliary Cholangitis Quality of Life Measure (PBC-40) from baseline through end of double blind study treatment
- 5. Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) fatigue score from baseline to end of double blind study treatment
- 6. Change in PROMIS sleep score from baseline to end of double blind study treatment
- 7. Proportion of participants achieving a reduction of ≥ 2 points in the weekly averaged daily Adult ItchRO score from baseline to end of double blind study treatment
- 8. Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), ECIs, and AEs that lead to discontinuation of study drug
- 9. Incidence of clinically relevant laboratory abnormalities
研究者
Mirum Clinical Lead
Scientific
Mirum Pharmaceuticals Inc.
研究点 (37)
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