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    Summary
    EudraCT Number:2022-003009-31
    Sponsor's Protocol Code Number:HH007
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-11-07
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2022-003009-31
    A.3Full title of the trial
    Atorvastatin for patients with Philadelphia-negative chronic myeloproliferative neoplasms - Essential thrombocythemia, polycythemia vera and prefibrotic myelofibrosis
    Atorvastatin til patienter med de Philadelphia-negative kronisk myeloproliferative neoplasier - essentiel trombocytose, polycythemia vera og prefibrotisk myelofibrose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Atorvastatin for patients with Philadelphia-negative chronic myeloproliferative neoplasms - Essential thrombocythemia, polycythemia vera and prefibrotic myelofibrosis
    Atorvastatin til patienter med de Philadelphia-negative kronisk myeloproliferative neoplasier - essentiel trombocytose, polycythemia vera og prefibrotisk myelofibrose
    A.4.1Sponsor's protocol code numberHH007
    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 SponsorZealand University Hospital, dept. of Haematology
    B.1.3.4CountryDenmark
    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 supportRegion Zealand
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZealand University Hospital, dept. of Haematology
    B.5.2Functional name of contact point.
    B.5.3 Address:
    B.5.3.1Street AddressKøgevej 7-13
    B.5.3.2Town/ cityRoskilde
    B.5.3.3Post code4000
    B.5.3.4CountryDenmark
    B.5.4Telephone number47 32 48 00
    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.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameAtorvastatin
    D.3.4Pharmaceutical form 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 INNAtorvastatin
    D.3.9.1CAS number 134523-00-5
    D.3.9.4EV Substance CodeSUB05600MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 80
    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
    Essential thrombocythemia, Polycythemia vera, prefibrotic myelofibrosis
    E.1.1.1Medical condition in easily understood language
    blood cancer
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10077465
    E.1.2Term Myeloproliferative neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. In patients with MPNs undergoing Best Available Therapy (BAT), to investigate the effect of adjuvant treatment with atorvastatin assessed by inflammatory markers and cell counts.
    E.2.2Secondary objectives of the trial
    2. To asses biochemical markers for inflammation and disease burden in a population of MPN patients who are followed prospectively during statin treatment, as well as to assess the relationship to the development of symptoms, thrombosis and transformation to myelofibrosis and AML.
    3. To asses the thrombophilia profile in MPN patients before and during atorvastatin treatment.
    4. To asses the number and functionality of circulating immune cells before and during atorvastatin treatment.
    5. To investigate the effect of statins on the gut microbiome and possible correlations in treatment response.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    WHO 2016 classified ET, PV or prePMF with thrombocytosis and/or leukocytosis.
    2. Age > 18 years.
    3. Expected survival > 3 years.
    4. If ongoing cytoreductive treatment, this must have started > 3 months ago, and there must not be an expected change of dose or treatment type in the coming year.
    5. Not taking statin beforehand
    E.4Principal exclusion criteria
    Uncontrolled autoimmune or chronic inflammatory disorder (covers unexplained inflammatory condition, inadequately treated inflammatory condition, and treatment with strong immunosuppressive medications).
    2. Other active cancer (excluding squamous cell carcinoma or basal cell carcinoma in the skin and prostate cancer treated with "watchful waiting").
    3. Pregnancy
    4. Contraindications against starting atorvastatin:
    a. Active liver disease or persistent transaminase elevation of unknown cause.
    b. Concomitant use of potent CYP3A4 inhibitors
    c. Combination with gemfibrozil or ciclosporin
    d. Allergy to statins
    E.5 End points
    E.5.1Primary end point(s)
    Primary:
    1. Inflammatory parameters: hs-CRP, inflammatory cytokines, leukocyte count, platelet count and neutrophil/lymphocyte ratio (NLR).
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline, 1, 3, 6, 7, 9, 12 months
    E.5.2Secondary end point(s)
    Secondary:
    2. Hematological parameters: hemoglobin, hematocrit, erythrocyte count, LDH and urate.
    3. Inflammatory parameters and coagulation factors: Ferritin, fibrin D-dimer, SR, fibrinogen.
    4. MPN-related symptoms.
    5. Number of phlebotomies and blood transfusions.
    6. Types and dose of cytoreductive treatment.
    7. Molecular biological parameters: JAK2-V617F allele burden (qPCR) and CALR mutation allele burden. JAK2-V617F positive patients only have JAK2-V617F allele burden taken and CALR mutation positive patients only have CALR allele burden taken.
    8. Cholesterols: HDL, LDL, VLDL, total cholesterol + triglycerides - Measures of effect of statins and related to correlate statins effect on lipid profile and inflammatory biomarkers. Also measures of compliance to atorvastatin treatment.
    9. Markers of oxidative stress in urine: 8-oxoGuo and 8-oxodG.
    10. Next generation exome sequencing
    11. Immune cell studies and NETosis activity.
    12. ROTEM study for thrombophilia/coagulation status.
    13. Assessment of endothelial dysfunction on the basis of EndoPAT measurements.
    14. Eye examination.
    15. Registration of side effects for atorvastatin.
    16. Quality of life form MPN-SAF, which was part of the department's ongoing assessment of quality of life for hematology patients
    17. Plasma proteomics and plasma metabolomics
    18. Microbiome studies
    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline, 1, 3, 6, 7, 9, 12 months (not every secondary endpoint will be assesed at each timepoint)
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    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: 20
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 20
    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 state40
    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)
    BAT
    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 Decision2022-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-23
    P. End of Trial
    P.End of Trial StatusOngoing
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