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    The EU Clinical Trials Register currently displays   43977   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-003077-15
    Sponsor's Protocol Code Number:EIG-LNF-002
    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:2015-09-02
    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 number2015-003077-15
    A.3Full title of the trial
    A Phase 2, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Activity of Titrating-Dose Lonafarnib in Combination with Ritonavir in Patients Chronically Infected with Hepatitis Delta Virus (LOWR-4)
    Eine offene Phase-2-Studie zur Untersuchung der Sicherheit, Verträglichkeit, Pharmakokinetik und Pharmakodynamik von Lonafarnib (Dosistitration) in Kombination mit Ritonavir bei Patienten mit chronischer Hepatitis Delta Infektion (LOWR-4)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Eine offene Phase-2-Studie zur Untersuchung der Sicherheit, Verträglichkeit, Pharmakokinetik und Pharmakodynamik von Lonafarnib (Dosistitration) in Kombination mit Ritonavir bei Patienten mit chronischer Hepatitis Delta Infektion (LOWR-4)
    A.3.2Name or abbreviated title of the trial where available
    LOWR-4
    A.4.1Sponsor's protocol code numberEIG-LNF-002
    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 SponsorEiger BioPharmaceuticals
    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 supportEiger BioPharmaceuticals
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEiger BioPharmaceuticals
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street Address350 Cambridge Ave, Suite 350
    B.5.3.2Town/ cityPalo Alto
    B.5.3.3Post codeCA 94306
    B.5.3.4CountryUnited States
    B.5.6E-mailEigersafety@eigerbio.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1225
    D.3 Description of the IMP
    D.3.1Product nameLonafarnib
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLonafarnip
    D.3.9.1CAS number 193275-84-2
    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.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1225
    D.3 Description of the IMP
    D.3.1Product nameLonafarnib
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLonafarnip
    D.3.9.1CAS number 193275-84-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Yes
    D.2.1.1.1Trade name Norvir
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Limited
    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.3.1Product nameNorvir
    D.3.2Product code EU/1/96/016/005 - 007
    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 INNRITONAVIR
    D.3.9.1CAS number 155213-67-5
    D.3.9.4EV Substance CodeSUB10342MIG
    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.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 D Virus (HDV) Infection.
    E.1.1.1Medical condition in easily understood language
    Chronic Hepatitis D Infection.
    Chronische Hepatitis D Infektion
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of the study are to
    - Evaluate the safety and tolerability of the following dose-titration regimen of
    lonafarnib in combination with ritonavir over the 24-week Treatment Period:
    * lonafarnib/ritonavir starting at 50 mg bid/100 mg twice daily (bid) and escalated to
    * lonafarnib/ritonavir 75 mg bid/100 mg bid and then to 100 mg bid/100 mg bid as
    tolerated

    - Evaluate the pharmacodynamic activity (change in hepatitis D viral [HDV] load) of
    the dose-titration regimen of lonafarnib in combination with ritonavir over the
    24-week Treatment Period
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate the effect of the dose-titration regimen of lonafarnib/ritonavir on the following:
    - Pharmacokinetics (PK)
    - Change in alanine aminotransferase (ALT) levels
    - Change in hepatitis B virus (HBV) DNA levels

    Exploratory objectives of the study are to evaluate the effects of the dose-titration regimen of
    lonafarnib/ritonavir on immunologic parameters during treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient may be included in this study if he or she meets all of the following criteria:
    1. Willing and able to comply with study procedures and provide written informed consent.
    2. Male or female, 18 to 65 years of age, inclusive.
    3. Has a body mass index (BMI) of ≥18 kg/m2 and has a body weight of ≥45 kg.
    4. Chronic HDV infection documented by a positive HDV antibody (Ab) test of at least 6 months duration and detectable HDV RNA by qPCR at study entry.
    5. Liver biopsy demonstrating evidence of chronic hepatitis.
    If no liver biopsy is available, the patient must be willing to consent to and have no contraindication to liver biopsy. Liver biopsy will be performed during screening.
    6. ALT <10x ULN
    7. Electrocardiogram (ECG) demonstrating no acute ischemia or clinically significant abnormality and a QT interval corrected for heart rate (QTc) of < 450 ms using Fridericia correction (ICH Guidance for Industry E14: Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs).
    8. Females who meet the following criteria may be eligible to enter the study:
    a. Of nonchildbearing potential—defined as women who are surgically sterile (have had bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), have medically documented ovarian failure, or are postmenopausal (amenorrheic for more than 2 years, age appropriate, and confirmed by follicle-stimulating hormone [FSH] level indicating a postmenopausal state).
    b. Of childbearing potential—defined as women who have an intact uterus and ovaries and are within 1 year since the last menstrual period who
    – Are not pregnant and have negative serum pregnancy test at screening and a negative urine pregnancy test on the Baseline/Day 1 Visit before randomization.
    – Are not lactating or breastfeeding.
    – Agree to use two of the following contraceptive methods until at least 90 days after last dose of study drug, of which at least one must be a barrier method:
    - Hormonal contraceptives for at least 3 months before the start of screening and for at least 90 days after last dose of study drug.
    - Intrauterine device (IUD) in place for at least 3 months before the start of screening and until at least 90 days after last dose of study drug.
    - Double-barrier methods (use of condom [male partner] with either diaphragm with spermicide or cervical cap with spermicide) from the start of screening until 90 days after last dose of study drug.
    - Surgical sterilization of the partner (vasectomy for 1 month before the start of screening and, throughout study and for at least 90 days after last dose of study drug).
    9. Males with female partners who are of childbearing potential (see above) who meet the following criteria may be eligible to enter the study:
    a. Are surgically sterile
    or
    b. Agree to practice two effective forms of birth control from those listed below from the start of screening until at least 90 days after their last dose of study drug, at least one of which must be a barrier method:
    – Consistently and correctly use a condom
    and
    – Their partner must agree to use a hormonal contraceptive or a nonhormonal
    barrier method (IUD or diaphragm with spermicide or cervical cap with
    spermicide).
    E.4Principal exclusion criteria
    1. Participation in a trial with or use of any investigational agent within 30 days of
    start of screening
    2. Pregnant or lactating/breastfeeding
    3. Previous use of lonafarnib
    4. Co-infected with HIV or active infection with HCV
    5. Positive results for HIV or HCV Ab at screening. Patients with positive HCV Ab at screening are allowed if they have completed a curative antiviral regimen and are documented to be HCV RNA negative (undetectable) at least 3 months before and at screening
    6. Active jaundice defined by total bilirubin level >2.0 mg/dL and known not to have Gilberts disease
    7. A CPT score of >6-based on screening lab results
    8. Decompensated liver disease or cirrhosis as defined by the presence of any of the following on screening lab tests:
    a. Bilirubin level >2.0 mg/dL
    b. Albumin level <3.0 g/dL
    c. Platelet count <90,000 cells/mm3
    d. International normalized ratio (INR) ≥1.5
    9. History of bleeding esophageal varices, ascites, or hepatic encephalopathy
    10. Patients with any of the following abnormal lab test results at screening:
    a. White blood cell count <3,000 cells/mm3
    b. Absolute neutrophil count <1500 cells/mm3
    c. Hemoglobin <11 g/dL for women and <12 g/dL for men
    d. Abnormal thyroid-stimulating hormone, T4, or T3 levels; unless the patient is stable on thyroid hormone replacement therapy.
    11. Significant renal dysfunction, defined as serum creatinine concentration ≥1.5 times the ULN or an estimated glomerular filtration rate < 80 mL/min at screening, based on the Cockcroft-Gault equation
    12. Evidence of another form of viral hepatitis (not including HBV or HCV) or another form of liver disease
    13. Evidence of hepatocellular carcinoma
    14. Patients with any one of the following:
    a. An eating disorder or alcohol abuse within the past 2 years
    b. Excessive alcohol intake defined as follows: >20 g/day for females (1.5 standard
    alcohol drinks) or >30 g/day for males (2.0 standard alcohol drinks). A standard drink contains 14 g of alcohol: 12 oz of beer, 5 oz of wine, or 1.5 oz of spirits) (1.0 fluid oz [US] = 29.57 mL)
    15. In the opinion of the Investigator, an alcohol use pattern that will interfere with study conduct
    16. Drug abuse within the previous 6 months before the screening visit with the exception of medically prescribed cannabinoids and their derivatives
    17. History or clinical evidence of any of the following:
    a. Immunologically mediated disease that requires more than
    intermittent nonsteroidal anti-inflammatory medications for management or that requires use of systemic corticosteroids in prior 6 months
    b. History of or evidence of retinal disorder or clinically relevant ophthalmic disorder
    c. Any malignancy within 5 years of the start of screening. Exceptions are superficial dermatologic malignancies
    d. Significant or unstable cardiac disease
    e. Chronic pulmonary disease associated with functional impairment
    f. Pancreatitis
    g. Severe or uncontrolled psychiatric disease, incl severe depression, history of
    suicidal ideation, suicidal attempts, or psychosis requiring medication and/or hospitalization
    18. Solid organ transplantation, incl liver
    19. Use of alpha interferon, either interferon alfa-2a or interferon alfa-2b, or pegylated interferon alfa-2a or pegylated interferon alfa-2b within 2 months before the start of screening
    20. Concomitant use of any of the following:
    a. Medications or foods that are known moderate or strong inducers or
    inhibitors of CYP3A4 or CYP2C19
    b. Drugs known to prolong the PR or QT interval unless otherwise
    described in protocol (i.e. Ondansetron).
