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    Summary
    EudraCT Number:2018-000192-33
    Sponsor's Protocol Code Number:SB-913-1602
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-04-09
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-000192-33
    A.3Full title of the trial
    A Phase 1/2, Multicenter, Open-label, Single-dose, Dose-ranging Study to Assess the Safety and Tolerability of SB-913, a rAAV2/6-based Gene Transfer in Subjects with Mucopolysaccharidosis II (MPS II)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 1/2 study to evaluate the safety and tolerability of SB-913, a rAAV2/6-based gene therapy in patients with Mucopolysaccharidosis II (MPS II)
    A.4.1Sponsor's protocol code numberSB-913-1602
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03041324
    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 SponsorSangamo Therapeutics, 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 supportSangamo Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSangamo Therapeutics, Inc.
    B.5.2Functional name of contact pointSB-913-1602 Information Desk
    B.5.3 Address:
    B.5.3.1Street Address501 Canal Blvd., Suite A100
    B.5.3.2Town/ cityRichmond CA
    B.5.3.3Post code94804
    B.5.3.4CountryUnited States
    B.5.4Telephone number+15109706000
    B.5.5Fax number+15103237388
    B.5.6E-mailSB9131602-Notification@sangamo.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/3/17/1956
    D.3 Description of the IMP
    D.3.1Product namerAAV2/6 Left ZFN Vector
    D.3.2Product code SB-47171
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet assigned
    D.3.9.1CAS number 2143578-31-6
    D.3.9.2Current sponsor codeSB-47171
    D.3.9.3Other descriptive nameAdeno-associated virus serotype 2/6 encoding Left side-zinc finger nuclease (ZFN1), SB-A6P-ZLEFT Vector
    D.3.10 Strength
    D.3.10.1Concentration unit vector genomes (vg)/mL
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000000000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    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/3/17/1956
    D.3 Description of the IMP
    D.3.1Product namerAAV2/6 Right ZFN Vector
    D.3.2Product code SB-47898
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet assigned
    D.3.9.1CAS number 2143578-32-7
    D.3.9.2Current sponsor codeSB-47898
    D.3.9.3Other descriptive nameAdeno-associated virus serotype 2/6 encoding Right side-zinc finger nuclease (ZFN2), SB-A6P-ZRIGHT Vector
    D.3.10 Strength
    D.3.10.1Concentration unit vector genomes (vg)/mL
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000000000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/17/1956
    D.3 Description of the IMP
    D.3.1Product namerAAV 2/6 hIDS DONOR
    D.3.2Product code hIDS DONOR
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet assigned
    D.3.9.1CAS number 2143580-10-1
    D.3.9.2Current sponsor codeSB-IDS
    D.3.9.3Other descriptive nameAdeno-associated virus serotype 2/6 encoding Human Iduronate 2-sulfatase (hIDS) gene donor vector, SB-A6P-HNT Donor Vector
    D.3.10 Strength
    D.3.10.1Concentration unit vector genomes (vg)/mL
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000000000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    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
    Mucopolysaccharidosis type II (MPS II)
    E.1.1.1Medical condition in easily understood language
    Hunter Syndrome, is a rare, inherited disease caused by a deficiency in an enzyme called iduronate-2-sulfatase. This causes glycosaminoglycans (GAGs) to build up in the body and cause damage.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10056889
    E.1.2Term Mucopolysaccharidosis II
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of SB-913
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    • To evaluate change from Baseline over time in the following assessments:
    o IDS activity in blood.
    o GAG testing in urine.
    o Frequency of ERT administration.
    • AAV2/6 clearance.
    Exploratory Objectives:
    • To evaluate change from Baseline over time in the following assessments:
    o GAG testing in tissues (including blood, liver tissue, and cerebrospinal fluid [CSF]).
    o Gene modification at the albumin locus in the liver.
    o Imaging, functional, and neurocognitive testing related to MPS II.
    o Immune response to AAV 2/6, ZFNs and IDS.
    From consenting subjects, residual samples may be used for future research objectives.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria
    Subjects must meet all of the following criteria to be included in the study:
    1. Signed informed consent.
    2. ≥5 years of age:
    a. Adult cohorts 1 through 4: ≥ 18 years of age;
    b. Pediatric cohorts 5 and 6: 12 to 17 years of age; and
    c. Pediatric cohorts 7 and 8: 5 to 11 years of age.
    3. Clinical diagnosis of MPS II (based on evidence of hepatosplenomegaly, dysostosis multiplex by X-ray, valvular heart disease, or obstructive airway disease); IDS deficiency confirmed by gene sequencing.
    4. Sexually mature subjects must agree to use a barrier contraceptive method for prevention of AAV transfer as follows: for female subjects this means that the subjects’ partners must use a condom from dosing with SB-913 and until at least 3 consecutive plasma samples after administration of SB-913 are negative for AAV2/6; for male subjects this means that the subjects must use a condom and must refrain from sperm donation from the time of SB-913 administration until at least 3 consecutive semen samples after administration of SB-913 are negative for AAV2/6. In addition, female participants of child-bearing potential must consent to use a highly effective method of contraception.
    5. MRI negative for liver mass as read by a radiologist
    E.4Principal exclusion criteria
    Exclusion Criteria
    Subjects who meet any of the following criteria will be excluded from participating in the study
    1. Known to be unresponsive to ERT.
    2. Neutralizing antibodies in serum (immune response) to AAV2/6.
    3. Serious intercurrent illness or clinically significant organic disease (unless secondary to MPS II) such as cardiovascular, hepatic, pulmonary, neurologic, or renal disease.
    4. Receiving antiviral therapy for hepatitis B or C, or with active hepatitis B (HBV DNA positive or HBV surface antigen positive) or hepatitis C (HCV RNA viral load) or human immunodeficiency virus (HIV)-1/2 (HIV RNA viral load or HIV antibody positive); to be considered negative for hepatitis C after treatment of an active HCV infection, viral assays in 2 samples collected at least 6 months apart must be negative.
    5. Lack of tolerance to idursulfase treatment with significant infusion-associated reactions (IARs) or occurrence of anaphylaxis.
    6. Polymorphisms in the ZFN-targeted region of the albumin locus.
    7. Liver fibrosis score of 3 or 4 on a 0 to 4 point scale (Desmet et al. 1994) if subject has had a liver biopsy within 2 years of Screening.
    8. Markers of hepatic dysfunction as evidenced by one or more of the following:
    a) Platelet count <100,000/μL
    b) Albumin ≤3.2 g/dL
    c) Total bilirubin >1.5 x upper limit of normal (ULN) and direct bilirubin ≥0.5 mg/dL
    d) Alkaline phosphatase >2.0 x ULN
    e) ALT or AST >2.0 x ULN
    9. Creatinine ≥ 1.5 mg/dL
    10. Weight < 20 kg at Screening visit.
    11. Pregnant or breastfeeding female.
    12. Contraindication to the use of corticosteroids.
    13. Current treatment with systemic (IV or oral) immunomodulatory agent or steroid use (topical treatment allowed, e.g., for asthma or eczema).
    14. History of active malignancy in past 5 years (non-melanoma skin cancer or cervical cancer in situ permitted).
    15. Participation in prior investigational drug or medical device study within the previous 3 months.
    16. Prior treatment with a gene therapy product.
    17. History of alcohol or substance abuse that in the opinion of the Principal Investigator may interfere with study compliance.
    18. History of therapeutic non-adherence.
    19. Elevated or abnormal circulating AFP.
    20. Any other reason that, in the opinion of the Principal Investigator or Medical Monitor, would render the subject unsuitable for participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint:
    • Incidence of treatment-emergent AEs (including SAEs).
    • Additional safety evaluations include:
    o Routine hematology, chemistry and liver function laboratory tests, vital signs, physical exam, electrocardiogram (ECG), echocardiogram (ECHO), and concomitant medications.
    o Cranial nerve exam and muscle strength testing.
    o Serial α-fetoprotein (AFP) testing and magnetic resonance imaging (MRI) of liver to evaluate for liver mass.
