Efficacy and Safety of Orally Administered DS102 in Patients With Acute Alcoholic Hepatitis

Stopped early · Phase 2

Conditions studied: Severe Acute Decompensated Alcoholic Hepatitis

In brief

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

Key facts

Study ID

NCT03452540

Run by

Afimmune

People needed

9

Starts

2018-11-28

Expected to finish

2020-03-31

Last updated by the study team

2022-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Schiff Center for Liver Diseases (University Hospital Miami) — Miami, Florida, United States
• Cleveland Clinic Florida — Miami, Florida, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Bon Secours Liver Institute of Richmond and Bon Secours Liver Institute of Hampton Roads — Newport News, Virginia, United States
• Batumi Referral Hospital — Batumi, Georgia
• Saint Nikolozi Surgery Center — Kutaisi, Georgia

Full record on ClinicalTrials.gov

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