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    The EU Clinical Trials Register currently displays   43977   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-003167-54
    Sponsor's Protocol Code Number:EIG-LNF-011
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-03
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-003167-54
    A.3Full title of the trial
    A Phase 3, Matrix Design, Partially Double-Blind, Randomized Study of the Efficacy and Safety of 50 mg Lonafarnib/100 mg Ritonavir BID with and without 180 mcg PEG IFN-alfa-2a for 48 Weeks Compared with PEG IFN-alfa-2a Monotherapy and Placebo Treatment in Patients Chronically Infected with Hepatitis Delta Virus Being Maintained on Anti-HBV Nucleos(t)ide Therapy (D-LIVR)
    Studio di fase 3, con disegno a matrice, parzialmente in doppio cieco, randomizzato sull’efficacia e la sicurezza di lonafarnib 50 mg / ritonavir 100 mg, due volte al giorno (BID), con e senza 180 mcg di PEG IFN-alfa-2a, per 48 settimane rispetto a PEG IFN-alfa-2a in monoterapia e trattamento con placebo in pazienti con infezione cronica da virus dell’epatite delta in terapia di mantenimento con nucleos(t)idi anti-HBV (D-LIVR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to evaluate the efficacy and safety of the study drug named Lonafarnib administrated with Ritonavir, in patients Chronically Infected with Hepatitis Delta Virus Being Maintained on Anti-HBV Nucleos(t)ide Therapy (D-LIVR)
    Studio di ricerca volto a valutare l’efficacia e la sicurezza del farmaco di studio chiamato lonafarnib amministrato con ritonavir, in pazienti con infezione cronica da virus dell’epatite delta in terapia di mantenimento con nucleos(t)idi anti-HBV (D-LIVR)
    A.3.2Name or abbreviated title of the trial where available
    D-LIVR
    D-LIVR
    A.4.1Sponsor's protocol code numberEIG-LNF-011
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03719313
    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 organisationEiger BioPharmaceuticals, Inc.
    B.5.2Functional name of contact pointColin Hislop
    B.5.3 Address:
    B.5.3.1Street Address2155 Park Blvd.
    B.5.3.2Town/ cityPalo Alto
    B.5.3.3Post codeCA 94306
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16504556406
    B.5.5Fax number0000000
    B.5.6E-mailchislop@eigerbio.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 Yes
    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 nameEntecavir Aurobindo
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNENTECAVIR
    D.3.9.1CAS number 142217-69-4
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 2
    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 Yes
    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 nameTenofovir disoproxil
    D.3.2Product code [NA]
    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 INNtenofovir disoproxil
    D.3.9.1CAS number 147127-20-6
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number245
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name NORVIR
    D.2.1.1.2Name of the Marketing Authorisation holderAbbvie Inc
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameRitonavir
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Tablet
    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 INNRitonavir
    D.3.9.1CAS number 155213-67-5
    D.3.9.2Current sponsor codeNorvir
    D.3.9.4EV Substance CodeSUB10342MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 4
    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 Yes
    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 nameTenofovir alafenamide fumarate
    D.3.2Product code [NA]
    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 INNTenofovir alafenamide fumarate
    D.3.9.1CAS number 1392275-56-7
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 5
    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/3/13/1225
    D.3 Description of the IMP
    D.3.1Product nameLonafarnib
    D.3.2Product code [MK-6336, SCH-66336, BP1515-YYC]
    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 INNLonafarnib
    D.3.9.1CAS number 193275-84-2
    D.3.9.2Current sponsor codeLNF, SARASAR, SCH 66336, EBP994
    D.3.9.4EV Substance CodeSUB21038
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 6
    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 Yes
    D.2.1.1.1Trade name PEGASYS - 180 MCG SOLUZIONE INIETTABILE 4 FLACONCINI 1 ML USO SOTTOCUTANEO
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE REGISTRATION LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 namepegylated interferon-alfa-2a Injection
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNINTERFERONE ALFA-2A PEGILATO
    D.3.9.1CAS number 198153-51-4
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB16452MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 7
    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 Yes
    D.2.1.1.1Trade name PEGASYS
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namepegylated interferon-alfa-2a Injection
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Solution for infusion
    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 ALFA-2A
    D.3.9.1CAS number 198153-51-4
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB16452MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 8
    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 Yes
    D.2.1.1.1Trade name Norvir
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameRitonavir
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Tablet
    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 INNRITONAVIR
    D.3.9.1CAS number 155213-67-5
    D.3.9.2Current sponsor codeNorvir
    D.3.9.4EV Substance CodeSUB10342MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    The proposed indication for lonafarnib coadministered with ritonavir is for the treatment of chronic HDV infection.
