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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03452540
Recruitment Status : Terminated (Company Decision)
First Posted : March 2, 2018
Results First Posted : July 29, 2022
Last Update Posted : July 29, 2022
Sponsor:
Information provided by (Responsible Party):
Afimmune

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 adult patients with acute decompensated alcoholic hepatitis

Condition or disease Intervention/treatment Phase
Severe Acute Decompensated Alcoholic Hepatitis Drug: 1000mg DS102 (BID) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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.
Actual Study Start Date : November 28, 2018
Actual Primary Completion Date : June 19, 2019
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1000mg DS102 (BID)
Participants assigned to the open label pilot phase received 1000mg DS102 (BID)for 28 days.
Drug: 1000mg DS102 (BID)
Participants assigned to the open label pilot phase received 1000mg DS102 (BID)for 28 days.




Primary Outcome Measures :
  1. Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and SUSARs. [ Time Frame: Up to 28 days. ]
    To evaluate the safety of orally administered DS102 in the treatment of adult patients with severe acute decompensated AH.

  2. 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 [ Time Frame: 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.



Information from the National Library of Medicine

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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:

  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
  10. Able to swallow the provided study medication
  11. Not eligible for liver transplant during this hospitalisation

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
    3. Hepatocellular carcinoma
    4. Wilsons disease
    5. Budd Chiari Syndrome
    6. Non-alcoholic fatty liver disease
  9. History of or active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas).
  10. Previous entry into the study
  11. AST >400 U/L or ALT >270 U/L
  12. Treatment with any experimental drug within 30 days prior to Day 0 visit (Baseline), or 5 half-lives (whichever is longer).
  13. Patients who have used dietary supplements rich in omega-3 or omega-6 fatty acids in the four weeks prior to baseline.
  14. Patients dependent on inotropic support (adrenaline or noradrenaline), including Terlipressin
  15. Active variceal haemorrhage on this admission requiring more than 2 units of blood to maintain haemoglobin level within 48 hours
  16. Presence of refractory ascites
  17. Untreated or unresolved sepsis
  18. Patients with cerebral haemorrhage, extensive retinal haemorrhage, acute myocardial infarction (within last 6 weeks) or severe cardiac arrhythmias (not including atrial fibrillation)
  19. Known infection with HIV at screening.
  20. 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.
  21. Previous liver transplantation

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


Locations
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United States, Florida
Schiff Center for Liver Diseases (University Hospital Miami)
Miami, Florida, United States, 33136
Cleveland Clinic Florida
Miami, Florida, United States, 33331
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Virginia
Bon Secours Liver Institute of Richmond and Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, United States, 23602
Georgia
Batumi Referral Hospital
Batumi, Georgia
Saint Nikolozi Surgery Center
Kutaisi, Georgia
Sponsors and Collaborators
Afimmune
Investigators
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Principal Investigator: Mark Thursz Imperial College London
  Study Documents (Full-Text)

Documents provided by Afimmune:
Study Protocol  [PDF] November 14, 2018
Statistical Analysis Plan  [PDF] January 25, 2019

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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
Results First Posted: July 29, 2022
Last Update Posted: July 29, 2022
Last Verified: July 2022

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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
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders