EUCTR2017-001762-13-DE进行中（未招募）1 期
A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients with Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •1. A definite or probable diagnosis of PBC (consistent with American Association for the Study of Liver Diseases [AASLD] and European Association for the Study of the Liver [EASL] Practice Guidelines, defined as having =2 of the following 3 diagnostic factors:
- •History of elevated ALP levels for at least 6 months
- •Positive antimitochondrial antibody (AMA) titer or if AMA negative or low titer (=1:80), PBC specific antibodies (anti-GP210 and/or anti-SP100) and/or antibodies against the major M2 components (PDC E2, 2-oxo-glutaric acid dehydrogenase complex)
- •Liver biopsy consistent with PBC (collected at any time prior to Screening)
- •2. Evidence of cirrhosis including at least one of the following:
- •Biopsy results consistent with PBC Stage 4
- •Liver stiffness as assessed by TE Value =16.9kPa
- •Clinical evidence in the absence of acute liver failure consistent with cirrhosis including: gastroesophageal varices, ascites, radiological evidence of cirrhosis (nodular liver or enlargement of portal vein and splenomegaly)
- •Combined low platelet count (<140 000/mm3) with
- •- persistent decrease in serum albumin, or
- •- elevation in prothrombin time/INR (not due to antithrombotic agent use), or
- •- elevated bilirubin (2× ULN)
- •3. Satisfy the criteria of the modified CP classification for hepatic impairment during Screening:
- •Moderate: CP-B (Scores 7 to 9) or
- •Severe: CP-C (Scores 10 to12)
- •4. MELD score of 6 to 24 at Screening
- •5. Taking UDCA for at least 12 months (stable dose for =3 months) prior to Day 1, or unable to tolerate or unresponsive to UDCA (no UDCA for =3 months)
- •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 31
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 19
排除标准
- •1. Non-cirrhotic or cirrhotic CP-A (Mild; Score 5 to 6)
- •2. History of liver transplant or organ transplant
- •3. History of alcohol or drug abuse within 12 months prior to Screening
- •4. Current hepatic encephalopathy (as defined by a West Haven score of =2)
- •5. History or presence of other concomitant liver diseases including:
- •Hepatitis C virus infection and RNA positive
- •Active hepatitis B infection; however, patients who have seroconverted (hepatitis B surface antigen and hepatitis B e antigen negative) may be included in this study after consultation with the Medical Monitor
- •Primary sclerosing cholangitis
- •Alcoholic liver disease
- •Definite autoimmune liver disease or overlap hepatitis
- •Gilbert’s Syndrome
- •6. In the opinion of the Investigator, fluctuating or rapidly deteriorating hepatic function prior to randomization
研究者
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