    Approximately 5% of HBV-infected individuals are infected with HDV worldwide. Chronic HDV infection leads to more severe liver disease than HBV mono-infection, is associated with accelerated fibrosis progression, and has a higher risk of developing hepatocellular carcinoma. Currently no satisfactory therapy for HDV infection exist.
    L'indicazione proposta per lonafarnib co-somministrato con ritonavir è per il trattamento dell'infezione cronica da HDV. Circa il 5% degli individui infetti da HBV sono infetti da HDV in tutto il mondo. L'infezione cronica da HDV porta a malattie del fegato più gravi rispetto alla monoinfezione da HBV, è associata a progressione della fibrosi accelerata e presenta un rischio più elevato di sviluppare carcinoma epatocellulare.Attualmente non c'è una terapia soddisfacente per l'infezione da HDV.
    E.1.1.1Medical condition in easily understood language
    The proposed study is for the treatment of patients with chronic HDV infection.
    Lo studio proposto è per il trattamento di pazienti con infezione cronica da HDV.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10019763
    E.1.2Term Hepatitis delta
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives are as follows:
    • To compare the composite virologic and biochemical response rate at end-of-treatment (EOT) (Week 48) in patients who receive LNF 50 mg/RTV 100 mg BID vs patients who receive placebo.
    • To compare the composite virologic and biochemical response rate at EOT (Week 48) in patients who receive LNF 50 mg/RTV 100 mg BID with PEG IFN-alfa-2a 180 mcg QW vs patients who receive placebo.
    Composite virologic and biochemical response is defined as a = 2 log10 reduction in HDV ribonucleic acid (RNA) level and alanine aminotransferase (ALT) normalization relative to baseline. Meeting either primary objective will lead to an efficacy conclusion.
    Gli obiettivi principali sono i seguenti:
    • Confrontare il tasso di risposta virologica e biochimica composita alla fine del trattamento (EOT) (Settimana 48) in pazienti che ricevono LNF 50 mg / RTV 100 mg BID vs pazienti che ricevono placebo.
    • Confrontare il tasso di risposta virologica e biochimica composita all'EOT (Settimana 48) in pazienti che ricevono LNF 50 mg / RTV 100 mg BID con PEG IFN-alfa-2a 180 mcg QW vs pazienti che ricevono placebo.
    La risposta virologica e biochimica composita è definita come una riduzione di <sub> 2 </ sub> log10 del livello di acido ribonucleico dell'HDV (RNA) e della normalizzazione dell'alanina aminotransferasi (ALT) rispetto al basale. Il raggiungimento dell'obiettivo primario porterà a una conclusione di efficacia.
    E.2.2Secondary objectives of the trial
    The secondary objectives are as follows (see Protocol for details):
    • Virologic Response
    • Biochemical Response
    • Histologic Response
    • Lower Limit of Quantitation (LLOQ) Virologic Response
    • Composite Virologic and Biochemical Response
    • Individual Virologic and Biochemical Response
    • Quality of Life
    • Safety
    Gli obiettivi secondari sono i seguenti (vedi Protocollo per i dettagli):
    • Risposta virologica
    • Risposta biochimica
    • Risposta istologica
    • Risposta virologica a limite inferiore di quantificazione (LLOQ)
    • Risposta virologica e biochimica composita
    • Risposta individuale virologica e biochimica
    • Qualità della vita
    • Sicurezza
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Chronic HDV infection for at least 6 months in duration, documented by a positive HDV antibody (Ab) test and HDV RNA >=500 IU/mL by quantitative polymerase chain reaction (qPCR) assay prior to initiation of study Treatment.
