EUCTR2018-002575-17-PL进行中（未招募）1 期
A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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
- •- A definite or probable diagnosis of PBC (consistent with the European Association for the Study of the Liver [EASL] Practice Guidelines and the American Association for the Study of Liver Diseases; [Lindor 2009a, EASL 2017])
- •- Qualifying ALP and/or bilirubin liver biochemistry values
- •- Age =18 years
- •- Taking UDCA for at least 12 months (stable dose for =3 months) before Day 1 or unable to tolerate or unresponsive to UDCA (no UDCA for =3 months) before Day 1
- •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 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- History or presence of other concomitant liver diseases
- •- Presence of clinical complications of PBC or clinically significant (CS) hepatic decompensation at Screening Visit 1 and 2
- •- Medical conditions that may cause nonhepatic increases in ALP or which may diminish life expectancy to <2 years
- •-Presence of any other disease or condition that interferes with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the intestine
- •- Current or history of gallbladder disease with or without cholelithiasis and symptoms
- •- History of drug-induced myopathy
- •- Severe renal failure (serum creatinine >1.5 mg/100 mL (>135 µmol/L); creatinine clearance <60 mL/min) or undergoing dialysis
- •- Platelet count <100 000/ml at Screening Visits 1 and 2
- •- Known history of human immunodeficiency virus (HIV) infection
- •- History or presence of clinically concerning cardiac arrhythmias likely to affect survival during the study, or Screening (pretreatment) QT or QTc interval of >500 milliseconds
- •- Severe pruritus, or required systemic treatment for pruritus (eg, with bile acid sequestrants or rifampicin) within 2 months of Day 1
- •- History of known or suspected CS hypersensitivity to OCA, BZF, or other fibrates or any of their components
- •- Known photoallergic or phototoxic reactions to fibrates
- •- If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
- •- Other CS medical conditions that are not well controlled or for which medication needs are anticipated to change during the study (eg, type 2 diabetes mellitus, hypothyroidism, nephritic syndrome, dysproteinemia,
- •obstructive liver disease)
- •- Treatment with commercially available OCA or participated in a previous study involving OCA within 6 months before Screening
- •- Unable to tolerate BZF or other fibrates, treatment with commercially available fibrates or participation in a previous study involving fibrates within 3 months before Screening
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply
研究者
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