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    Summary
    EudraCT Number:2017-001156-55
    Sponsor's Protocol Code Number:C1171002
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-13
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2017-001156-55
    A.3Full title of the trial
    A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study To Evaluate Safety, Tolerability, And Pharmacodynamics Of PF-05221304 Administered Daily For 16-Weeks To Adult Subjects With Nonalcoholic Fatty Liver Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, Tolerability, and Pharmacodynamics of PF-05221304 in subjects with Nonalcoholic Fatty Liver Disease
    A.4.1Sponsor's protocol code numberC1171002
    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 SponsorPfizer Inc. 235 East 42nd Street, New York, NY 10017
    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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.5Fax number+13037391119
    B.5.6E-mailclinicaltrials.govcallcenter@pfizer.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.3.2Product code PF-05221304
    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 INNnot applicable
    D.3.9.3Other descriptive namePF-05221304
    D.3.9.4EV Substance CodeSUB187496
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 2
    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.3.2Product code PF-05221304
    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 INNnot applicable
    D.3.9.3Other descriptive namePF-05221304
    D.3.9.4EV Substance CodeSUB187496
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 3
    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.3.2Product code PF-05221304
    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 INNnot applicable
    D.3.9.3Other descriptive namePF-05221304
    D.3.9.4EV Substance CodeSUB187496
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 4
    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.3.2Product code PF-05221304
    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 INNnot applicable
    D.3.9.3Other descriptive namePF-05221304
    D.3.9.4EV Substance CodeSUB187496
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 2
    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
    Nonalcoholic Fatty Liver Disease (NAFLD)
    E.1.1.1Medical condition in easily understood language
    Nonalcoholic Fatty Liver Disease (NAFLD)
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10053219
    E.1.2Term Non-alcoholic steatohepatitis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    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 the dose-response for the effect on liver fat with a range of PF-05221304 doses administered daily in adults with nonalcoholic fatty liver disease (entire study population)
    E.2.2Secondary objectives of the trial
    • To evaluate the dose-response for the effect on ALT with a range of PF-05221304 doses administered daily in the 1st tier stratification comprising of adults with diagnosed/presumed nonalcoholic steatohepatitis, only
    • To evaluate the safety and tolerability of a range of PF-05221304 doses administered daily in adults with nonalcoholic fatty liver disease (entire study population)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects between the ages of 18 (or the minimum country-specific age of consent if > 18) and 70 years, inclusive, at Visit 1 (Screen 1):
    • Male and female subjects of childbearing potential must agree to use highly effective method(s) of contraception.
    • Female subjects of childbearing potential must not be pregnant, breastfeeding, or planning to become pregnant for the duration of their participation in this study and within 28-days following last dose of blinded investigational product.
    • Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
    a. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state, with a single repeat assessment, via the sponsor-identified central laboratory, permitted to assess postmenopausal state, if needed;
    b. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    c. Have medically confirmed ovarian failure;
    All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
    • At Pre-Qualification and Visit 1 (Screen 1), in all female subjects, serum beta human chorionic gonadotropin (β-hCG) level, with a single repeat assessment, via the sponsor-identified central laboratory, permitted to assess non-pregnant state, if needed.

    2. At Pre-Qualification, pass the hula-hoop test with a single repeat assessment, permitted, if needed, to assess eligibility.

    3. At Pre-Qualification, have an arm circumference compatible with the largest blood pressure cuff size available at individual sites with a single repeat assessment, permitted, if needed, to assess eligibility.

    4. At Pre-Qualification and Visit 1 (Screen 1), total body weight of > 50 kg (110 lbs) with BMI ≥ 25 kg/m2 (for sites in Africa, Europe, North America) or BMI ≥ 22.5 kg/m2 (for sites in Asia), with a single repeat assessment of body weight and/or BMI permitted to assess eligibility, if needed, at each of these 2 visits.

