NCT06247735已完成2 期
A Phase 2, Randomized, Placebo-controlled, Parallel Group, Multicenter 12-week Study With a 52-week Extension to Evaluate the Efficacy and Safety of Two Doses of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Inadequate Response to Ursodeoxycholic Acid and/or Obeticholic Acid Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 75
- 主要终点
- Percent change from baseline in serum alkaline phosphatase (ALP)
研究概览
简要总结
Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.
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
- •Male or female participant who has a PBC diagnosis as demonstrated by the presence of ≥2 of the following three diagnostic criteria:
- •History of ALP above ULN for at least 6 months
- •History of positive antimitochondrial antibody (AMA) titer or positive PBC-specific antinuclear antibody (ANA) titer
- •Historical liver biopsy consistent with PBC
- •Participant has the following qualifying biochemistry value at Screening:
- •ALP ≥1.5 × ULN
- •Participant is ≥18 years of age at consent.
- •Participant meets all other eligibility criteria outlined in the Clinical Study Protocol.
排除标准
- •Participant meets any one of the following criteria at Screening:
- •ALP>10 × ULN
- •ALT or AST >5 × ULN
- •Hepatitis C treatment within 5 years of Screening, or active hepatitis C as defined by positive hepatitis C antibody with the presence of hepatitis C virus ribonucleic acid; subjects with active hepatitis B (HBV) infection (hepatitis B surface antigen [HbsAg] positive) will be excluded. A subject with resolved hepatitis A at least 3 months prior to the Screening Visit can be screened.
- •Primary sclerosing cholangitis and secondary sclerosing cholangitis (eg, due to cholangiolithiasis, ischemia, telangiectasia, vasculitis, infectious diseases)
- •Alcoholic liver disease
- •History of definite autoimmune hepatitis or PBC/autoimmune hepatitis overlap, defined as both of the following: 1) IgG >2 × ULN and/or positive anti-smooth muscle antibodies, 2) liver histology revealing moderate or severe periportal or periseptal inflammation
- •Nonalcoholic steatohepatitis (NASH)
- •Gilbert's Syndrome
- •Alpha-1-antitrypsin deficiency, cystic fibrosis, Wilson's disease, hemochromatosis based on historically established diagnosis
- •Drug-induced liver injury (DILI) as defined by typical exposure and history
- •Known condition that involves bile duct obstruction or cholestasis other than PBC, eg, vascular diseases (eg, Budd-Chiari syndrome, sinusoidal obstruction syndrome, congestive hepatopathy), congenital conditions (ductal plate malformations, Caroli syndrome, congenital liver fibrosis), idiopathic ductopenia
- •Hepatocellular carcinoma
- •Participant meets any other exclusion criteria outlined in the Clinical Study Protocol.
研究组 & 干预措施
K-808 Group B
Experimental
K-808 (Dose B) for 64 Weeks
干预措施: K-808 (Dose B) (Drug)
K-808 Group A
Experimental
K-808 (Dose A) for 64 Weeks
干预措施: K-808 (Dose A) (Drug)
结局指标
主要结局
Percent change from baseline in serum alkaline phosphatase (ALP)
时间窗: Baseline to Week 12
Two doses of K-808 compared to placebo after 12 weeks of treatment
次要结局
- Achievement of normalization of ALP level(Baseline to Week 12)
- Achievement of target levels of ALP and total bilirubin (TB)(Baseline to Weeks 12 and 64)
- Change from baseline in UK-PBC score(Baseline to Weeks 12 and 64)
- Incidence of Treatment Emergent Adverse Events (TEAEs)(Baseline to Week 68)
- Change from baseline in liver function parameters(Baseline to Weeks 12 and 64)
- Change from baseline in GLOBE risk score(Baseline to Weeks 12 and 64)
研究者
研究点 (75)
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