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    Summary
    EudraCT Number:2016-000276-23
    Sponsor's Protocol Code Number:201464
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-11
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-000276-23
    A.3Full title of the trial
    A multiple treatment session, open label phase 2 clinical study of
    GSK2398852 administered following and together with
    GSK2315698 in cohorts of patients with cardiac amyloidosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to look at the affect of anti-SAP treatment in patients with cardiac amyloidosis
    A.4.1Sponsor's protocol code number201464
    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 SponsorGlaxoSmithKline Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research & Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street Address1-3 Iron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 0800 783 9733
    B.5.5Fax numberNot Applicable
    B.5.6E-mailGSKClinicalSupportHD@gsk.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/3/14/1292
    D.3 Description of the IMP
    D.3.1Product nameGSK2315698
    D.3.2Product code GSK2315698
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmiridesap
    D.3.9.1CAS number 224624-80-A
    D.3.9.2Current sponsor codeGSK2315698
    D.3.9.3Other descriptive nameCPHC (carboxy pyrrolidine hexanoyl pyrrolidone carboxylate)
    D.3.9.4EV Substance CodeSUB73041
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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/3/14/1293
    D.3 Description of the IMP
    D.3.1Product nameGSK2398852
    D.3.2Product code GSK2398852
    D.3.4Pharmaceutical form Concentrate for 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 INNdezamizumab
    D.3.9.2Current sponsor codeGSK2398852
    D.3.9.4EV Substance CodeSUB79723
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Systemic amyloidosis
    E.1.1.1Medical condition in easily understood language
    Systemic amyloidosis
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10021428
    E.1.2Term Immune system disorders
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002022
    E.1.2Term Amyloidosis
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -Assessment of reduction in cardiac
    amyloid load after repeated administrations
    of Anti-SAP treatment as evaluated by
    CMR in all study groups

    -Assessment of safety & tolerability of
    repeated administration of Anti-SAP
    treatment, including compatibility with
    chemotherapy treatment in Group 3.
    E.2.2Secondary objectives of the trial
    -Investigation of rash associated with Anti-
    SAP treatment.

    -Characterisation of the pharmacokinetics
    of anti-SAP mAb.

    -Assessment of changes in circulating markers associated with pharmacodynamic
    effect during repeated administrations.

    -Evaluation of changes in imaging markers of cardiac dysfunction monitored by serial CMR and / or ECHO.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in this study only if all of the following criteria apply:

    AGE
    1. Between 18 and 80 years of age inclusive, at the time of signing the informed consent.

    SEX
    2. Gender: Male and female.
    Males:
    Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication for a cycle of spermatogenesis following five terminal half-lives after the last dose of study medication.
    a. Vasectomy with documentation of azoospermia.
    b. Male condom plus partner use of one of the contraceptive options below:
    -Contraceptive subdermal implant
    -Intrauterine device or intrauterine system
    -Combined Oral Contraceptive or Injectable progestogen
    -Contraceptive vaginal ring
    -Percutaneous contraceptive patches

    This is an all-inclusive list of those methods that meet the following GSK definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. For non-product methods (e.g., male sterility), the investigator determines what is consistent and correct use. The GSK definition is based on the definition provided by the ICH.

    The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.

    Females
    A female subject is eligible to participate if she is not pregnant, not lactating, and at least one of the following conditions applies:
    a.Non-reproductive potential defined as:
    -Pre-menopausal females with one of the following:
    -Documented tubal ligation
    -Documented hysteroscopic tubal occlusion procedure with follow-up
    -confirmation of bilateral tubal occlusion
    -Hysterectomy
    -Documented Bilateral Oophorectomy
    -Postmenopausal defined as:
    >or= 60 years old
    Twelve (12) months of spontaneous amenorrhea with an appropriate clinical profile, e.g. age appropriate, > 45 years, in the absence of hormone replacement therapy (HRT) or medical suppression of the menstrual cycle (e.g. leuprolide treatment) in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and oestradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels). Females on HRT and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.

    b. Reproductive potential and agrees to follow one of the options listed in the Modified
    List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) (see Appendix 7) from 30 days prior to the first dose of study medication and until 3 months after the last dose of study medication.

