ISRCTN22662520已完成未知
A pilot study to evaluate the safety, tolerability and efficacy of obeticholic acid (INT-747) for the treatment of portal hypertension
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 34
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
- 性别
- All
入选标准
- •1. Male or female age 18-70 years
- •2. History of alcoholic cirrhosis with clinical or radiological and biochemical evidence of cirrhosis
- •3. Evidence of early decompensated cirrhosis (Child-Pugh score =7 to =12)
- •4. Patients recruited into the cohort evaluation of efficacy must have significant portal hypertension defined as an HVPG = 12 mmHg
- •5. Patients with large or grade 3 oesophageal varices as identified by endoscopy within 6 months of screening should be in an endoscopic band ligation program at the time of study entry
- •6. Female patients must be postmenopausal, surgically sterile, or if premenopausal, must be prepared to use at least one effective (=1% failure rate) method of contraception during the course of the study and for 14 days after the end of dosing. Male patients with female partners of child bearing potential must be prepared to use at least one effective method of contraception with all sexual partners unless they have had a prior vasectomy. Effective methods of contraception are considered to be:
- •6.1. Condom (male or female)
- •6.2. Diaphragm, with spermicide
- •6.3. Hormonal (e.g. contraceptive pill, patch, intramuscular implant or injection)
- •6.4. Intrauterine device (IUD)
- •6.5. Vasectomy (partner)
- •7. Must be willing and able to give written informed consent and agree to comply with the study protocol
排除标准
- •1. Patients with co-existing disease including:
- •1.1. Significant organ failure defined as:
- •1.2. Respiratory: PaO2 < 8kPa
- •1.3. Renal: serum creatinine >150 µmol/L
- •1.4. Cardiovascular: haemodynamic requirement for inotropic support
- •1.5. Central nervous system (CNS): hepatic encephalopathy West Haven Criteria score >2
- •1.6. Decompensated cirrhosis with requirement for organ support
- •1.7. Concomitant hepatobiliary disease (except hepatitis B or C viral disease), e.g., gallstones, primary sclerosing cholangitis, primary biliary cirrhosis
- •1.8. Known or suspected hepatic or extra hepatic malignancy, unless adequately treated or in complete remission for = 3 years
- •1.9. Concomitant pancreatitis
- •2. Use of treatments for hepatitis B or C virus within 12 months of randomisation, or anticipated use during the study
- •3. Use of the following drugs within 6 months of randomisation: Immuno-modulatory treatment (including azothiaprine, methotrexate, anti-TNF therapies)
- •4. Use of concomitant vasoactive drugs within 3 months of randomisation:
- •4.1. Beta blockers
- •4.2. Nitrates
- •4.3. Vasopressin or analogues
- •5. Use of the following drugs within 3 months of randomisation:
- •5.1. Systemic corticosteroids
- •5.2. Pentoxifylline
- •5.3. Potentially hepatotoxic drugs (including ? methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin)
- •5.4. Ursodeoxycholic acid (UDCA)
- •5.5. Known or suspected use of illicit drugs or drugs of abuse (allowed if medically prescribed or indicated)
- •6. Change in dose or regimen within 3 months of randomisation of:
- •6.1. Fibrates or statins
- •6.2. Angiotensin II receptor antagonist or angiotensin converting enzyme (ACE) inhibitor
- •7. Presence of human immunodeficiency virus (HIV)
- •8. If female: pregnant, lactating, or positive serum or urine pregnancy test
- •9. Body mass index (BMI) >40, or >35 with complications
- •10. Other concomitant disease or condition likely to significantly decrease life expectancy (e.g., moderate to severe congestive heart failure)
- •11. Any patient who has received any investigational drug or device within 4 months of dosing, or who is scheduled to receive another investigational drug or device during the course of this study
研究者
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