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    Summary
    EudraCT Number:2011-002777-27
    Sponsor's Protocol Code Number:CF101-231GL
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-18
    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 number2011-002777-27
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Daily CF101 Administered Orally in Subjects with Elevated Intraocular Pressure
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Daily CF101 in Patients With High Intraocular Pressure
    A.4.1Sponsor's protocol code numberCF101-231GL
    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 SponsorCan-Fite BioPharma Ltd.
    B.1.3.4CountryIsrael
    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 supportCan-Fite BioPharma Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCan-Fite BioPharma Ltd.
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street Address10 Bareket st.
    B.5.3.2Town/ cityPetach Tikva
    B.5.3.3Post code49170
    B.5.3.4CountryIsrael
    B.5.4Telephone number+97239241114
    B.5.5Fax number+97239249378
    B.5.6E-mailinfo@canfite.co.il
    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 nameCF101
    D.3.2Product code CF101
    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 INNmethyl 1-[N6-(3-iodobenzyl)-adenin-9-yl]-β-D-ribofuronamide
    D.3.9.1CAS number 152918-18-8
    D.3.9.2Current sponsor codeCF101
    D.3.9.3Other descriptive nameIB-MECA; ALB 7208
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients with elevate intraocular pressure
    E.1.1.1Medical condition in easily understood language
    patients with elevate intraocular pressure
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLGT
    E.1.2Classification code 10018307
    E.1.2Term Glaucoma and ocular hypertension
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine the effects of oral CF101 in lowering intraocular pressure (IOP) when administered twice daily for 16 weeks in subjects with elevated IOP; and Determine the safety of oral CF101 in this subject population
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, 18 years of age and over;
    2. Ocular hypertension or open-angle glaucoma in at least 1 eye,
    diagnosed as any of the following:
    a. Untreated ocular hypertension without glaucomatous
    anatomic or VF changes; or
    b. Glaucoma diagnosed within the past 2 months but
    untreated;
    c. Previously treated glaucoma, provided that previous
    medication treatment has been inefficacious and/or
    intolerable, and has therefore been discontinued at least
    3 weeks prior to Baseline; or
    d. Currently treated glaucoma with inadequate IOP
    control, meaning that IOP remains above target
    pressure as judged by the Investigator despite ≥3 weeks
    of treatment with a standard topical regimen (for
    guidance, the European Glaucoma Society defines
    “target pressure” as follows: “In most cases a peak
    IOP = 8 mm – 15 mmHg on a diurnal curve, or 30%
    IOP reduction from baseline”);
    3. In subjects receiving a standard topical treatment regimen (per
    2.d. above), the regimen and dose have not changed within 3
    weeks of Screening, and are expected to remain stable
    throughout the treatment period;
    4. At both Screening and Baseline, IOP in at least 1 eye
    (“candidate” eye) is >21 mmHg at 0800-1000 hours and >21
    mmHg in at least 1 measurement at least 3 hours following the
    first (see Section 8.2.2);
    5. Corneal thickness between 500 and 580 microns in both eyes
    (see Section 8.2.2);
    6. Corrected visual acuity +0.18 logMAR or better by Early
    Treatment Diabetic Retinopathy Study (ETDRS) methodology
    in the candidate eye (equivalent to 20/30);
    7. Females of child-bearing potential must have a negative blood
    pregnancy test at screening and throughout the study, to be
    eligible for, and continue participation in, the study;
    8. Females of child-bearing potential must be willing to use 2
    methods of contraception deemed adequate by the Investigator
    (eg, oral contraceptive pills plus a barrier method) to be
    eligible for, and continue participation in, the study;
