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    Summary
    EudraCT Number:2016-004129-18
    Sponsor's Protocol Code Number:AK581
    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:2016-12-21
    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 number2016-004129-18
    A.3Full title of the trial
    CONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An extension study on rVA576 (Coversin) for Patients with PNH and aHUS who received benefit from their initial study
    A.4.1Sponsor's protocol code numberAK581
    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 SponsorAkari Therapeutics Plc
    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 supportAkari Therapeutics Plc
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAkari Therapeutics Plc
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street Address75-76 Wimpole Stree
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1G 9RT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441451850128
    B.5.6E-mailwynne.weston-davies@akaritx.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/3/16/1725
    D.3 Description of the IMP
    D.3.2Product code rVA576
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrVA576
    D.3.9.2Current sponsor coderVA576
    D.3.9.3Other descriptive namerVA576
    D.3.9.4EV Substance CodeSUB182098
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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
    Paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS)
    E.1.1.1Medical condition in easily understood language
    Paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10018932
    E.1.2Term Haemolytic uraemic syndrome
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10034042
    E.1.2Term Paroxysmal nocturnal haemoglobinuria
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of the study are:
    1)To observe the long term safety and efficacy of rVA576 (Coversin) over periods in excess of 6 months
    2)To assess the long term patient acceptability of rVA576 (Coversin) using the EORTC QLQ-C30 and the EQ-5D-5L instruments
    3)To observe the changes, if any, in the production of anti-drug antibodies (ADA) and whether such antibodies are, or become, neutralising
    4)To assess the effects, if any, on any changes in formulation or drug delivery that may be introduced during the study period
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Patients 18 years and above successfully treated with rVA576 (Coversin) under other Akari clinical trial protocols and wish to remain
    on rVA576 (Coversin)at the conclusion of that trial.
    2)In the opinion of the treating responsible clinician patient is receiving clinical benefit from continued treatment with study drug.
    3)Evidence of sustained total complement inhibition by CH50 assay.
    4)Women of childbearing potential (WOCBP) must agree to use effective contraception consistently throughout the study and have a negative pregnancy test at screening. Women are considered post-menopausal and not of childbearing potential if they have had 12 months of
    amenorrhea and considered sterile if they have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least
    six weeks previously.
    5)Males with a childbearing potential partner must agree to use effective contraception consistently OR have had a vasectomy.
    6)Weight >50kg .
    7)Received appropriate prophylaxis against Neisseria meningitidis infection, by both immunisation and continuous or intermittent antibiotics
    8)Patient is willing to give voluntary written informed consent.
    9)The patient is willing in the process of preparation and self administration of the study drug.
    E.4Principal exclusion criteria
    1)Patient experienced any safety event in the previous study protocol, which puts the patient at unacceptable risk in the current protocol in the clinical judgement of the investigator and sponsor.
    2)Patient is unwilling to complete the Quaity of Life instruments and diary card.
    3)Active meningococcal infection (section 4.3.2 for additional information).
    4)Any other reason for which, in the opinion of the investigator, it would not be in the interests of the patient to remain on rVA576 (Coversin).
    5)If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 90 days after last dose; or intending
    to donate ova during such period.
    6)If male, the subject intends to donate sperm during this study or for 90 days after last dose.
    7)Failure to satisfy the Investigator of fitness to participate for any reason or any condition which, in the opinion of the investigator, could increase the subject's risk from participating in the study or confound the outcome of the study.
    8)Use of prohibited medication (e.g. eculizumab (Soliris®), Chemotherapeutic agents, any other drug acting directly on the complement system).
    9)The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within one year prior to screening.
    10)Participation in other clinical trials with investigational product.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoints:
    Long term safety of rVA576 (Coversin) as assessed by SAEs, AEs, vital signs, immunogenicity assessments, results of appropriate standard laboratory tests (clinical chemistry, haematology, coagulation, urinalysis, and ADA).
    E.5.1.1Timepoint(s) of evaluation of this end point
    3, 6, 9, 12 months and every 6 monthly thereafter until the end of the study
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    1)Thrombotic and haemolytic event free survival at 3, 6, 9 and 12months and 6 monthly thereafter from the start of the long term safety and efficacy study.
    2)Reduction in requirement for blood or blood product transfusion compared to pre-rVA576 (Coversin) treatment over a similar period if data are available (for complement inhibitor naïve patients).
    3)Reduction in requirement for blood or blood product transfusion compared to pre-rVA576 (Coversin) treatment over a similar period (for patients who received treatment with another complement inhibitor before switching to rVA576 (Coversin).
    4)Non-inferiority in requirement for blood or blood product transfusion compared to pre-rVA576 (Coversin) treatment over a similar period for patients who received treatment with another complement inhibitor before switching to rVA576 (Coversin). For example there should be no increase in transfusion requests for 3 months post-switch compared to 3 months pre-switch.
    5)Quality of life using the EORTC QLQ-C30 and the EQ-5D-5L instruments at 3, 6, 9 and12 months and at each clinic visit thereafter.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6, 9, 12 months and 6 monthly thereafter until the end of the study
    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 No
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Argentina
    France
    Germany
    Kazakhstan
    Netherlands
    Poland
    Sri Lanka
    United Kingdom
    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
    LSLV
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 50
    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)
    Patients for whom rVA576 (Coversin) was found to be effective in this clinical trial and who wish to continue on the drug following conclusion of this trial, will continue to receive rVA576 (Coversin), until rVA576 (Coversin) receives marketing approval in the country or another treatment of benefit becomes available. If Akari encounters issues with availability of the drug, it will allocate available drug to such patients in a manner which is fair and consistent with ethical requirements.
    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 Decision2017-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-06-22
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