    Non-genotype 1 HDV will be capped at 15% of total enrollment. Patients with a screening HDV RNA viral load < or = 4 log10 will make up between 35% and 45% of the total population.
    2. Demonstrable suppression of HBV DNA (< 20 IU/mL) following a minimum 12 weeks of anti-HBV nucleos(t)ide treatment with entecavir or tenofovir (TDF or TAF) prior to initiating study therapy.
    3. Serum ALT > 1.3 x upper limit of the normal range (ULN) and < 10 x ULN.
    4. Willing and able to comply with study procedures and provide written informed consent.
    5. Need to be able to read and understand language where the patient is participating in the study.
    6. Able to self-administer medication orally and via subcutaneous (SC) injection.
    7. Male and female participants who are 18 years of age or above.
    8. Body mass index (BMI) of = 18 kg/m2 and weight = 45 kg.
    9. Liver biopsy within 45 days of Day 1 demonstrating evidence of chronic hepatitis. If no liver biopsy is available, the patient must be willing to consent to and have no contraindication to liver biopsy.
    10. ECGs demonstrating no acute ischemia or clinically significant (CS) abnormality and a corrected QT interval by Fridericia correction formula (QTcF) < 450 ms.
    11. Normal dilated retinal examination.
    12. Sexually active female patients of childbearing potential and sexually active male patients with partners of childbearing potential must agree to use adequate methods of contraception during the study. Females of childbearing potential are all those except women who are surgically sterile, who have medically documented ovarian failure, or who are at least 1 year postmenopausal.
    For female patients:
    • Progestin-based hormonal contraception (implant, injection, oral) associated with inhibition of ovulation for > or = 3 moths before screening. Use of a progestin-based implant or injection method requires the additional use of a barrier method (use of condom [male partner] or diaphragm with spermicide or cervical cap with spermicide) from screening. Use of a progestin-only, oral method requires the additional use of double barrier methods (use of condom [male partner] with either diaphragm with spermicide or cervical cap with spermicide) from screening or
    • Intrauterine device (IUD) or intrauterine system (IUS) in place = 3 months before screening AND a barrier method (use of condom [male partner] or diaphragm with spermicide or cervical cap with spermicide) from screening, or
    • Surgical sterilization of the partner (vasectomy = 1 month before screening) AND a barrier method (use of condom [male partner] or diaphragm with spermicide or cervical cap with spermicide) from screening, or
    • Double-barrier methods (use of condom [male partner] with either diaphragm with spermicide or cervical cap with spermicide) from screening.
    For male patients:
    • Surgical sterilization (vasectomy = 1 month before screening) AND a barrier method (use of condom or diaphragm with spermicide or cervical cap with spermicide) from screening, or
    • Consistently and correctly use a condom from screening AND female partner must agree to use a hormonal contraceptive, a nonhormonal nonbarrier method (eg, copper IUD), or a nonhormonal barrier method (eg, diaphragm with spermicide or cervical cap with spermicide).
    1. Infezione cronica da HDV per almeno 6 mesi di durata, documentata da un test positivo dell'anticorpo HDV (Ab) e HDV RNA >=500 IU / mL mediante reazione a catena della polimerasi quantitativa (qPCR) prima dell'inizio del trattamento in studio.
    L'HDV non-genotipo 1 sarà limitato al 15% del totale delle iscrizioni. I pazienti con una carica virale di HDV RNA di screening = 4 log10 costituiranno tra il 35% e il 45% della popolazione totale.
    2. Soppressione dimostrabile del DNA dell'HBV (<20 UI / ml) a un minimo di 12 settimane di trattamento con nucleos (t) ide anti-HBV con entecavir o tenofovir (TDF o TAF) prima di iniziare la terapia di studio.
