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    Summary
    EudraCT Number:2021-003665-35
    Sponsor's Protocol Code Number:EIG-LMD-002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-11-04
    Trial 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 ConcernedGermany - BfArM
    A.2EudraCT number2021-003665-35
    A.3Full title of the trial
    A Phase 3, Randomized, Open-Label, Parallel Arm Study to Evaluate the Efficacy and Safety of 180 mcg Peginterferon Lambda-1a (Lambda) Subcutaneous Injection for 48 Weeks in Patients with Chronic Hepatitis Delta Virus (HDV) Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, Randomized, Open-Label, Parallel Arm Study to Evaluate the Efficacy and Safety of 180 mcg Peginterferon Lambda-1a (Lambda) Subcutaneous Injection for 48 Weeks in Patients with Chronic Hepatitis Delta Virus (HDV) Infection
    A.3.2Name or abbreviated title of the trial where available
    LIMT-2
    A.4.1Sponsor's protocol code numberEIG-LMD-002
    A.5.4Other Identifiers
    Name:INDNumber: 133 743
    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 SponsorEiger BioPharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportEiger BioPharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiorasi LLC
    B.5.2Functional name of contact pointAlexander Romanov
    B.5.3 Address:
    B.5.3.1Street Address18851 NE 29th Avenue, Suite 800
    B.5.3.2Town/ cityAventura
    B.5.3.3Post code33180
    B.5.3.4CountryUnited States
    B.5.6E-mailaromanov@biorasi.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/19/2190
    D.3 Description of the IMP
    D.3.1Product namePegylated Interferon Lambda-1a
    D.3.2Product code 361529
    D.3.4Pharmaceutical form Solution for injection/infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPeginterferon lambda-1A
    D.3.9.1CAS number 914617-98-4
    D.3.9.4EV Substance CodeSUB130479
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Hepatitis Delta Virus (HDV) Infection
    E.1.1.1Medical condition in easily understood language
    Chronic Hepatitis Delta Virus (HDV) Infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10019762
    E.1.2Term Hepatitis D
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the proportion of patients with HDV RNA < LLOQ (target detected [TD] or target not detected [TND]) at 24 weeks post-treatment (Week 72) following 48 weeks of treatment in Arm 1 to the proportion of patients with no treatment achieving HDV RNA level < LLOQ (TD or TND) at Week 12 in Arm 2.
    E.2.2Secondary objectives of the trial
    1.To compare the proportion of patients with HDV RNA < LLOQ1 (TND) at EOT (Week 48) and throughout 24 weeks post-treatment (Week 72) following 48 weeks of treatment in Arm 1 to the proportion of patients with no treatment achieving HDV RNA level < LLOQ (TD or TND) at Week 12 in Arm 2.
    2.To compare the composite virologic and biochemical response rate at 24 weeks post-treatment (Week 72) in Arm 1 and at Week 12 in Arm 2.
    Composite virologic and biochemical response is defined by both of the following bullets:
    o ≥ 2 log10 reduction in HDV RNA relative to baseline or HDV RNA < LLOQ (TD or TND); and
    o ALT normalization
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Individuals must meet all of the following inclusion criteria:
    1. a) Chronic HDV infection documented by a positive HDV antibody test or a detectable HDV RNA (≥5 IU/mL) by RT-PCR test for at least 3 months prior to Screening Visit 1
    AND
    b) Quantifiable HDV RNA (≥40 IU/mL) by RT-PCR test at Screening Visit 2
    2. Documented confirmed suppression of HBV DNA (< 100 IU/mL) following at least 12 weeks of anti-HBV NUC treatment with ETV or a TNF-based NUC (TDF or TAF) at Screening Visit 2.
    3. Serum ALT > upper limit of normal (ULN) and < 10 × ULN
    4. Patients categorized with Child-Turcotte-Pugh score of  5 with well compensated liver disease.
    5. Male or female, 18 to 70 years of age, inclusive.
    6. Body mass index (BMI) of ≥ 18.0 kg/m2 and < 40 kg/m2.
    7. Electrocardiogram (ECG) demonstrating no acute ischemia or clinically significant abnormality and a corrected QT interval by Fridericia correction formula (QTcF) < 450 ms for male patients and < 460 ms for female patients.
    8. Females of childbearing potential and males with partners of childbearing potential must agree to use adequate methods of contraception during the study and through 90 days after the last dose of study medication. Females of childbearing potential are all those except women who are surgically sterile, who have medically documented bilateral ovarian failure, or who are at least 1 year postmenopausal (12 consecutive months with no menstruation).
    For females: 2 of the following contraceptive methods are required, with at least 1 being a barrier method:
     Hormonal contraceptives for 27 days before dosing
     Intrauterine device (IUD) in place 27 days before dosing
     Intrauterine hormone-releasing system (IUS), in place 27 days prior to dosing
     Double-barrier methods (use of condom [male partner] with either diaphragm or cervical cap, in each case plus spermicide) from screening
     Surgical sterilization of the partner (vasectomy 1 month before screening)
     Sexual abstinence
    For males, the following are considered acceptable options:
     Surgical sterilization (vasectomy 1 month before screening) or
     Use of both of the following contraceptive methods from screening:
     Consistent and correct use of a male condom with or without spermicide
     Partner must use a hormonal contraceptive or a nonhormonal barrier method (IUD or diaphragm with spermicide or cervical cap with spermicide).
    9. Willing and able to comply with study procedures and provide written informed consent.
    10. Able to read and understand a language in which an informed consent form and other patient study documents are available.
    11. Able to self-administer medication orally and via subcutaneous (SC) injection (following training by site personnel).
    12. Dilated retinal examination at Screening Visit 2, performed by an ophthalmologist or other ocular specialist.
     For patients evidencing retinal abnormalities at screening, the investigator should review the findings with the ophthalmologist and the medical monitor to determine if the patient may be enrolled in the study.
     Patients with other, ocular findings may be enrolled, but should be monitored closely during the study, with a detailed ocular review of symptoms performed at each visit, and should undergo periodic repeat ophthalmologic examinations during treatment, at a frequency recommended by the treating ophthalmologist.
    E.4Principal exclusion criteria
    Individuals meeting any of the following criteria will be excluded from the study:
    1. Participation in a clinical trial with use of any investigational agent within 30 days before Screening Visit 1.
    2. Treatment with interferons (IFNs) or immunomodulators within 6 months before Screening Visit 1 or refractory to prior IFN treatment.
    3. History or evidence of any hypersensitivity to IFNs or other substances contained in the study medication.
    4. Female patients who are pregnant or breastfeeding. Female patients must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours of start of IP.
    5. Patients who are not eligible for treatment with either ETV or a TNF-based NUC based on prior demonstrated treatment intolerance and/or failure

