JPRN-jRCT2071230106招募中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
Tanigawa Ryohei0 个研究点目标入组 45 人开始时间: 2024年1月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
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; participant with active hepatitis B (HBV) infection (hepatitis B surface antigen [HbsAg] positive) will be excluded. A participant 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-smoothmuscle antibodies and 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 confirmed 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.
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