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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7259   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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    EudraCT Number:2015-003778-34
    Sponsor's Protocol Code Number:VIP578
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-10
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-003778-34
    A.3Full title of the trial
    Coversin in Paroxysmal Nocturnal Haemoglobulinuria (PNH) in patients with resistance to Eculizumab due to complement C5 Polymorphisms
    Coversin bij Paroxysmale Nachtelijke Hemoglobinurie (PNH) bij patienten die resistent zijn voor Eculizumab als gevolg van een C5 polymorfisme
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Coversin in Paroxysmal Nocturnal Haemoglobulinuria (PNH) in patients with resistance to Eculizumab due to complement C5 Polymorphisms
    Coversin bij Paroxysmale Nachtelijke Hemoglobinurie (PNH) bij patienten die resistent zijn voor Eculizumab als gevolg van een C5 polymorfisme
    A.3.2Name or abbreviated title of the trial where available
    Coversin in PNH patients with resistance to Eculizumab
    Coversin bij PNH patienten die resistent zijn voor Eculizumab
    A.4.1Sponsor's protocol code numberVIP578
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02591862
    A.5.4Other Identifiers
    Name:Coversin VIP578Number:Coversin VIP578
    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 SponsorVolution Immuno Pharmaceuticals (UK) 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 supportVolution Immuno Pharmaceuticals (UK) Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVolution Immuno Pharmaceuticals (UK) Ltd
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street Address75-76 Wimpole Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1G 9RT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44(0)207025 7911
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCoversin
    D.3.2Product code rVA576
    D.3.4Pharmaceutical form Solution for injection/infusion
    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 INNNot applicable
    D.3.9.2Current sponsor coderVA576
    D.3.9.3Other descriptive namecoversin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.2
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    D. medicinal product typeCoversin is a recombinant tick saliva protein molecule which is a small protein complement C5 inhibitor.
    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
    Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH) in patients with resistance to Eculizumab due to complement C5 polymorphisms.
    Coversin bij Paroxysmale Nachtelijke Hemoglobinurie (PNH) bij patienten die resistent zijn voor Eculizumab als gevolg van een C5 polymorfisme.
    E.1.1.1Medical condition in easily understood language
    Paroxysmal Nocturnal Haemoglobinuria (PNH)
    Paroxysmale Nachtelijke Hemoglobinurie (PNH)
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10055629
    E.1.2Term Paroxysmal nocturnal hemoglobinuria
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective: Safety and tolerability of Coversin (rVA576)

    E.2.2Secondary objectives of the trial
    Efficacy of Coversin in the treatment of patients with PNH resistant to Eculizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with known paroxysmal nocturnal haemoglobinuria (PNH)
    LDH >= 1.5 ULN
    Resistance to eculizumab proven by both a recognised C5 polymorphism on genetic screening and complement inhibition on CH50 ELISA of < 100 % at concentrations of eculizumab in excess of 50 ug/ml
    Willing to self-inject Coversin daily of to receive daily subcutaneous injections by a home nurse or in a doctor's office or hospital clinic.
    Willing to receive appropriate prophylaxes against neisseria infection by either or both immunisation or continuous or intermittent antibiotics.
    Males or females taking adequate contraceptives precautions if of childbearing potential, 18 - 80 years of age
    Body weight >=50kg and <=100kg
    The patient has provided written informed consent
    Willing to avoid prohibited medications for duration of study
    Must be counselled regarding the possible reproductive risks of using Coversin and be advised to use an adequate method of contraception pending further data on reproductive toxicology
    E.4Principal exclusion criteria
    Body weight <50kg or >100kg
    Pregnancy (females)
    Use of tizanidine (if on ciprofloxacin)
    Use of eculizumab should be discontinued before coversin therapy is commenced. Ideally this should be 2 of more weeks before.
    Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom)
    Failure to satisfy the PI off fitness to participate for any other reason.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction in serum LDH (AUC) from Day 0 to Day 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    Measurement of change in LDH (AUC) from Day 0 (pre-dose) to Day 28 (AUC) compared with 28 days pre-treatment
    E.5.2Secondary end point(s)
    Measurement of Haemoglobin (Hb), haptoglobin (Hp), Change in LDH, Fatigue level using FACIT instrument, Quality of Life (EORTC QL-C30), PNH RBC clone size, Transfusion requirement, Adverse Events
    E.5.2.1Timepoint(s) of evaluation of this end point
    Measurement of Haemoglobin (Hb) at Day 28 & Day 180
    Measurement Haptoglobin (Hp) Day 28 & Day 180
    Measurement of Change in LDH from Day 0 (pre-dose) and at monthly intervals up to 1 year (Day 0 (pre-dose), 24 hrs (pre-dose), 48 hrs (pre-dose), Day 2, Day 5, Day 7, 14 and 21, Day 28, 35, 42, 49, Day 60 (weeks 8, 10 and 12), Day 90 (weeks 14, 16, 18, 20 and month 5), Day 180 (months 6, 7, 8, 9, 10 and 11), 1 year (month 12, and every 3 months), End of Study
    Measurement of Change in proportion of PNH from Day 0 - Day 90
    Change in Functional Assessment of Chronic Illness Therapy (FACIT) Score from Day 0 - Day 180
    Change in Quality of Life Questionnaire (EORTC QL-C30) Score from Day 0 to Day 180
    Number and types of adverse events (AE's)
    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 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. 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.8.3 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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 1
    F.1.3Elderly (>=65 years) No
    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 state6
    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 will undergo an initial period of 6 months treatment according to this protocol. At the expiry of this period, and on the recommendation of the PI, patients will have the option of remaining on long-term Coversin therapy and will enter a long term follow-up study.
    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 Decision2015-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
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