    5. At Pre-Qualification and Visit 1 (Screen 1), meet the following criteria for liver fat, based on assessment via FibroScan®, with a single repeat permitted to assess eligibility, if needed, at each of these 2 visits:
    • CAPTM ≥ 280 dB/m;

    6. At Pre-Qualification and Visit 1 (Screen 1), meet the following criteria, as assessed by sponsor-identified central laboratory; with a single repeat on any of these parameters permitted to assess eligibility, if needed, at each of these 2 visits:
    • International Normalized Ratio (INR) ≤ 1.3;
    • Albumin ≥ lower limit of normal (LLN);
    • Platelet count ≥ 0.95x LLN;
    • Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L);
    • HbA1C ≤ 9.5%;
    • Fasting plasma glucose ≤ 270 mg/dL (15.0 mmol/L);
    • Total bilirubin < 1.5x upper limit of normal (ULN) and direct bilirubin ≤ ULN.

    7. Documented liver biopsy ≤ 24-months prior to Visit 1 (Screen 1) with histological evidence of NASH in order to be classified in the sub-population with biopsy-proven NASH, only.

    8. In those without biopsy-proven NASH, only, at Pre-Qualification and Visit 1 (Screen 1), meet the following criteria for liver stiffness, based on assessment via FibroScan®, with a single repeat permitted to assess eligibility, if needed, at each of these 2 visits:
    • LSM ≥ 7.0 kPa – classified as presumed NASH;
    • LSM < 7.0 kPa – classified as NAFLD with likely minimal inflammation and fibrosis;

    9. In those without biopsy-proven NASH, only, at Pre-Qualification and Visit 1 (Screen 1), meet the following criteria, as assessed by the sponsor-identified central laboratory, with a single repeat permitted to assess eligibility, if needed, at each of these 2 visits:
    • ALT > ULN and ≤ 5x ULN – classified as presumed NASH;
    • ALT ≤ 1.25x ULN – classified as NAFLD with likely minimal inflammation and fibrosis;

    10. In those without biopsy-proven NASH, only, at Pre-Qualification and Visit 1 (Screen 1), meet ≥ 2 of the following 5 criteria for metabolic syndrome:
    • FPG ≥ 100 mg/dL (5.6 mmol/L), or on pharmacological agents with explicit purpose of improving glycemic control;
    • Fasting serum HDL-C < 40 mg/dL (1 mmol/L) for males and < 50 mg/dL (1.3 mmol/L) for females, or on pharmacological agents with explicit purpose to increase HDL-C;
    • Fasting serum triglyceride (TG) ≥ 150 mg/dL (1.7 mmol/L), or on pharmacological agents with explicit purpose to decrease TG;
    • Seated blood pressure (BP) ≥ 130 / 85 mm Hg, or on pharmacological agents with explicit purpose for BP control;
    • Waist circumference ≥ 40 inches (102 cm) for males and ≥ 35 inches (89 cm) for females.
    Please refer to the protocol for inclusion criteria 11 to 13.
    E.4Principal exclusion criteria
    1. Subjects with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a trial involving PF-05221304.

    2. Participation in other studies involving investigational drug(s) within 30-days prior to Visit 1 (Screen 1) and during study participation (ie, up to 2nd Follow-up).

    3. At Pre-Qualification and Visit 1 (Screen 1), history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males [1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor)] within the previous 6 months.

    4. At Pre-Qualification and Visit 1 (Screen 1), a total score of ≥ 8 on the AUDIT questionnaire, indicating harmful or hazardous ethanol consumption.

