EUCTR2014-005012-42-EE进行中（未招募）1 期
A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with Obeticholic Acid in Liver Treatment (COBALT)
Intercept Pharmaceuticals Inc.0 个研究点目标入组 428 人开始时间: 2015年10月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 428
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. Definite or probable PBC diagnosis (consistent with American
- •Association for the Study of Liver Diseases [AASLD] and the European
- •Association for the Study of the Liver [EASL] practice guidelines; Lindor
- •2009; EASL 2009), as demonstrated by the presence of =2 of the
- •following 3 diagnostic factors:
- •a. History of elevated ALP levels for at least 6 months
- •b. Positive antimitochondrial antibody (AMA) titer or if AMA
- •negative or in 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])
- •c. Liver biopsy consistent with PBC
- •2. A mean total bilirubin >ULN and =5x ULN and/or a mean ALP >3x ULN
- •3. Age =18 years
- •4. Either is not taking UDCA (no UDCA dose in the past =3 months) or
- •has been taking UDCA for at least 12 months with a stable dose for =3
- •months prior to Day 0
- •5. Contraception: Female subjects must be postmenopausal, surgically
- •sterile, or, if premenopausal (and not surgically sterile), be prepared to
- •use =1 highly effective method of contraception during the study and for
- •30 days after the end of treatment. Highly effective methods of
- •contraception per the CTFG guidelines are those that alone or in
- •combination results in a failure rate of less than 1% per year when used
- •consistently and correctly. Highly effective methods of contraception are
- •as follows:
- •Intrauterine device
- •- Intrauterine device (IUD)
- •- Intrauterine hormone-releasing system (IUS)
- •Bilateral tubal occlusion
- •Vasectomy (partner)
- •Combined (estrogen and progestogen containing) hormonal
- •contraception (eg, oral, intravaginal or transdermal) associated with
- •inhibition of ovulation. If oral contraceptives are used, they must be
- •used in combination with a male or female condom. Female subjects
- •should have been on the hormone contraception for at least 8 days prior
- •Progestogen-only hormonal contraception (eg oral, injectable or
- •implantable) associated with inhibition of ovulation. If oral
- •contraceptives are used, they must be used in combination with a male
- •or female condom. Female subjects should have been on the hormone
- •contraception for at
- •least 8 days prior to Day 1.
- •Sexual abstinence, if in line with the preferred and usual lifestyle of
- •the subject (where abstinence is defined as refraining from heterosexual
- •intercourse during the entire period of risk associated with study
- •treatments).
- •6. Must provide written informed consent and agree to comply with the
- •study protocol
- •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 278
- 另有 2 项未显示
排除标准
- •1. History or presence of other concomitant liver diseases including:
- •a. Hepatitis C virus infection
- •b. Active hepatitis B infection; however, subjects 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
- •c. Primary sclerosing cholangitis
- •d. Alcoholic liver disease
- •e. Definite autoimmune liver disease or overlap hepatitis
- •f. Nonalcoholic steatohepatitis
- •g. Gilbert's Syndrome
- •2. Presence of clinical complications of PBC or clinically significant
- •hepatic decompensation, including:
- •a. History of liver transplant, current placement on a liver transplant
- •list, or current MELD score >12. Subjects who are placed on a transplant
- •list despite a relatively early disease stage (for example per regional
- •guidelines) may be eligible as long as they do not meet any of the other
- •exclusion criteria
- •b. Cirrhosis with complications, including history (within the past 12
- •months) or presence of:
- •i. Variceal bleeding
- •ii. Uncontrolled ascites
- •iii. Encephalopathy
- •iv. Spontaneous bacterial peritonitis
- •c. Known or suspected hepatocellular carcinoma
- •d. Prior transjugular intrahepatic portosystemic shunt procedure
- •e. Hepatorenal syndrome (type I or II) or Screening (visit 1 or 2)
- •serum creatinine >2 mg/dL (178 µmol/L)
- •3. Mean total bilirubin >5× ULN
- •4. Subjects who have undergone gastric bypass procedures (gastric lap
- •band is acceptable) or ileal resection or plan to undergo either of these
- •5. Other medical conditions that may diminish life expectancy, including
- •known cancers (except carcinomas in situ or other stable)
- •6. If female: plans to become pregnant, known pregnancy or a positive
- •urine pregnancy test (confirmed by a positive serum pregnancy test), or
- •7. Known history of human immunodeficiency virus infection
- •8. Medical conditions that may cause nonhepatic increases in ALP (eg,
- •Paget's disease or fractures within 3 months prior do Day 0)
- •9. Other clinically significant medical conditions that are not well
- •controlled or for which medication needs are anticipated to change
- •during the study
- •10. History of alcohol abuse or other substance abuse within 1 year prior
- •11. Participation in another investigational product, biologic, or medical
- •device study within 30 days prior to Screening. Participation in a
- •previous study of OCA is allowed with 3 months washout prior to
- •enrollment in this study
- •12. Mental instability or incompetence, such that the validity of informed
- •consent or ability to be compliant with the study is uncertain
- •13. History of known or suspected clinically significant hypersensitivity
- •to OCA or any of its components
- 另有 1 项未显示
研究者
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