    c. Receipt of systemic immunosuppressive therapy within the 3 months
    before start of screening.
    d. Statins, due to inhibition of mevalonate synthesis, which reduces protein prenylation
    e. Medications contraindicated in the prescribing information for ritonavir:
    – Alpha1-adrenoreceptor antagonist: alfuzosin HCL
    – Analgesics: pethidine, piroxicam, propoxyphene
    – Antiarrhythmics: amiodarone, flecainide, propafenone, quinidine, bepridil, encainide
    – Antibiotic: fusidic acid
    – Antifungal: voriconazole
    – Antihistamines: astemizole, terfenadine
    – Antimycobacterial: rifabutin
    – Ergot derivatives: dihydroergotamine, ergonovine, ergotamine, methylergonovine
    – Gastrointestinal motility agent: cisapride
    – Herbal products: St. Johns wort (hypericum perforatum)
    – HMG-CoA reductase inhibitors: lovastatin, simvastatin
    – Antipsychotics/Neuroleptic: clozapine, pimozide, quetiapine
    – Phosphodiesterase type 5 enzyme inhibitor: sildenafil only
    when used for the treatment of pulmonary arterial hypertension, avanafil,
    vardenafil
    – Sedative/hypnotics: clorazepate, diazepam, estazolam, flurazepam, oral
    midazolam, triazolam
    f. History or evidence for any intolerance or hypersensitivity to lonafarnib, ritonavir, or other substances that are part of the study medication
    21 . Other significant medical condition that may require intervention during
    the study
    E.5 End points
    E.5.1Primary end point(s)
    The purpose of this study is to evaluate the safety and tolerability of the dose-titration regimen of lonafarnib in combination with ritonavir over the 24-week treatment period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 0 (Day 1), Week 1 (Day 8 ± 2 d), Week 2 (Day 15 ± 2 d), Week 4
    (Day 29 ± 2 d), Week 6 (Day 43 ± 2 d), Week 8 (Day 57 ± 5 d), Week 12 (Day 85 ± 5 d),
    Week 16 (Day 113 ± 5 d), Week 20 (Day 141 ± 5 d), and Week 24 (Day 169 ± 5 d).
    E.5.2Secondary end point(s)
    In addition, the PD activity (ie, change in HDV viral load) of the lonafarnib/ritonavir dose-titration regimen over the 24-week Treatment Period will be evaluated.
    Secondary evaluations will include the effect the lonafarnib/ritonavir dose-titration regimen on
    PK characteristics, ALT levels, and HBV DNA levels. Exploratory evaluations will include the effects of the lonafarnib/ritonavir dose-titration regimen on immunologic parameters during treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 0 (Day 1), Week 1 (Day 8 ± 2 d), Week 2 (Day 15 ± 2 d), Week 4
    (Day 29 ± 2 d), Week 6 (Day 43 ± 2 d), Week 8 (Day 57 ± 5 d), Week 12 (Day 85 ± 5 d),
    Week 16 (Day 113 ± 5 d), Week 20 (Day 141 ± 5 d), and Week 24 (Day 169 ± 5 d).
    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 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 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 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.8.2.4Number of treatment arms in the trial1
    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 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
    LVLS.
    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
    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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 15
    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)
    After a patient has ended his/her participation in the study, his/her medical doctor will offer the most appropriate treatment currently available.
    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 Decision2015-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-26
    P. End of Trial
    P.End of Trial StatusCompleted
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