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

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.

NCT03452540•Afimmune

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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. 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 subject
•9. Patient and/or legally authorised representative must provide informed consent
+1 more criteria

Exclusion Criteria

•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:
•1. Evidence of chronic viral hepatitis (Hepatitis B DNA positive or HCV RNA positive)
•2. Biliary obstruction
+17 more criteria

Locations (8)

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

Key Dates

Start Date

November 28, 2018

Primary Completion Date

June 19, 2019

Completion Date

March 31, 2020

Last Updated

July 29, 2022

Enrollment

ACTUAL participants

Conditions

Severe Acute Decompensated Alcoholic Hepatitis

Interventions

1000mg DS102 (BID)

DRUG