    5. At Pre-Qualification and Visit 1 (Screen 1), a positive urine drug test for illicit drugs.

    6. At Pre-Qualification and Visit 1 (Screen 1), a persistent severe, uncontrolled
    hypertension; for example: seated systolic blood pressure (SBP) ≥180 mm Hg and/or diastolic blood pressure (DBP) ≥ 105 mm Hg after ≥ 5-minute of rest, with a single repeat permitted to assess eligibility, if needed, at each of these 2 visits:
    • For subjects with SBP ≥ 160 mm Hg or DBP ≥ 100 mm Hg, the Run-in Period must be used to refine the doses of the agents used for management of blood pressure with the aim to have SBP ≤ 159 mm Hg and DBP ≤ 99 mm Hg at the time of randomization;

    7. At Pre-Qualification and Visit 1 (Screen 1), a supine 12-lead ECG demonstrating QTc interval >450 msec or a QRS interval >120 msec:
    • If QTc interval exceeds 450 msec, or QRS interval exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc intervals or QRS intervals should be used to determine the subject’s eligibility.

    8. At Pre-Qualification and Visit 1 (Screen 1), clinical evidence of hepatic decompensation, including, but not limited to esophageal varices, ascites or hepatic encephalopathy.

    9. At Pre-Qualification and Visit 1 (Screen 1), evidence of other forms of chronic liver disease including but not limited to the entities listed below; evidence may include laboratory tests, as assessed by the sponsor-identified central laboratory, with a single repeat permitted to assess eligibility, if needed, at each of those two visit:
    • Hepatitis B virus (HBV), defined by presence of hepatitis B surface antigen (HBsAg);
    • Hepatitis C virus (HCV), defined by presence of hepatitis C antibody (HCVAb) irrespective of HCV RNA result (when reflexed based on a positive result for HCVAb);
    • Human Immunodeficiency Virus (HIV) infection, defined as presence of HIV antibody;
    • Known diagnosis of primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, or overlap syndrome;
    • Alcoholic liver disease, as evaluated via history along with laboratory tests including serum % carbohydrate deficient transferrin result ≥ 1.5x ULN deemed to be highly suggestive to alcohol abuse;
    • History of genetic reason for fatty liver;
    • Wilson's disease, defined as ceruloplasmin level < LLN;
    • Known diagnosis of hemochromatosis;
    • Alpha-1-antitrypsin (A1AT) deficiency, defined as alpha-1-antitrypsin level < LLN;
    • Prior known drug-induced liver injury;
    • Known or suspected Hepatocellular Carcinoma or other liver cancer;
    • History of liver transplant, current placement on a liver transplant list, or current model of end-stage liver disease (MELD) score >12;
    • Histological presence of cirrhosis on prior biopsy.

    10. At Pre-Qualification and Visit 1 (Screen 1), subjects with an estimated glomerular filteration rate (eGFR) of < 30 mL/min using the Modification of Diet in Renal Disease (MDRD) equation, and serum creatinine (SCr), as assessed by the sponsor-identified central laboratory, with a single repeat permitted to assess eligibility, if needed, at each of these 2 visits.
    Please refer to protocol for exclusion criteria 11 to 18.
    E.5 End points
    E.5.1Primary end point(s)
    Percent change from baseline in liver fat, as assessed using MRI-PDFF
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    E.5.2Secondary end point(s)
    - Percent change from baseline in ALT
    - Assessment of TEAEs, safety-related clinical laboratory tests, vital signs, and 12-lead ECGs
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Percent change from baseline in ALT: at Week 16
    - Assessment of TEAEs, safety-related clinical laboratory tests, vital signs, and 12-lead ECGs: at 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 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 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 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 trial5
    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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Australia
    Canada
    Israel
    Poland
    Taiwan
    United States
    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
    End of trial in a Member State of the European Union is defined as the time at which it is deemed that a sufficient number of subjects have been recruited and completed the study as stated in the regulatory application and ethics application in the Member State. Poor recruitment (recruiting less than the anticipated number in the CTA) by a Member State is not a reason for premature termination but is considered a normal conclusion to the study in that Member State.
    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 days14
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days14
    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: 324
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 135
    F.4.2.2In the whole clinical trial 360
    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)
    Medical care beyond the end of the study will be provided for those patients who experience adverse event that are considered related to the study drug. Otherwise, medical care will not be provided after the trial to patients who discontinue dosing of investigational product.
    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 Decision2017-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-26
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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