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    Summary
    EudraCT Number:2018-002751-15
    Sponsor's Protocol Code Number:ST-001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-09-19
    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 number2018-002751-15
    A.3Full title of the trial
    A Phase 3, Intravenous Sodium Thiosulfate for Acute Calciphylaxis Treatment: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the use of sodium thiosulfate for the treatment of patients with calciphylaxis (accumulation of calcium in small blood vessels of the fat and skin tissues)
    A.4.1Sponsor's protocol code numberST-001
    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 SponsorHope Pharmaceuticals 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 supportHope Pharmaceuticals Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHope Pharmaceuticals Ltd
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street Address120 Baker Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1U 6TU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442033188112
    B.5.6E-mailquestions@hopepharm.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 Sodium Thiosulfate 250 mg/mL Solution for Injection
    D.2.1.1.2Name of the Marketing Authorisation holderHope Pharmaceuticals Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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/3/14/1414
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    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 INNSodium Thiosulfate
    D.3.9.1CAS number 7772-98-7
    D.3.9.3Other descriptive nameSODIUM THIOSULFATE
    D.3.9.4EV Substance CodeSUB15332MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Calciphylaxis
    E.1.1.1Medical condition in easily understood language
    accumulation of calcium in small blood vessels of the fat and skin tissues
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10051714
    E.1.2Term Calciphylaxis
    E.1.2System Organ Class 10027433 - Metabolism and nutrition 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 compare the effects of treatment with intravenous Sodium Thiosulfate Injection vs. placebo for the proportion of patients (responders) who achieve a greater than or equal to 30% mean reduction from the last 24 hours of the 72 hour run-in phase prior to initiation of study drug in pain intensity score for the worst non-evoked pain intensity score calculated from the daily pain diaries (modified BPI/SF) over the last two days (averaged over Day 20 and Day 21) of the 3-week double-blind treatment phase in adult patients with end-stage renal disease on chronic haemodialysis.
    E.2.2Secondary objectives of the trial
    To compare the effects of treatment with intravenous Sodium Thiosulfate Injection vs. placebo on:
    - Proportion of patients who achieve improvement or stabilisation (i.e. not worsening) of index lesion at the end of the 3-week double-blind treatment phase on Day 21 based upon clinical assessment compared to the clinical assessment during run-in phase.
    -Occurrence of surgical debridement of skin lesions and/or amputation over the third week of the 3-week double-blind treatment phase.
    -Occurrence of surgical debridement of skin lesions and/or amputation over the 3-week double-blind treatment phase.
    -Time in days to when patient achieves a greater than or equal to 30% mean reduction from the last 24 hours of the 72 hour run-in phase prior to initiation of study drug in pain intensity score for the worst non-evoked pain intensity score calculated from the daily pain diaries (modified BPI/SF)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Informed of the investigational nature of the study and sign written informed consent
    -Willing and able to adhere to all study-related procedures, including adherence to study medication regimen
    -Male or female 18 years old and over
    -End-stage renal disease on chronic haemodialysis
    -Calciphylaxis with active skin lesions(s) of any morphological appearance (including but not limited to livedo, induration, ulceration etc.) and tissue histology review consistent with calciphylaxis diagnosis. Histological features consistent with calciphylaxis will include soft tissue calcification, microthrombosis and/or fibrointimal hyperplasia of dermal arterioles.
    -Acute pain associated with calciphylaxis lesions with the worst non-evoked pain intensity score of greater than or equal to 5 at initial screening on the modified BPI/SF scale and for both of the 2 days preceding randomisation with the mean of the two scores greater than or equal to 6
    -Females of childbearing potential must have a pregnancy test (urine or serum [if anuric]) at screening and not be pregnant and willing to use an acceptable method of contraception from screening through the last study visit (4 weeks): hormonal (oral pills, implant or injection) begun at time of screening, barrier (condom, diaphragm or cervical cap with spermicide), intrauterine device (IUD), abstinence (not having sex), being with the same sex partner or a partner who has had a vasectomy at least six months before the screening visit
    E.4Principal exclusion criteria
    -Peritoneal dialysis patients
    -Current congestive heart failure exacerbation
    -Baseline abnormalities related to QT prolongation (corrected QT interval >490 ms) or history of Torsade de Pointes, hypocalcaemia (serum albumin-corrected calcium < 8 mg/dL), metabolic acidosis (serum bicarbonate < 18 mmol/L), hypotension (resting systolic blood pressure while seated < 80) or interdialytic weight gain greater than or equal to 4% of body weight for patients whose body weight is over 100 kg.
    -History of ventricular arrhythmias including ventricular fibrillation or ventricular tachycardia associated with shortness of breath, dizziness, hypotension or syncope
    -Any prior (within the past 30 days) from the start of the screening visit or current intravenous Sodium Thiosulfate Injection treatment
    -Other investigational agent (drug, biologic or device) study within the past 30 days from the start of the screening visit and/or for the duration of the trial
    -Pregnant or lactating women
    -History of allergy to sulfites, thiosulfate or any component in Sodium Thiosulfate Injection (sulfa allergy is not an exclusion criterion)
    -Significant other acute or chronic concomitant diseases (including but not limited to hepatic, cardiovascular, pulmonary or oncologic disease, sepsis, pulmonary oedema, pulmonary embolism) that would be inconsistent with survival for at least 3 months from screening visit
    -Other serious concurrent or recent medical or psychiatric condition which, in the opinion of the Investigator, makes the patient unsuitable for participation in this study
    -Ongoing application of dialysate admixed with iron salt e.g. ferric pyrophosphate during the entire trial period (patients who are on dialysate admixed with iron salt at screening are eligible if dialysate admixed with iron salt can be substituted with non-iron based dialysate and patients can be maintained on non-iron based dialysate therapy for the entire duration of trial period)
    -Recent (within 1 week from the start of the screening visit) history of surgical parathyroidectomy or scheduled for surgical parathyroidectomy during the course of the study
    -History of opioid addiction
    -Significant clinical improvement by day 0 defined as > 50% improvement in the worst non-evoked pain intensity score in the preceding 24 hour period of run-in phase or > 50% improvement in skin lesions during the run-in phase as determined by clinical investigator

    E.5 End points
    E.5.1Primary end point(s)
    1. The proportion of patients (responders) who achieve a greater than or equal 30% mean reduction from the last 24 hours of the 72 hour run-in period prior to initiation of study drug in pain intensity score for the worst non-evoked pain intensity score calculated from the daily pain diaries (modified BPI/SF) over the last two days (averaged over Day 20 and Day 21) for the 3-week double-blind treatment phase.
    Responder from the daily pain intensity dairy scores is calculated as follows: (Yi/yi0 ≤ -0.3)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. The last two days (averaged over Day 20 and Day 21) of the 3-week double-blind treatment phase
    E.5.2Secondary end point(s)
    1. Proportion of patients who achieve improvement or stabilisation (i.e. not worsening) of index lesion at the end of the 3-week double-blind treatment phase on Day 21 based upon clinical assessment compared to the clinical assessment during run-in phase
    2. Occurrence of surgical debridement of skin lesions and/or amputation during the third week of the 3-week double-blind treatment phase
    3. Occurrence of surgical debridement of skin lesions and/or amputation over the 3-week double-blind treatment phase
    4. Time in days to when a patient achieves a greater than or equal to 30% mean reduction from the last 24 hours of the 72 hour run-in phase prior to initiation of study drug in pain intensity score for the worst non-evoked pain intensity score calculated from the daily pain diaries (modified BPI/SF) in patients who are classified as responders at endpoint
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 21 of the 3-week double-blind treatment phase
    2. Over the third week of the 3-week double-blind treatment phase
    3. Over the 3-week double-blind treatment phase
    4. At the end of the 3-week double-blind treatment phase
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned14
    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
    Australia
    Canada
    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 years2
    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 years2
    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.1.3Elderly (>=65 years) Yes
    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 state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 111
    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)
    Subjects offered participation in follow-up 8-week observational study ST-003.
    Subjects are also followed by their local nephrologists after completion of study ST-001.
    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 Decision2018-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-04-15
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