    9. Ability to complete the study in compliance with the protocol;
    and
    10. Ability to understand and provide written informed consent.
    E.4Principal exclusion criteria
    1. IOP >32 mmHg in either eye;
    2. History of angle-closure glaucoma;
    3. Anatomically narrow angles in either eye (ie, ≥75% of the
    circumference of the angle must be ≥Grade 2 by Shaffer
    criteria2);
    4. In subjects with glaucoma, advanced VF defect in either eye,
    determined on reliable testing using the Humphrey Full-
    Threshold Algorithm for the Glaucoma Hemifield Test (see
    Section 8.2.2), defined as either:
    a. Mean deviation worse than -16 dB, or
    b. Threat to fixation (sensitivity 10 dB or worse affecting
    either or both test points closest to the point of fixation
    in the upper hemifield and at either or both the
    corresponding test points in the lower hemifield);
    5. In subjects with ocular hypertension, a score of >12 points on
    The Ocular Hypertension Treatment Study Group and
    European Glaucoma Prevention Study Group Primary Open-
    Angle Glaucoma Risk Table (see Appendix 2 in Section 17);
    6. Documented disc hemorrhage within the past 5 years in either
    eye;
    7. Secondary cause of IOP elevation;
    8. Glaucoma laser treatment in candidate eye within the past 3
    months;
    9. Clinically significant ocular trauma to candidate eye within the
    past 6 months;
    10. Any major ocular surgery in the past, including
    keratorefractive surgery, in candidate eye, except for
    uncomplicated cataract surgery performed greater than 6
    months prior to Screening;
    11. Astigmatism >3 diopters in either eye;
    12. Clinically significant acute or chronic ocular disease (eg,
    corneal edema, uveitis, severe keratoconjunctivitis sicca, active
    ocular infection, active herpes simplex keratitis, blepharitis, or
    acute conjunctivitis) that might interfere with the study;
    13. Concomitant contact lens use;
    14. Concomitant use of systemic medication that may affect IOP
    (eg, beta blockers, corticosteroids, calcium channel blockers,
    ACE inhibitors, or carbonic anhydrase inhibitors); however,
    systemic antihypertensive medications are allowed providing
    that the dose and regimen have been stable for at least 3
    months prior to Screening and are expected to remain stable
    throughout the trial;
    15. Any abnormality preventing reliable applanation tonometry;
    16. Presence of uncontrolled asthma;
    17. Presence of uncontrolled arterial hypertension or symptomatic
    hypotension;
    18. Significant cardiac arrhythmia or conduction block, congestive
    heart failure (New York Heart Association Class 3-4), or any
    other evidence of clinically significant heart disease or
    clinically significant findings on screening ECG;
    19. Hemoglobin level <9.0 gm/L at screening;
    20. Platelet count <125,000/mm3 at screening;
    21. White blood cell count <3500/mm3 at screening;
    22. Serum creatinine level greater than 1.5 times the laboratory’s
    upper limit of normal (ULN) at screening;
    23. Liver aminotransferase levels greater than 2 times the
    laboratory’s ULN at screening;
    24. Known or suspected immunodeficiency or human
    immunodeficiency virus positivity;
    25. Known infection with hepatitis B or C;
    26. Pregnancy, planned pregnancy, lactation, or inadequate
    contraception as judged by the Investigator;
    27. Previous receipt of CF101;
    28. History of malignancy within the past 5 years (excluding basal
    cell carcinoma of the skin and ≤3 cutaneous squamous cell
    carcinomas, all of which have been completely excised);
    29. Active drug or alcohol dependence;
    30. Significant acute or chronic medical, ophthalmic, neurologic,
    or psychiatric illness that, in the judgment of the Investigator,
    could compromise subject safety, limit the subject’s ability to
    complete the study, and/or compromise the objectives of the
    study;
    31. Participation in another investigational drug or vaccine trial
    concurrently or within 30 days; or
    32. Other conditions which would confound the study evaluations
    or endanger the safety of the subject.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: Effects on IOP;
    Safety: AE reporting, physical examination, vital signs, ophthalmologic and slit lamp examination, (VF) assessments, clinical laboratory testing
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 - 16 weeks
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned7
    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
    India
    Israel
    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 Last Subject
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 44
    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)
    No
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-22
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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