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    Summary
    EudraCT Number:2019-001139-30
    Sponsor's Protocol Code Number:YP39364
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-05-17
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2019-001139-30
    A.3Full title of the trial
    A SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY STUDY OF RO7049389 IN: (1) SINGLE- (WITH OR WITHOUT FOOD) AND MULTIPLE- (WITH MIDAZOLAM) ASCENDING DOSES IN HEALTHY VOLUNTEERS; (2) PATIENTS CHRONICALLY INFECTED WITH HEPATITIS B VIRUS (3) PATIENTS WITH CHRONIC HEPATITIS B
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate whether RO707049389 is safe and how it is processed by the body, and its antiviral effect at different dose levels and in different population (healthy people, patients infected with hepatitis B virus and patients had chronic active hepatitis B)
    A.4.1Sponsor's protocol code numberYP39364
    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 SponsorF. Hoffman-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4161 688 1111
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameRO7049389
    D.3.2Product code Ro 7049389/F09
    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 INNN.A.
    D.3.9.1CAS number 0467420-42-4
    D.3.9.2Current sponsor codeRO7049389
    D.3.9.3Other descriptive nameRo 704-9389/F09
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Hepatitis B
    E.1.1.1Medical condition in easily understood language
    chronic liver disease caused by chronic hepatitis B virus 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 10008910
    E.1.2Term Chronic hepatitis B
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate anti-viral effect (functional cure) of treatment with RO7049389 on top of Standard of Care.
    Functional cure is defined as HBV DNA < lower limit of quantification (LLOQ, 20 IU/mL) with HBsAg loss (<0.05 international unit/milliliter (IU/mL)) at 24 weeks post-treatment
    E.2.2Secondary objectives of the trial
    - To further characterize the efficacy profile of RO7049389 on top of Standard of Care over time, including HBsAg loss, HBsAg seroconversion, quantitative HBsAg change from baseline, HBeAg loss, HBeAg seroconversion, quantitative HBeAg change from baseline, HBV DNA < LLOQ,
    HBV DNA change from baseline in different proof of mechanism (POM) cohorts of Part 3 and in subgroups of baseline HBeAg +/- patients, or of baseline high / low HBsAg level patients.
    - To characterize the plasma PK profiles of RO7049389 and its metabolites.
    - To assess the long-term safety and tolerability of RO7049389 on top of SoC (a NUC with or without Peg-IFN).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult male and female patients, 18 to 60 years of age, inclusive
    - Positive test for HBsAg or HBV DNA or positive HBeAg for more than 6 months prior to screening.
    - HbsAg >250 IU/mL at screening
    - For Cohorts only enrolling NUC-suppressed CHB patients (e.g., POM Cohort A), patients must qualify for the following criteria: a). Patients treated with a single NUC (entecavir, tenofovir alafenamide, or tenofovir disoproxil fumarate) for ≥12 months. Patients must be on the same NUC therapy for at least 3 months before screening. b). At least one result showed HBV DNA <60 IU/mL at least 6 months prior to screening; and HBV DNA <20 IU/mL at screening by Roche Cobas assay. c). ALT ≤2 x ULN at screening and at Day -1 (can be checked by local lab result).

    - For Cohorts only enrolling anti-HBV treatment-naïve and immune-active patients (e.g.,POM Cohort B and Cohort C), patients must qualify for the following criteria: a). Previous anti-HBV treatments for <30 days in total, and did not receive any anti-HBV treatments within 3 months prior to the first study dose. b). HBV DNA at screening ≥2 x 104 IU/mL for HBeAg positive patients, or 2 x 103 IU/mL for HbeAg negative patients. c). ALT at screening between 1–5 x ULN and ALT <5 x ULN at Day -1 (can be checked by local lab result).
    E.4Principal exclusion criteria
    - History or other evidence of bleeding from esophageal varices.
    - Evidence of liver cirrhosis or decompensated liver disease such as ascites, esophageal or gastric varices, splenomegaly, nodular liver, jaundice, hepatic encephalopathy.
    - one or more of the following laboratory abnormalities at screening:
    - Total serum bilirubin > ULN (exception Gilbert’s disease)
    - International normalized ratio (INR) >1.1 ULN.
    - Serum albumin < 3.0 g/dL (<30 g/L).
    - Platelet count <140,000 cells/mm3
    - Hemoglobin <12 g/dL (females) or <13 g/dL (males).
    - White blood cell count <2500 cell/mm3.
    - Neutrophil count <1500 cell/mm3 (<1200 cell/mm3 if considered a physiological variant in a patient of African descent).

    - Diagnosed or suspected hepatocellular carcinoma as evidenced by screening alpha-fetoprotein (AFP) ≥100 mg/mL. If AFP >ULN, absence of mass/findings suspicious for HCC must be demonstrated by ultrasound or CT or MRI within the screening period.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving functional cure (HBV DNA <LLOQ with HBsAg loss at 24 weeks post-treatment)
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks post-treatment
    E.5.2Secondary end point(s)
    Proportion of patients with HBsAg loss, HBsAg seroconversion, HBeAg loss, HBeAg seroconversion.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12, 24, 36 and week 48 during treatment, 24 week post treatment
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    NUC (non –IMP)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned1
    E.8.5The trial involves multiple Member States No
    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
    Bulgaria
    Hong Kong
    Korea, Republic of
    New Zealand
    Romania
    Singapore
    Taiwan
    Thailand
    E.8.7Trial has a data monitoring committee No
    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 the study is defined as the date when the last study subject last observation (LSLO) occurs.
    LSLO is expected to occur 24 weeks after the last dose is administered in Part 3.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 55
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 55
    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)
    Currently, the Sponsor does not have any plans to provide RO7049389 to the patients
    after the end of the study, or when patients discontinue or have been withdrawn from the
    study. The Sponsor will evaluate whether to continue providing RO7049389 to patients
    after the main study is over, in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    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 Decision2019-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-25
    P. End of Trial
    P.End of Trial StatusOngoing
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