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    Summary
    EudraCT Number:2014-004201-33
    Sponsor's Protocol Code Number:Heparc-2007
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-21
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-004201-33
    A.3Full title of the trial
    A Multicenter, Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Combination with Entecavir or Tenofovir in Patients with Chronic Hepatitis B Virus (HBV) Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to continue to assess a novel medicine in the treatment of patients with Chronic Hepatitis B Virus (HBV) Infection (follow-on study from previous study)
    A.4.1Sponsor's protocol code numberHeparc-2007
    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 SponsorArrowhead Research Corporation
    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 supportArrowhead Research Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationICON Clinical Research
    B.5.2Functional name of contact pointIlse-Maria Nolan
    B.5.3 Address:
    B.5.3.1Street AddressSandyford Business Park
    B.5.3.2Town/ cityDublin
    B.5.3.3Post code18
    B.5.3.4CountryIreland
    B.5.4Telephone number35312564659
    B.5.6E-maililse-maria.nolan@iconplc.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 nameARC-520 Injection
    D.3.2Product code ARC-520
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Yet Assigned
    D.3.9.1CAS number 1603138-54-0
    D.3.9.2Current sponsor codeAD0009 Duplex
    D.3.9.3Other descriptive nameAD0009: Cholesterol-conjugated siHBV-74
    D.3.9.4EV Substance CodeSUB171444
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number13
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet assigned
    D.3.9.1CAS number 1603138-75-5
    D.3.9.2Current sponsor codeAD0010 Duplex
    D.3.9.3Other descriptive nameAD0010: Cholesterol-conjugated siHBV-77
    D.3.9.4EV Substance CodeSUB171444
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number13
    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 Virus Infection
    E.1.1.1Medical condition in easily understood language
    Chronic Hepatitis B Virus Infection
    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 19.0
    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 determine the percentage of initial responders to ARC-520 therapy achieving a 1-log reduction in HBsAg at week 36 of the extension study compared to baseline. Baseline is defined as the average of the pre-dose values in the primary Heparc-2002 and Heparc-2003 studies.
    E.2.2Secondary objectives of the trial
    • To determine the incidence and frequency of adverse events possibly or probably related to treatment as a measure of safety and tolerability of ARC-520 when co-administered with a fixed dose of entecavir or tenofovir in patients with chronic HBV infection.
    • To determine the percentage of initial responders achieving HBsAg loss (qualitative HBsAg) at weeks 36, 48 and 60.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who showed a ½ log or greater reduction in serum HBsAg levels from baseline to day 71 ± 3 or day 99 ± 3 of the primary Heparc-2002 and Heparc-2003 studies.
    2. Patients who receive their first dose within 2 months of their day 113 end-of-study visit of the primary Heparc-2002 and Heparc-2003 studies.
    3. Able to provide written informed consent prior to the performance of any study specific procedures.
    4. Have no abnormalities in 12-lead ECG assessment (measured after the patient is supine for at least 3 minutes) that, in the opinion of the principal investigator, may compromise patient’s safety in this study.
    5. Willing and able to comply with all study assessments and adhere to the protocol schedule.
    6. Have no new abnormal finding of clinical relevance at the screening evaluation.
    7. Must be HBsAg (+).
    8. HBV DNA < 200 IU/mL.
    9. Patients must use 2 effective methods of contraception (double barrier contraception or hormonal contraceptive along with a barrier contraceptive) (both male and female partners) during the study and for 3 months following the last study treatment (ARC-520).

    NOTE: Heparc-2002/2003 Day 85 or after assessments may be used to support entry into Heparc-2007, as applicable, as long as the assessment was done no more than 60 days prior to screening.
    E.4Principal exclusion criteria
    1. Female patients have a positive pregnancy test or are lactating.
    2. Acute signs of hepatitis/other infection (eg, moderate fever, jaundice, nausea, vomiting, and abdominal pain) evident within 4 weeks of screening and/or at the screening examination.
    3. Hepatic transaminases (ALT or AST) > 5X upper limits of normal.
    4. Use of prescription medication (including anticoagulants) within 14 days prior to administration of study treatment except for topical products without systemic absorption, statins (except rosuvastatin), hypertensive medications, or hormonal contraceptives (females).
    5. Patients with any of the following laboratory abnormalities:
    -a. Serum creatinine > 1.5 mg/dL (132.6 μmol/L)
    -b. International normalized ratio (INR) > 1.25 × ULN
    -c. Platelets < 70,000 cells per mL
    6. Patients with a mean Fridericia corrected interval between the start of the Q wave and the end of the T wave (QTcF) > 450 msec for males and > 470 msec for females.
    7. Has had major surgery within 3 months of screening.
    8. Has evidence of severe systemic acute inflammation, sepsis, or hemolysis.
    9. Diagnosed with a significant psychiatric disorder that would prevent participation in the study.
    10. Unable or unwilling to return for all scheduled study visits.
    11. Has any other condition that, in the opinion of the principal investigator, would render the patient unsuitable for enrolment, or could interfere with his/her participation in the study.

    NOTE: Heparc-2002/2003 Day 85 or after assessments may be used to support entry into/exclusion from Heparc-2007, as applicable, as long as the assessment was done no more than 60 days prior to screening.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline (mean of pre-dose values) to Day 113 in log qHBsAg following administration of ARC-520 by dose and treatment group
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 113
    E.5.2Secondary end point(s)
    Change from baseline in log qHBsAg by treatment and dose for each timepoint.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each visit
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 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 concerned8
    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
    Germany
    Hong Kong
    Korea, Republic of
    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
    End of Study is stated in the protocol as 28 days post last dose (Day 253 ± 3). The patients' last visist will be a follow-up visist 24 weeks ± 3 days post last dose.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 120
    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 will be monitored for HBV virology, AEs, and exploratory PD measures for a total of 24 weeks after the last dose.
    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 Decision2016-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-29
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