    3. ALT sierico> 1,3 x limite superiore dell'intervallo normale (ULN) e <10 x ULN.
    4. Disposti e in grado di rispettare le procedure di studio e fornire il consenso informato scritto.
    5. È necessario essere in grado di leggere e capire la lingua in cui il paziente partecipa allo studio.
    6. In grado di auto-somministrare farmaci per via orale e tramite iniezione sottocutanea (SC).
    7. Partecipanti di sesso maschile e femminile che abbiano compiuto 18 anni o più.
    8. Indice di massa corporea (BMI) = 18 kg / m2 e peso = 45 kg.
    9. Biopsia epatica entro 45 giorni dal primo giorno che dimostra evidenza di epatite cronica. Se non è disponibile la biopsia epatica, il paziente deve essere disposto a consentire e non avere controindicazioni alla biopsia epatica.
    10. ECG che non presentano ischemia acuta o anormalità clinicamente significativa (CS) e un intervallo QT corretto mediante formula di correzione di Fridericia (QTcF) <450 ms.
    11. Esame retinico dilatato normale.
    12. Le pazienti sessualmente attive in età fertile e i pazienti sessualmente attivi maschi con partner in età fertile devono concordare l'uso di metodi contraccettivi adeguati durante lo studio. Le donne in età fertile sono tutte quelle ad eccezione di donne che sono chirurgicamente sterili, con insufficienza ovarica documentata da un medico o che hanno almeno 1 anno di postmenopausa.
    Per le pazienti di sesso femminile:
    • Contraccezione ormonale a base di progestinico (impianto, iniezione, orale) associata a inibizione dell'ovulazione per un periodo > o = a 3 mesi prima dello screening. L'uso di un impianto o metodo di iniezione basato su Progestinico richiede l'uso aggiuntivo di un metodo di barriera (uso del preservativo [partner maschile] o del diaframma con spermicida o cappuccio cervicale con spermicida) dallo screening. Il solo uso di un metodo orale progestinico richiede l'uso aggiuntivo di metodi a doppia barriera (uso del preservativo [partner maschile] con diaframma con spermicida o con cappuccio cervicale con spermicida) dallo screening,
    o
    • Dispositivo intrauterino (IUD) o sistema intrauterino (IUS) in atto = 3 mesi prima dello screening E un metodo di barriera (uso del preservativo [partner maschile] o diaframma con spermicida o cappuccio cervicale con spermicida) dallo screening, o
    • Sterilizzazione chirurgica del partner (vasectomia = 1 mese prima dello screening) E un metodo di barriera (uso del preservativo [partner maschile] o diaframma con spermicida o cappuccio cervicale con spermicida) dallo screening, o
    • Metodi a doppia barriera (uso del preservativo [partner maschile] con diaframma con spermicida o tappo cervicale con spermicida) dallo screening.
    Per i pazienti di sesso maschile:
    • Sterilizzazione chirurgica (vasectomia = 1 mese prima dello screening) E un metodo di barriera (uso del preservativo o diaframma con spermicida o cappuccio cervicale con spermicida) dallo screening, o
    • Utilizzare coerentemente e correttamente un preservativo dallo screening E la partner femminile deve accettare l'uso di un contraccettivo ormonale, un metodo non-ormonale non-barriera (ad es. Rame IUD) o un metodo di barriera non ormonale (ad es. Diaframma con spermicida o cappuccio cervicale con spermicida).
    E.4Principal exclusion criteria
    1.Participation in a clinical trial with, or use of, any investigational agent within 30 days or 5 half-lives, whichever is longer, before screening
    2.Previous use of LNF within 12 months before pre screening/screening
    and all others exclusion criteris, as stated in the protocol
    1. Partecipazione a uno studio clinico con o uso di qualsiasi agente investigativo entro 30 giorni o 5 emivite, a seconda di quale periodo sia più lungo, prima dello screening
    2. Uso precedente di LNF entro 12 mesi prima del pre-screening / screening
    e tutti gli altri criteri di esclusione, come riportato dal protocollo
    E.5 End points
    E.5.1Primary end point(s)
    • To compare the composite virologic and biochemical response rate at end-of-treatment (EOT) (Week 48) in patients who receive LNF 50 mg/RTV 100 mg BID vs patients who receive placebo.