    For a more detailed list of Exclusions Based on Disease and Exclusions Based on Concurrent Medication Use please refer to Sections 4.2.2 and 4.3.2 of the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    · The primary endpoint is the proportion of patients with HDV RNA < LLOQ (TD or TND), defined as follows for each treatment arm:
    o Lambda arm (Arm 1): the proportion of patients with HDV RNA < LLOQ (TD or TND) at 24 weeks post-treatment (Week 72) following 48 weeks of treatment
    o No treatment arm (Arm 2): the proportion of patients with HDV RNA < LLOQ (TD or TND) at Week 12

    Note: All efficacy analyses will be performed in patients who have received at least 1 dose of study drug.
    E.5.1.1Timepoint(s) of evaluation of this end point
    HDV RNA < LLOQ (TD or TND) at 24 weeks Post-TRx (Arm1) versus 12 weeks Post-No TRx (Arm 2)
    E.5.2Secondary end point(s)
    1. The proportion of patients with HDV RNA < LLOQ, defined as follows for each treatment arm:
    o Lambda arm (Arm 1): the proportion of patients with HDV RNA < LLOQ (TND) at EOT (Week 48) and throughout 24 weeks post-treatment (Week 72)
    o No treatment arm (Arm 2): the proportion of patients with HDV RNA < LLOQ (TND) at Week 12.

    2. Composite virologic and biochemical response rate, defined as follows for each treatment arm:
    o Lambda arm (Arm 1): the proportion of patients with both (a) ≥ 2 log10 reduction in HDV RNA relative to baseline or HDV RNA < LLOQ (TD or TND)]; and (b) ALT normalization at 24 weeks post-treatment (Week 72)
    o No-treatment arm (Arm 2): the proportion of patients with both (a) ≥ 2 log10 reduction in HDV RNA relative to baseline or HDV RNA < LLOQ (TD or TND)]; and (b) ALT normalization at Week 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. The proportion of patients with HDV RNA< LLOQ, defined as follows for each treatment arm:
    o Lambda arm(Arm 1): the proportion of patients with HDV RNA<LLOQ(TND) at EOT(Week 48) and throughout 24 weeks posttreatment(Week 72)
    o No treatment arm(Arm 2): the proportion of patients with HDV RNA<LLOQ(TND) at Week12.
    2.Composite virologic and biochemical response rate, defined as follows for each treatment arm:o Lambda arm(Arm 1): the proportion of patients with both(a) ≥ 2 log10 reduction in HDV RNA relative to baseline or HDV RNA<LLOQ(TD or TND)]; and(b)ALT normalization at 24 weeks posttreatment(Week 72)
    o No-treatment arm(Arm 2):the proportion of patients with both(a)≥2log10 reduction in HDV RNA relative to baseline or HDV RNA< LLOQ(TD or TND)];and (b)ALT normalization at Week 12.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    no treatment for 12 weeks followed by IMP treatment for 48 weeks treatment
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Israel
    United States
    Moldova, Republic of
    Russian Federation
    Turkey
    Ukraine
    Belgium
    Bulgaria
    France
    Germany
    Italy
    Romania
    Spain
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 150
    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)
    Subjects who have ended their participation in the trial with Peginterferon Lambda-1a (Lambda) will return to a treatment according to the current standard of care.
    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 Decision2022-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-09-13
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