NCT03452540终止2 期
A Randomised, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Orally Administered DS102 in Patients With Acute Decompensated Alcoholic Hepatitis.
Afimmune8 个研究点 分布在 2 个国家目标入组 9 人开始时间: 2018年11月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 8
- 主要终点
- Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and SUSARs.
研究概览
简要总结
The purpose of this randomised, double-blind, placebo-controlled, phase II study is to assess the efficacy and safety of orally administered DS102 in adult patients with acute decompensated alcoholic hepatitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18 years and older
- •Total bilirubin of ≥ 5 mg/dl (85μmol/l)
- •Patients with definite or probable AH
- •MELD ≥18 at baseline visit
- •MDF ≥32 at baseline visit
- •AST ≥50 U/L
- •AST':ALT ratio > 1.5
- •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 subject
- •Patient and/or legally authorised representative must provide informed consent
- •Able to swallow the provided study medication
- •Not eligible for liver transplant during this hospitalisation
排除标准
- •Pregnant or lactating females.
- •Spontaneous liver function improvement defined by decrease of bilirubin level and MDF of >10% within 5 days of hospital admission
- •Grade 4 hepatic encephalopathy (West Haven Criteria)
- •Type 1 hepatorenal syndrome (HRS) or a serum creatinine >2 x ULN or the requirement for haemodialysis
- •History of hypersensitivity to any substance in DS102 capsules or placebo capsules.
- •Alcohol abstinence of >6 weeks prior to screening
- •Duration of clinically apparent jaundice >3 months prior to baseline
- •Other causes of liver disease including:
- •Evidence of chronic viral hepatitis (Hepatitis B DNA positive or HCV RNA positive)
- •Biliary obstruction
- •Hepatocellular carcinoma
- •Wilsons disease
- •Budd Chiari Syndrome
- •Non-alcoholic fatty liver disease
- •History of or active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas).
- •Previous entry into the study
- •AST >400 U/L or ALT >270 U/L
- •Treatment with any experimental drug within 30 days prior to Day 0 visit (Baseline), or 5 half-lives (whichever is longer).
- •Patients who have used dietary supplements rich in omega-3 or omega-6 fatty acids in the four weeks prior to baseline.
- •Patients dependent on inotropic support (adrenaline or noradrenaline), including Terlipressin
- •Active variceal haemorrhage on this admission requiring more than 2 units of blood to maintain haemoglobin level within 48 hours
- •Presence of refractory ascites
- •Untreated or unresolved sepsis
- •Patients with cerebral haemorrhage, extensive retinal haemorrhage, acute myocardial infarction (within last 6 weeks) or severe cardiac arrhythmias (not including atrial fibrillation)
- •Known infection with HIV at screening.
- •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.
- •Previous liver transplantation
研究组 & 干预措施
1000mg DS102 (BID)
Experimental
Participants assigned to the open label pilot phase received 1000mg DS102 (BID)for 28 days.
干预措施: 1000mg DS102 (BID) (Drug)
结局指标
主要结局
Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and SUSARs.
时间窗: Up to 28 days.
To evaluate the safety of orally administered DS102 in the treatment of adult patients with severe acute decompensated AH.
Descriptive Statistics for Plasma Total 15(S)-HEPE and Unesterified 15(S)-HEPE Pharmacokinetic Results for 1000 mg BD DS102 Administered Orally Twice-daily to Patients With Alcoholic Hepatitis
时间窗: Up to 7 days
Descriptive Statistics for Plasma Total 15(S)-HEPE and Unesterified 15(S)-HEPE Pharmacokinetic Results for 1000 mg BD DS102 Administered Orally Twice-daily to Patients with Alcoholic Hepatitis.
次要结局
未报告次要终点
研究者
研究点 (8)
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