    • To compare the composite virologic and biochemical response rate at EOT (Week 48) in patients who receive LNF 50 mg/RTV 100 mg BID with PEG IFN-alfa-2a 180 mcg QW vs patients who receive placebo.
    Composite virologic and biochemical response is defined as a = 2 log10 reduction in HDV ribonucleic acid (RNA) level and alanine aminotransferase (ALT) normalization relative to baseline. Meeting
    either primary objective will lead to an efficacy conclusión.
    • Per confrontare il tasso di risposta virologica e biochimica composita alla fine del trattamento (EOT) (Settimana 48) in pazienti che ricevono LNF 50 mg / RTV 100 mg BID vs pazienti che ricevono placebo.
    • Confrontare il tasso di risposta virologica e biochimica composita all'EOT (Settimana 48) in pazienti che ricevono LNF 50 mg / RTV 100 mg BID con PEG IFN-alfa-2a 180 mcg QW vs pazienti che ricevono placebo.
    La risposta virologica e biochimica composita è definita come una riduzione di = 2 log10 del livello di acido ribonucleico dell'HDV (RNA) e della normalizzazione dell'alanina aminotransferasi (ALT) rispetto al basale. Incontro
    o l'obiettivo primario porterà ad una conclusione conclusiva.
    E.5.1.1Timepoint(s) of evaluation of this end point
    -Week 48
    48 settimane
    E.5.2Secondary end point(s)
    • Virologic Response
    • Biochemical Response
    • Histologic Response
    • Lower Limit of Quantitation (LLOQ) Virologic Response
    • Composite Virologic and Biochemical Response
    • Individual Virologic and Biochemical response
    • Quality of Life
    • Safety
    • Risposta virologica
    • Risposta biochimica
    • Risposta istologica
    • Risposta virologica a limite inferiore di quantificazione (LLOQ)
    • Risposta virologica e biochimica composita
    • Risposta individuale virologica e biochimica
    • Qualità della vita
    • Sicurezza
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 48 and week 24 post treatment
    Settimana 48 2 settimana 24 dopo il trattamento
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Parzialmente in doppio ceco
    Partially double blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Israel
    Moldova, Republic of
    Mongolia
    New Zealand
    Pakistan
    Taiwan
    Turkey
    United States
    Belgium
    Bulgaria
    France
    Germany
    Italy
    Romania
    Spain
    Sweden
    Switzerland
    United Kingdom
    Greece
    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
    Last visit from last subject
    Ultima visita dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 400
    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)
    Patients who demonstrate a meaningful reduction of HDV RNA by >= 2log10 or better but do not achieve durables levels (ie, < LLOQ [40 IU/ml]) for 24 weeks post treatment, may be offered a re treatment option in a rollover treatment protocol (EIG-LNF-012). Patients randomized into the placebo groups may also be enrolled. A long term follow up study is planned to assess durability of response and disease associated outcomes (EIG-LNF-014). Patients may EIG-LNF-011 and in EIG-LNF-012 may enroll.
    Per pz con riduzione dell'RNA dell'HDV di> = 2 log10 o superiore che non raggiungono livelli durevoli (cioè <LLOQ [40 UI/ml]) per 24 sett dopo trattamento, può essere offerta opzione di retrattamento in protocollo rollover(EIG-LNF-012). Anche i pazienti randomizzati nei gruppi placebo possono essere arruolati. È previsto studio di follow-up a lungo termine per valutare la durata della risposta e gli esiti associati alla malattia (EIG-LNF-014). POssono essera arruolati i pazientiEIG-LNF-011/012
    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 Decision2019-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-05
    P. End of Trial
    P.End of Trial StatusOngoing
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