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    Summary
    EudraCT Number:2018-000819-25
    Sponsor's Protocol Code Number:DS102A-05-AH1
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-12-13
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedLatvia - SAM
    A.2EudraCT number2018-000819-25
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Orally Administered DS102 in Patients with Severe Acute Decompensated Alcoholic Hepatitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Study to Assess the Efficacy and Safety of Orally Administered DS102 in Patients with Severe Acute Decompensated Alcoholic Hepatitis.
    A.4.1Sponsor's protocol code numberDS102A-05-AH1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03452540
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAfimmune
    B.1.3.4CountryIreland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAfimmune
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAfimmune
    B.5.2Functional name of contact pointRegulatory Affairs Department
    B.5.3 Address:
    B.5.3.1Street AddressTrintech Building, South County Business Park
    B.5.3.2Town/ cityLeopardstown, Dublin
    B.5.3.3Post code18
    B.5.3.4CountryIreland
    B.5.4Telephone number0035312946380
    B.5.5Fax number0035312176117
    B.5.6E-mailafimmune.regulatory@afimmune.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDS102 Capsule
    D.3.2Product code DS102
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNepeleuton
    D.3.9.1CAS number 1667760-39-5
    D.3.9.2Current sponsor codeDS102
    D.3.9.3Other descriptive name15(S)-HYDROXY-EICOSAPENTAENOIC ACID ETHYL ESTER
    D.3.9.4EV Substance CodeSUB193616
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe Acute Decompensated Alcoholic Hepatitis
    E.1.1.1Medical condition in easily understood language
    Alcoholic Hepatitis
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001624
    E.1.2Term Alcoholic hepatitis
    E.1.2System Organ Class 100000004871
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy Objective:
    • To compare the efficacy of orally administered DS102 capsules versus placebo, in the treatment of adult patients with severe acute decompensated Alcoholic Hepatitis (AH).
    Safety Objective:
    • To compare the safety of orally administered DS102 capsules versus placebo, in the treatment of adult patients with severe acute decompensated AH.
    Pharmacokinetic Objective:
    • To evaluate the pharmacokinetics (PK) of 15(S)-HEPE following orally administered DS102 capsules, in six adult patients with AH in the initial pilot phase of the study, followed by trough level assessment of 15(S)-HEPE in all study participants.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal 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. Aspartate aminotransferase/alanine aminotransferase
    (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.
    E.4Principal 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:
    a. Evidence of chronic viral hepatitis (Hepatitis B DNA positive or HCV RNA positive).
    b. Biliary obstruction.
    c. Hepatocellular carcinoma.
    d. Wilsons disease.
    e. Budd Chiari Syndrome.
    f. 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 oromega-6 fatty acids in the four weeks prior to baseline.
    14. Patients dependent on inotropic support (adrenaline or noradrenaline), including Terlipressin.
    15. Active variceal hemorrhage on this admission requiring more than 2 units of blood to maintain hemoglobin level within 48 hours
    16. Presence of refractory ascites.
    17. Untreated or unresolved sepsis.
    18. Patients with cerebral hemorrhage, extensive retinal hemorrhage, 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.
    E.5 End points
    E.5.1Primary end point(s)
    • Percentage change in MELD score from baseline to Day 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline to Day 28
    E.5.2Secondary end point(s)
    •Change in total bilirubin from baseline to Day 7, 14, 21 and 28
    •Proportion of patients showing a 25% reduction of bilirubin at day 7, 14, 21, and 28.
    •Change in serum cytokeratin 18-M30/M65 from baseline to Day 7, 14, 21 and 28
    •Change in AST levels from Baseline to Day 7, 14, 21 and 28
    •Change in AST:ALT ratio from Baseline to Day 7, 14, 21, 28
    •Change in MDF score from baseline to Day 7, 14, 21 and 28.
    •Proportion of patients showing a 25% reduction in MELD score from baseline to Day 7, 14, 21 and 28
    •Change in MELD score from baseline to Day 7, 14 and 21
    •Change in modified Sequential Organ Failure Assessment (m-SOFA) from baseline to Day 7, 14, 21 and 28
    •Proportion of patients with a 2-point worsening of m-SOFA from baseline to Day 7, 14, 21 and 28.
    •Change in hepatic encephalopathy as assessed by West Haven criteria, from baseline at Day 7, 14, 21 and 28
    •Incidence of acute kidney injury over 28 days (defined by requiring medicinal or mechanical support)
    •Incidence of variceal haemorrhage, ascites or hepatic encephalopathy over 28 days

    Exploratory Endpoints
    •Survival at day 7, 14, 21, 28 and 90 using Kaplan-Meier Plot
    •Change in Gamma Glutamyl Transferase (GT) from Baseline to Day 7, 14, 21 and 28
    •Change in ALT from Baseline to Day 7, 14, 21 and 28.
    •Change in Child Pugh score from baseline to Day 7, 14, 21 and 28
    •Change in APACHE-II score from baseline to Day 7, 14 and 28
    •Change in Lille score from baseline to Day 7, 14 and 28

    Safety Endpoints
    •Treatment emergent (S)AE and SUSARs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 7, 14, 21 and 28
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belarus
    Belgium
    France
    Georgia
    Germany
    Latvia
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of trial is defined as ‘last patient last visit (LPLV)’. LPLV is defined as the date the Investigator reviews the last subject’s safety data and determines that no further evaluation is required for the subject to complete the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 101
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    If the patient is incapacitated, e.g. in the case of Grade II or Grade III hepatic encephalopathy, a relative or legal representative will be responsible for giving informed consent on behalf of the patient.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 78
    F.4.2.2In the whole clinical trial 126
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not different from expected normal treatment.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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