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    Summary
    EudraCT Number:2015-003006-16
    Sponsor's Protocol Code Number:5172-079
    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:2017-10-09
    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 number2015-003006-16
    A.3Full title of the trial
    A Phase IIb Clinical Study to Assess the Pharmacokinetics, Safety, and Efficacy of the Combination Regimen of Elbasvir (EBR)/Grazoprevir (GZR) in Participants Aged 3 to less than 18 Years with Chronic Hepatitis C Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Combination Regimen of Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants with Chronic Hepatitis C Infection
    A.3.2Name or abbreviated title of the trial where available
    The Combination Regimen of EBR/GZR in Pediatric Participants with Chronic Hepatitis C Infection
    A.4.1Sponsor's protocol code number5172-079
    A.5.4Other Identifiers
    Name:IND NumberNumber:110,261
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/255/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointGCTO
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive
    B.5.3.2Town/ cityWhitehouse Station, New Jersey
    B.5.3.4CountryUnited States
    B.5.6E-mailBarbara.Haber@merck.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 Yes
    D.2.1.1.1Trade name ZEPATIER
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Film-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 INNELBASVIR
    D.3.9.1CAS number 1370468-36-2
    D.3.9.2Current sponsor codeMK-8742
    D.3.9.3Other descriptive nameELBASVIR, EBR
    D.3.9.4EV Substance CodeSUB174125
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGRAZOPREVIR
    D.3.9.1CAS number 1350514-68-9
    D.3.9.2Current sponsor code MK-5172
    D.3.9.3Other descriptive nameGRAZOPREVIR, GZR
    D.3.9.4EV Substance CodeSUB174126
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.3.1Product nameElbasvir
    D.3.2Product code EBR, MK-8742
    D.3.4Pharmaceutical form Granules
    D.3.4.1Specific paediatric formulation Yes
    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 INNELBASVIR
    D.3.9.1CAS number 1370468-36-2
    D.3.9.2Current sponsor codeMK-8742
    D.3.9.3Other descriptive nameELBASVIR
    D.3.9.4EV Substance CodeSUB174125
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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.3.1Product nameGrazoprevir
    D.3.2Product code GZR, MK-5172
    D.3.4Pharmaceutical form Granules
    D.3.4.1Specific paediatric formulation Yes
    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 INNGRAZOPREVIR
    D.3.9.1CAS number 1350514-68-9
    D.3.9.2Current sponsor codeMK-5172, GZR
    D.3.9.3Other descriptive nameGRAZOPREVIR
    D.3.9.4EV Substance CodeSUB174126
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Chronic genotype 1 or genotype 4 Hepatitis C Virus infection
    E.1.1.1Medical condition in easily understood language
    Chronic genotype 1 or genotype 4 Hepatitis C Virus 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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10047457
    E.1.2Term Viral hepatitis C
    E.1.2System Organ Class 100000004862
    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 steadystate EBR and GZR PK in children and adolescents grouped by age.
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety and tolerability of 12 weeks of treatment with EBR/GZR in children and adolescents grouped by age.
    2. To evaluate the efficacy of 12 weeks of treatment with EBR/GZR in children and adolescents grouped by age, as assessed by the proportion of participants achieving SVR12.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial if the subject consents to participate in this research. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of
    collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    E.3Principal inclusion criteria
    1. The participant has HCV RNA (≥1,000 IU/mL in peripheral blood) at the time of screening.
    2. The participant has documented chronic HCV GT1 or GT4 infection as follows:
    a) positive for anti-HCV antibody, HCV RNA, or HCV GT1 or GT4 at least 6 months before Day 1; or
    b) positive for anti-HCV antibody or HCV RNA with a liver biopsy consistent with chronic HCV infection (such as the presence of fibrosis) before Day 1.
    3. For participants with GT4, HCV RNA <800,000 IU/mL at the time of screening.
    4. For participants with GT1a, no evidence of NS5A RASs detected at screening at positions 28, 30, 31, and/or 93.
    5. The participant has liver disease staging assessment as follows:
    a) Absence of cirrhosis (F0 to F3) defined as any one of the following:
    i. Liver biopsy performed within 24 months of Day 1 showing absence of cirrhosis, or
    ii. FibroScan® performed within 12 months of Day 1 with a result ≤12.5 kPa (only for participants aged 12 years up to 18 years), or
    iii. In the absence of criterion i. or ii. above, absence of cirrhosis can be determined by the investigator according to local clinical standards that includes physical examination during screening in combination with laboratory evaluation during screening and/or imaging test within 6 months of screening.
    b) Compensated Cirrhosis (F4) defined as any one of the following:
    i. Liver biopsy performed prior to Day 1 showing cirrhosis, or
    ii. FibroScan® performed within 12 months of Day 1 with a result >12.5 kPa (only for participants aged 12 years up to 18 years), or
    iii. In the absence of criterion i. or ii. above, cirrhosis can be determined by the investigator according to local clinical standards that includes physical examination during screening in combination with historical or current laboratory evaluation and/or imaging with findings
    6. The participant has an HCV treatment status that is one of the following:
    a) GT1 and GT4: HCV TN (defined as no prior exposure to any interferon [IFN]-containing regimen, RBV, or other HCV-specific DAA agent).
    b) GT1 only: HCV TE (defined as prior virologic failure during or after treatment with an IFN or pegylated-IFN with or without RBV; or intolerance to IFN or pegylated-IFN with or without RBV). Participants cannot have previously received treatment with HCV specific DAA agents.