    The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception

    INFORMED CONSENT
    3. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

    OTHER
    4. Late-Gadolinum enhancement (LGE) on CMR indicative of cardiac amyloidosis


    Inclusion Criteria for Group 1
    TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
    5. ATTR cardiomyopathy (ATTR-CM)
    a) Subjects with a diagnosis of hereditary ATTR amyloidosis should have a known
    amyloidogenic TTR mutation demonstrated by genotyping AND is recognised to
    be primarily associated with cardiomyopathy AND one of the following:

    Definite histochemical identification of amyloid by Congo red staining and green
    birefringence in crossed polarised light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis.
    OR
    Scintigraphy: 99mTc-DPD with Grade 2 cardiac uptake or 99mTc-PYP with either Grade 2 or 3 cardiac uptake.

    b) Subjects with a diagnosis of wild type ATTR-CM must be negative by genotyping
    AND have one of the following:
    Definite histochemical identification of amyloid by Congo red staining and green
    birefringence in crossed polarised light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis
    OR
    Scintigraphy 99mTc-DPD with Grade 2 cardiac uptake or 99mTc-PYP with Grade 2 or 3 cardiac uptake.

    6. LVmass on CMR >200g

    7. Clinically stable in New York heart association (NYHA) class 2 or 3 for the 3 months preceding screening

    Inclusion Criteria for Group 2 and 3
    LVmass on CMR >150g; for all other criteria refer to Protocol page 46.
    E.4Principal exclusion criteria
    CONCURRENT CONDITIONS/MEDICAL HISTORY (INCLUDES LIVER FUNCTION AND QTc INTERVAL)
    1. Cardiomyopathy primarily caused by non-amyloid diseases

    2. Interval from the Q wave on the ECG to point T using Fredericia's formula
    (QTcF) > 500 msec

    3. Sustained / symptomatic monomorphic ventricular tachycardia (VT), or rapid polymorphic VT, at screening

    4. Unstable heart failure defined as emergency hospitalization for worsening, or decompensated heart failure, or syncopal episode within 1 month of screening.

    5. Implantable cardiac defibrillator (ICD) or permanent pacemaker (PPM) at screening

    6. NT-proBNP >8500ng/L

    7. Glomerular filtration rate (GFR) at Screening < 40 mL/min

    8. Any active and persistent dermatological condition

    9. Existing diagnosis of any type of dementia

    10. History of allogeneic stem cell transplantation, prior solid organ transplant, or anticipated to undergo solid organ transplantation, or left ventricular assist device (LVAD) implantation, during the course of the study.

    11. Malignancy within last 5 years, except for basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has been successfully treated.

    12. Acute coronary syndrome, or any form of coronary revascularization procedure, within 6 months of screening.

    13. Stroke within 6 months of screening, or transient ischaemic attack (TIA) within 3 months of screening

    14. Symptomatic, clinically significant autonomic neuropathy which the Principal Investigator (PI) feels will preclude administration of study treatment

    15. Hypoalbuminaemia (serum albumin < 30 g/L)

    16. Uncontrolled hypertension during screening

    17. Alanine transaminase ALT >3x upper limit of normal (ULN) AND bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)

    18. Peripheral oedema at Screening that in the opinion of the PI or designee might prevent adequate absorption of subcutaneously administered CPHPC

    19. Urine dipstick positive (>1+) for blood during screening with investigation indicating glomerular haematuria. If other causes are identified, subjects may be enrolled on resolution of the abnormality

    20. Presence of any co-morbid or an uncontrolled medical condition (e.g. diabetes mellitus), which in the opinion of the investigator would increase the potential risk to the subject. Investigator should liaise with the Medical Monitor where there is uncertainty as to the eligibility of a patient

    21. Positive test for hepatitis B hepatitis C, and / or human immunodeficiency virus (HIV) during screening, or within 3 months prior to first dose of study treatment

    22. Unwillingness or inability to follow the procedures outlined in the protocol

    CONCOMITANT MEDICATIONS
    23. Use of GSK2315698 (CPHPC), or participation in a separate clinical trial involving CPHPC within 3 months of screening

    24. Any prohibited concomitant medication as per Section 6.10.2 within 28 days of screening

    DIAGNOSTIC ASSESSMENTS AND OTHER CRITERIA
    25. Donation of blood or blood products in excess of 500 mL within 84 days of screening

    26. Lactating females

    27. Poor or unsuitable venous access

    OTHER
    28. Treatment with another investigational drug, biological agent, or device within
    6 months of screening, or 5 half-lives of the study agent, whichever is longer.

