A Randomised, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Orally Administered DS102 in Patients with Severe Acute Decompensated Alcoholic Hepatitis.

Afimmune0 个研究点目标入组 126 人开始时间: 2018年12月13日最近更新: 2019年2月28日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 126

研究概览入排标准研究者记录与标识符相似试验

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

入选标准

•1. Male or female patients aged 18 years and older.
•2. Total bilirubin of = 5 mg/dl (85µmol/l).
•3. Patients with definite or probable AH.
•4. MELD =18 at baseline visit
•5. MDF =32 at baseline visit
•6. AST >50 U/L
•7. Aspartate aminotransferase/alanine aminotransferase
•(AST:ALT) ratio > 1.5
•8. Female patients, or female partners of male patients, of child
•bearing potential must use highly effective birth control
•methods or have a sterilised partner for the duration of the
•study. Highly effective birth control methods are defined as
•methods that can achieve a failure rate of less than 1% per
•year when used consistently and correctly. Such methods
•include intrauterine device or sexual abstinence.
•Note: A woman is considered of child bearing potential
•(WOCBP), i.e. fertile, following menarche and until becoming
•post-menopausal unless permanently sterile. Permanent
•sterilisation methods include hysterectomy, bilateral
•salpingectomy and bilateral oophorectomy.
•Note: Hormonal contraceptives are contraindicated in
•patients with severe hepatic diseases and are not acceptable
•as a birth control method in this study.
•Note: Sexual abstinence is considered a highly effective
•method only if defined as refraining from heterosexual
•intercourse during the entire period of risk associated with
•the study treatments. The reliability of sexual abstinence
•needs to be evaluated in relation to the duration of the
•clinical trial and the preferred and usual lifestyle of the
•9. Patient and/or legally authorised representative must provide informed consent.
•10. Able to swallow the provided study medication.
•11. Not eligible for liver transplant during this hospitalisation.
•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 101
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

排除标准

•1. Pregnant or lactating females.
•2. Spontaneous liver function improvement defined by decrease of bilirubin level and MDF of >10% within 5 days of hospital admission.
•3. Grade 4 hepatic encephalopathy (West Haven Criteria).
•4. Type 1 hepatorenal syndrome (HRS) or a serum creatinine >2 x ULN or the requirement for haemodialysis.
•5. History of hypersensitivity to any substance in DS102 capsules or placebo capsules.
•6. Alcohol abstinence of >6 weeks prior to screening.
•7. Duration of clinically apparent jaundice >3 months prior to baseline.
•8. Other causes of liver disease including:
•a. Evidence of chronic viral hepatitis (Hepatitis B DNA positive or HCV RNA positive).
•b. Biliary obstruction.
•c. Hepatocellular carcinoma.
•d. Wilsons disease.
•e. Budd Chiari Syndrome.
•f. Non-alcoholic fatty liver disease.
•9. History of or active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas).
•10. Previous entry into the study.
•11. AST >400 U/L or ALT >270 U/L.
•12. Treatment with any experimental drug within 30 days prior to Day 0 visit (Baseline), or 5 half-lives (whichever is longer).
•13. Patients who have used dietary supplements rich in omega-3 oromega-6 fatty acids in the four weeks prior to baseline.
•14. Patients dependent on inotropic support (adrenaline or noradrenaline), including Terlipressin.
•15. Active variceal hemorrhage on this admission requiring more than 2 units of blood to maintain hemoglobin level within 48 hours
•16. Presence of refractory ascites.
•17. Untreated or unresolved sepsis.
•18. Patients with cerebral hemorrhage, extensive retinal hemorrhage, acute myocardial infarction (within last 6 weeks) or severe cardiac arrhythmias (not including atrial fibrillation).
•19. Known infection with HIV at screening.
•20. Significant systemic or major illnesses other than liver disease that, in the opinion of the investigator, would preclude or interfere with treatment with DS102 and/or adequate follow up.
•21. Previous liver transplantation.

研究者

发起方

Afimmune

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