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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03452540
Recruitment Status : Not yet recruiting
First Posted : March 2, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Afimmune

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Severe Acute Decompensated Alcoholic Hepatitis Drug: DS102 Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: DS102
Participants in this group will receive 2000mg DS102 capsules daily.
 Drug: DS102
Participants will receive 1000mg DS102 capsules twice per day.
Placebo Comparator: Placebo
Participants in this group will receive placebo capsules daily.
 Other: Placebo
Participants will receive placebo capsules twice per day.


Outcome Measures
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Primary Outcome Measures :
  1. % change in model for end-stage liver disease (MELD) score from baseline [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Change in serum bilirubin [ Time Frame: 28 days ]
  2. Change in aspartate aminotransferase (AST) levels [ Time Frame: 28 days ]
  3. Change in AST:ALT (alanine transaminase) ratio [ Time Frame: 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452540


Contacts
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Contact: Karen Doyle +3532946380 karen.doyle@afimmune.com
Contact: Markus Weissbach +3532946380

Sponsors and Collaborators
Afimmune
More Information
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Responsible Party: Afimmune
ClinicalTrials.gov Identifier: NCT03452540    
Other Study ID Numbers: DS102A-05-AH1
2018-000819-25 ( EudraCT Number )
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders