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    Summary
    EudraCT Number:2011-000728-14
    Sponsor's Protocol Code Number:ANA773-602
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-05-03
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-000728-14
    A.3Full title of the trial
    A Phase 2a, Randomized, Open-Label Study in Patients with Chronic Hepatitis C Viral Infection to Assess the Safety, Tolerability, Pharmacodynamics, and Antiviral Activity of ANA773 Tosylate Administered with Ribavirin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical investigation in the early stages of drug development to evaluate the safety and tolerability of a new drug for the treatment of hepatitis C when it is given to hepatitis C patients together with ribavirin.
    A.4.1Sponsor's protocol code numberANA773-602
    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 SponsorAnadys Development, LTD
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAnadys Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAnadys Development, LTD
    B.5.2Functional name of contact pointJames L Freddo, MD
    B.5.3 Address:
    B.5.3.1Street Address16 Charlotte Square
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH2 4DF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number18585303736
    B.5.5Fax number18585271540
    B.5.6E-mailjfreddo@anadyspharma.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 nameANA773 Tosylate Capsule
    D.3.2Product code ANA773 Tosylate Capsule
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 C Viral Infection
    E.1.1.1Medical condition in easily understood language
    Chronic Hepatitis C Viral 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 13.1
    E.1.2Level LLT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    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
    Evaluate the safety and tolerability of oral ANA773 tosylate (ANX8414) administered with ribavirin in patients with chronic hepatitis C viral (HCV) infection
    E.2.2Secondary objectives of the trial
    Evaluate the anti-viral and pharmacodynamic effects of ANA773 tosylate (ANX8414) administered with ribavirin in patients with chronic HCV infection.

    Evaluate different dosing schedules of ANA773 tosylate (ANX8414) administered with ribavirin in patients with chronic HCV infection.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female adults between 18 and 65 years of age, inclusive;

    Patients should have chronic, documented, hepatitis C infection;

    HCV genotype 1;

    IL28B genotypic polymorphism CT;

    Naïve to or have relapsed from prior pegylated interferon-alpha based therapy;

    HCV RNA ³ 375,000 copies/mL or ³ 75,000 IU/mL;
    E.4Principal exclusion criteria
    FFemale patients who are pregnant or who are breast-feeding;

    For treatment naïve patients: any previous treatment for HCV infection;

    For patients who relapsed after prior pegylated interferon + ribavirin treatment: previous treatment with an experimental therapy for HCV infection;

    History of cirrhosis on prior liver biopsy;

    History of biochemical or other signs of decompensated liver disease:

    History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC;

    History of alcohol abuse and/or other drug addiction < 1 year prior to enrollment in the study or, a positive drug screen for amphetamines or cocaine;

    Poorly-controlled diabetes mellitus;

    Congestive heart failure or unstable cardiopulmonary condition, renal disease, or hemoglobinopathy;

    History of seizure disorder;

    History of severe psychiatric illness, including severe depression, history of suicidal ideation, suicidal attempts, or psychosis requiring medication;

    Medical condition that requires use of systemic corticosteroids (e.g., severe asthma, severe arthritis or autoimmune conditions, organ transplantation, or adrenal insufficiency); corticosteroid nasal sprays, inhaled steroids for asthma and/or topical steroids are permissible;

    Concurrent therapy with any immune-modulating agents, e.g., interleukins, interferons, vaccines, or immunosuppressive agents;

    Received warfarin or other anticoagulants during the 21 days immediately prior to Screening, or is expected to require warfarin or other anticoagulants during the study;

    One or more additional known primary or secondary causes of liver disease, other than hepatitis C;

    Any other concurrent medical condition likely to preclude compliance with the schedule of evaluations, or likely to confound the efficacy or safety observations;

    Any immunologically mediated disease (e.g., Crohn’s disease, ulcerative colitis);

    History of a significant medical condition (except hepatitis C infection) that may interfere with the absorption, distribution, metabolism, or elimination of the study medication, or with the clinical and laboratory safety assessments in this study;

    Malignancy within the last 5 years (squamous or basal cell skin cancers are allowed);

    History of acute or chronic pancreatitis;

    12-lead ECG showing Corrected QTc interval > 450 msec (Bazett’s correction), QRS > 120 msec, or Clinically significant abnormalities;

    Donated or lost > 500 mL of blood < 30 days prior to enrollment into this study;

    Participated in other clinical studies of a new chemical entity within 30 days prior to study randomization;

    Active infection (cold, flu) within 14 days prior to the start of study or had a febrile illness within 5 days prior to administration of the first dose of study medication.

    Any medical contraindications to Peg-INF or RBV therapy;
    E.5 End points
    E.5.1Primary end point(s)
    Safety: Patients who receive at least 1 dose of study drug will be considered evaluable for safety. Safety will be evaluated by adverse events and clinically significant changes from pre-treatment baseline in laboratory values, vital signs, ECG tracings, and findings during physical examinations.

    Pharmacodynamics: At the following timepoints, the following parameters for HCV RNA will be determined:
    Baseline: the average of the sample taken between Day -10 and Day -4, and Day 1 at pre-dose
    Nadir: maximum decrease from baseline
    EOT: end of treatment is the average of the Day 27 and Day 28 HCV RNA concentrations
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety: End of Treatment with triple combination of SOC + ANA773 Tosylate, 34 days

    Pharmacodynamics: End of Treatment with triple combination of SOC + ANA773 Tosylate, 34 days
    E.5.2Secondary end point(s)
    n/a
    E.5.2.1Timepoint(s) of evaluation of this end point
    n/a
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Day 34 is the End of Study visit for patients randomized to ANA773 Tosylate capsule + ribavirin. This visit is not required for those patients randomized to SOC.
    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: 40
    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 No
    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 40
    F.4.2.2In the whole clinical trial 40
    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 Decision2011-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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