    CONTRAINDICATIONS
    29. History of sensitivity to any of the study medications, or metabolite thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation

    CARDIAC MAGNETIC RESONANCE (CMR) SCANNING
    30. Orthopnoea of sufficient severity to preclude supine scanning as determined at screening

    31. Contraindication to MRI contrast agents

    32. Inability to fit inside scanner due to body size (girth)

    33. Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes but is not limited to:
    a. Intracranial aneurysm clips (except Sugita) or other metallic objects
    b. Intra- orbital metal fragments that have not been removed
    c. Pacemakers or other implanted cardiac rhythm management/monitoring devices and non-MR conditional heart valves
    d. Inner ear implants
    e. History of claustrophobia

    99mTC-PYP OR 99mTC-DPD BONE TRACER RADIOSCINTOGRAPHY
    34. Orthopnoea of sufficient severity to preclude supine scanning as determined at
    Screening

    35. Previous allergic reaction to radioisotope bone tracers

    36. Previous inclusion in a research protocol involving nuclear medicine, positron emission tomography (PET) or radiological investigations with significant radiation burden.

    Refer to protocol page 49 for the following:
    -Exclusion Criteria for Group 1
    -Exclusion criteria for Group 2
    -Exclusion criteria for Group 3
    E.5 End points
    E.5.1Primary end point(s)
    -Change in LV mass over time from baseline to 8-week follow-up

    -Clinical safety data from adverse events (AEs), clinical laboratory tests, vital signs, 12-lead electrocardiogram (ECG), cardiac monitoring and ECHO to 8-week follow-up
    Incidence and grading of skin rashes classified using the Common Terminology Criteria for Adverse Events (CTCAE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    ECHO – Baseline/Sessions 1-6/8-week follow-up

    Adverse events - Monitored throughout the study
    Clinical lab tests – Baseline/Sessions 1-6 ( in patient daily and outpatient days 17 and 24)/All follow-ups
    Vital signs - Baseline/Sessions 1-6 ( in patient days 1-6, day 9 and day 11 and out patient days 17 and 24)/Follow-ups
    12 lead ECG - Baseline/Sessions 1-6 ( in patient daily and out patient days 17 and 24)/Follow-ups
    Cardiac monitoring/ECHO – Baseline/Sessions 1-6/Follow ups
    Incidence and grading of rash - Monitored throughout the study
    E.5.2Secondary end point(s)
    Histopathological & immunohistochemical examination of skin biopsies + blood biomarkers (as data permit)

    Descriptive pharmacokinetic (PK) parameters including the maximum concentration (Cmax), the time associated with Cmax (tmax), and the area under the concentration-time profile (AUC).

    Circulating biomarkers including but not limited to complement pathway components, acute phase proteins (e.g. CRP, SAA) and cytokines (e.g. IL6, IL8, IL10, TNF?).

    Change in cardiac functional measures, including, but not limited to strain (e.g. global longitudinal strain [GLS]), LV twist, stroke volume (SV), ejection fraction (EF), end diastolic volume (EDV) & E/e’ ratio over time from baseline to 8 week follow-up
    E.5.2.1Timepoint(s) of evaluation of this end point
    Skin biopsy & blood sample - Monitored throughout the study
    PK – Sessions 1-6/Day 17/Day 24
    Blood biomarkers – Baseline/ Sessions 1-6/Day 17/Day 24
    MRI & ECHO - Baseline/Sessions 1-6/Follow ups
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open 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 trial3
    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 concerned3
    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 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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 30
    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)
    The investigator is responsible for ensuring that consideration has been given to the poststudy
    care of the subject’s medical condition, whether or not GSK is providing specific post-study treatment.

    Given the lack information about the safety and efficacy of Anti-SAP treatment in AL and ATTR-CM, treatment will not be provided after the end of the study. This may be reviewed once more information is available.
    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 Decision2016-08-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-03
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