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

• Status: Suspended
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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 patients with acute decompensated alcoholic hepatitis

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Afimmune

Criteria

Inclusion Criteria:

• Male or female subject aged 18 years and older

• Total bilirubin of ≥ 5 mg/dl (85μmol/l)

• Patients with definite or probable alcoholic hepatitis (AH)

• Women of child bearing potential should be willing to practice appropriate contraception throughout the treatment period

• Able to swallow the provided study medication

• Not eligible for liver transplant during this hospitalisation

Exclusion Criteria:

• Pregnant or lactating females.

• History of hypersensitivity to any substance in DS102 capsules or placebo capsules.

• Duration of clinically apparent jaundice >3 months prior to baseline

• Other causes of liver disease including:

1. Evidence of chronic viral hepatitis (Hepatitis B DNA positive or Hepatitis C (HCV) RNA positive)

2. Biliary obstruction

3. Hepatocellular carcinoma

4. Wilsons disease

5. Budd Chiari Syndrome

6. Non-alcoholic fatty liver disease

• History of or active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas).

• Treatment with any experimental drug within 30 days prior to Day 0 visit (Baseline), or 5 half-lives (whichever is longer).

• Untreated or unresolved sepsis

• Known infection with HIV at screening or randomization

• 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