    7. The participant is male or female between 3 years to less than 18 years of age on day of signing informed consent/assent.
    8. For participants in the Mini Age Cohorts only (these restrictions do not apply for the Expanded Age Cohorts):
    a) Weight:
    i. Age Cohort 1: ≥32 kg
    ii. Age Cohort 2: ≥19 kg
    iii. Age Cohort 3: ≥12 kg
    a) Race: Participants of non-Asian Race.
    9. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
    a.) Not a woman of childbearing potential (WOCBP) as defined in the protocol OR
    b.) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 14 days after the last dose of study treatment.
    10. The participant’s legally acceptable representative(s) provides written informed consent for the study and, when applicable, the participant provides written informed assent.
    11. The participant must be able to swallow the placebo to EBR/GZR (FDC) prior to allocation. This is applicable only to participants in Mini Age Cohort 1 and, if it is determined by PK analysis that Expanded Age Cohort 1 will also receive the adult FDC dose, to participants in Expanded Age Cohort 1.
    E.4Principal exclusion criteria
    1. The participant has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy, or other signs or symptoms of advanced liver disease.
    2. The participant is cirrhotic AND has a Child-Turcotte-Pugh score >6, corresponding to a Child Class B or C.
    3. The participant is co-infected with HIV.
    4. Has evidence of past or present hepatitis B infection (either hepatitis B core antibody [anti-HBc] positive and/or hepatitis B surface antigen [HBsAg] positive) at screening.
    5. The participant has a history of malignancy ≤5 years prior to signing informed consent or is under evaluation for other active or suspected malignancy including HCC.
    6. A WOCBP is expecting to conceive or donate eggs from Day 1 through at least 14 days after the last dose of study treatment or longer if dictated by local regulations.
    7. The participant has any of the following conditions:
    a) organ transplants (including hematopoietic stem cell transplants) other than cornea and hair.
    b) poor venous access that precludes routine peripheral blood sampling required for this study.
    c) history of gastric surgery (eg, stapling, bypass) or malabsorption disorders (eg, uncontrolled celiac sprue disease).
    d) any clinically significant cardiac abnormalities/dysfunction that may interfere with participant treatment, assessment, or compliance with the protocol, including but not limited to: unstable angina, unstable congestive heart failure, unstable arrhythmia; participants currently under evaluation for a potentially clinically significant cardiac abnormality/dysfunction are also excluded.
    e) any major medical condition, clinically significant illness (other than HCV), pre study laboratory or electrocardiogram (ECG) abnormality, or history of any illness, including failure to thrive, which, in the opinion of the investigator, might interfere with participant treatment, assessment, compliance with the protocol, or confound the results of the study or pose additional risk in administering the study drug to the participant.
    f) history of a medical/surgical condition that resulted in hospitalization within the 3 months prior to enrollment, other than for minor elective procedures.
    g) medical/surgical conditions that may result in a need for hospitalization during the study duration.
    h) any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor antagonists, or other immunosuppressant drugs through FW24.
    i) life-threatening serious adverse event (SAE) during the screening period.
    j) Evidence of history of chronic hepatitis not caused by HCV, including but not limited to, drug-induced hepatitis, hemochromatosis, Wilson’s disease, α1 antitrypsin deficiency, alcoholic liver disease, and autoimmune hepatitis.
    8. A WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study treatment. If the urine test cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
    9. The participant is taking or plans to take any of the prohibited medications listed in the protocol or is taking herbal supplements, including but not limited to St. John’s Wort (Hypericum perforatum), from 2 weeksprior to Day 1 through 2 weeks after the study treatment period.
    10. The participant has had previous HCV DAA treatment.
    11. The participant is currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent/assent and is not willing to refrain from participating in another such study through 24 weeks after the study treatment period (FW24).
    12. The participant has exclusionary laboratory values at the screening visit as listed in the protocol.
    13. The participant has significant emotional problems or a clinically significant psychiatric disorder that may interfere with participant treatment, assessment, or compliance with the protocol.
    14. The participant has clinically relevant drug or alcohol abuse within 12 months of screening that may interfere with participant treatment, assessment, or compliance with the protocol.
    15. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this study.
    E.5 End points
    E.5.1Primary end point(s)
    Week 4 AUC0-24, maximum observed drug concentration (Cmax), drug concentration immediately pre-dose (Ctrough), and apparent clearance (CL/F).).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment Week 4
    E.5.2Secondary end point(s)
    1. Number of participants experiencing AEs.
    2. Number of participants discontinuing study drug due to AEs.
    3. SVR12: defined as HCV RNA <lower limit of quantification (LLOQ) (either target detected, but unquantifiable [TD(u)] or target not detected [TND]) 12 weeks after the end of all study therapy.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks after treatment completion
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    multiple cohorts
    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 trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Poland
    Sweden
    United States
    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
    The overall study ends when the last participant completes the last study-related phone-call or visit, withdraws from the study or is lost to follow-up (ie, the participant is unable to be contacted by the investigator)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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 Yes
    F.1.1Number of subjects for this age range: 56
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 34
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 22
    F.1.2Adults (18-64 years) No
    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 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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 33
    F.4.2.2In the whole clinical trial 56
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation DrugDev TrialNetworks
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-23
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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