    E.5.1.1Timepoint(s) of evaluation of this end point
    -Liver Panel: Baseline (BL), twice a week (wk) for at least the first 20 wks post infusion, then tested at wk 24, 28, 32, 36, 40, 44, 48, 52, Month 15, 18, 21, 24, 27, 30, 33, 36 & ETV
    -AE assessments and concomitant medications: All time points
    -Clinical Laboratory tests: All time points except day 0, Day 7, wk 28, 32, 40, 44 & 52
    -Vital signs & physical exam: BL, Day 0, Day 1, Day 7, wk 2, 4, 6, 8, 12, 16, 20, 24, 36, 48, Month 15, 18, 21, 24, 27, 30, 33, 36 & ETV
    -ECG, Cranial nerve exam and muscle strength testing: BL, Day 7 (ECG only), wk 24, 48, Month 18, 24, 30, 36 & ETV
    -ECHO: Wk 48, Month 24, 36 & ETV
    -AFP: Wk 4, 8, 12, 24, 48 Month 18, 24, 30, 36 & ETV
    -MRI Liver: Wk 24, 48, Month 18, 24, 30 & 36 & ETV
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    • Change from Baseline in:
    o IDS activity measured in blood.
    o Total GAG, DS GAG, and HS GAG levels (expressed as ratio to creatinine) measured in urine.
    o Monthly and annualized frequency and dose of idursulfase (or equivalent ERT).
    • AAV2/6 clearance measured by vector genomes in plasma, saliva, urine, stool, and semen by PCR.

    Exploratory Endpoints:
    •Change from Baseline in:
    o Total GAG, DS GAG, and HS GAG levels measured in tissues (including blood, liver tissue, and CSF).
    o Percentage and durability of gene modification at the albumin locus in liver tissue obtained at biopsy.
    o Forced vital capacity measured by pulmonary function tests (PFTs)
    o Distance walked measured by six-minute walk test (6MWT).
    o Joint range of motion (JROM).
    o MRI of liver to evaluate liver and spleen volume.
    o MRI of brain and cervical spine to evaluate clinical soft tissue and/or bone
    o Neurocognitive abilities by WASI-II (Wechsler Abbreviated Scale of Intelligence, Second Edition; Shapiro et al. 2015), WPPSI-IV (Wechsler Preschool and Primary Scale of Intelligence), or BSID-III (Bayley Scales of Infant Development), and by VABS-II (Vineland Adaptive Behavior Scales).
    o Histopathological exam of liver tissue.
    o Immune response to AAV 2/6, ZFNs, and IDS measured in serum.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -IDS/GAG testing in blood: Baseline (BL), Wk 2, 4, 6, 8, 12, 16, 20, 24, 36, 48, Month 15, 18, 21, 24, 27, 30, 33, 36 & ETV
    - GAG testing in Urine: BL, Wk 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, Month 15, 18, 21, 24, 27, 30, 33, 36 & ETV
    -AAV2/6 clearance: BL, Day 7, Wk 2, 4, 8, 12, 16, 20, 24, 36, and 48
    -Liver biopsy and Lumbar Puncture: BL, Wk 24, 48
    -PFT and 6MWT: BL, Wk 24, 48, Month 18, 24, 30, 36 & ETV
    -JROM: BL, Wk 24, 48, Month 18, 24, 30, 36 & ETV
    -MRI Liver:Wk 24, 48, Month 18, 24, 30 & 36 & ETV
    -MRI brain and cervical spine: BL, Wk 48, Month 24, 36 & ETV
    -Neurocognitive abilities and VABS-II: BL, Wk 24, 48, Month 18, 24, 30, 36 & ETV
    -AAV and ZFN Immunogenicity: BL, Wk 4, 12, 24, 36, 48, Months 18, 24
    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 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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    The sponsor has treated 6 (Six) adult patients so far under the ongoing US study (BB-IND 17006)
    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.8.3 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 concerned4
    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
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 7
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 7
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 9
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 32
    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)
    Upon completion of this study, subjects will be asked to participate in a separate long-term follow-up study to monitor the long term safety of the study treatment
    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 Decision2018-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-17
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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