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    Summary
    EudraCT Number:2011-001455-37
    Sponsor's Protocol Code Number:1331TMF
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-06-01
    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 ConcernedNorway - NOMA
    A.2EudraCT number2011-001455-37
    A.3Full title of the trial
    Prospective randomized interventional study. Compare the effect of bleomycin and Tetradecyl Sodium Sulphate (Fibrovein) in the treatment of venous malformations. Clinical neurological and neurophysiological study of a subpopulation of patients with venous malformations.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective randomized interventional study in patients with venous malformations.
    A.4.1Sponsor's protocol code number1331TMF
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01347294
    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 SponsorDepartment of Radiology, Oslo University Hospital, Norway
    B.1.3.4CountryNorway
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportOslo Universitetessykehus, Rikshospitalet
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOslo Universitetssykehus, Rikshospitalet
    B.5.2Functional name of contact pointTone Meyer Fjeld
    B.5.3 Address:
    B.5.3.1Street AddressSognsvannsveien 20
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0027
    B.5.3.4CountryNorway
    B.5.4Telephone number+4723070000
    B.5.5Fax number+4723072610
    B.5.6E-mailtone.meyer@gmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Bleomycin Baxter
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameBleomycin
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    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 Yes
    D.2.1.1.1Trade name Fibrovein 3% The product licence holder is: STD pharmaceutical products limited, Hereford, HR4 OEL, UK The manufacture is CD pharmaceuticals, Wrexham LL13 9 UF, UK
    D.2.1.1.2Name of the Marketing Authorisation holderUK
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFibrovein 3%
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Venous malformation
    E.1.1.1Medical condition in easily understood language
    vascular abnormality of the venous system
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10047229
    E.1.2Term Venous malformation NOS
    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
    Compare the efficacy and side effects of bleomycin and sodium tetradecyl sulfate (Fibrovein ™) in the treatment of venous malformations. Group differences in reported pain after treatment will be the main effect variable.
    E.2.2Secondary objectives of the trial
    Secondary outcome measures are relaps rate, physical function, emotional function, subjective assessment of improvement and additional symptoms or side effects.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Measure the proportion of patients with a risk of nerve involvement caused by a nearby venous malformation by having the patient undergo a thorough diagnostic imaging (ultrasound and magnetic resonance), clinical neurological examination, thermal testing, and EMG nevrografi in advance of any treatment. Group Differences in the incidence of neuropathic pain is the main variable.

    2. Quality of life survey of patients with venous and arteriovenous malformations using SF-36 questionnaire. The purpose of this study will be:
    A. Examining health-related quality of life in patients with vascular malformations before treatment of the condition.
    B. Examining health-related quality of life in patients with vascular malformations 1 year after stopping treatment or completed the diagnosis, unless the treatment is implemented.

    3. MRI(magnetic resonance imaging) examination of patients with venous and arteriovenous malformations using 2 additional sequences named TWIST (time-resolved angiography with interleaved stochastic trajectories) and VIBE (volume-interpolated breath-hold examination). The purpose of this study will be:
    A. Examining the usefulness of MRI sequences TWIST and VIBE in the study of venous and arteriovenous malformations.
    B. Compare TWIST MRA with conventional angiography (gold standard), for the representation of distribution and description of flow dynamics in arteriovenous malformations.
    C. Examine whether haemodynamics in vascular malformations presented with TWIST and VIBE MRI can predict the treatment effect and clinical outcome.
    E.3Principal inclusion criteria
    All patients of both sexes over 12 years referred to hospital with suspected venous malformation will be requested study participation. Written consent must be provided. Patients between 12 and 16 must have parental consent.
    E.4Principal exclusion criteria
    Contraindications to the use of bleomycin:
     Renal impairment
     compromised lung function
     Previously demonstrated hypersensitivity to bleomycin.
     Known previous malignant disease

    Contraindications to the use of fibrovein:
     Allergy to sodium tetradecyl sulfate
     Significant obesity
     Heart Failure / Pulmonary Edema
    o Previously, severe reaction to X-ray contrast agent
    o severe allergies and / or severe bronchial asthma
    o Local or systemic infection
    o Severe illness that complicates monitoring
    o Pregnant / planning pregnancy or breast-feeding
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is reduction in pain scores one year after treatment with at least 30% difference between the most compared with the least efficacous treatment.
    VAS (Visual Analogue Scale)shall be used and the standard deviation is estimated to be 2.8 .
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary end point is status after one year.
    E.5.2Secondary end point(s)
    Changes in pain intensity as a function of time and treatment allocation at every time point.
    E.5.2.1Timepoint(s) of evaluation of this end point
    By using various questionnaires that pasients have to fill out, the pain will be measured before starting treatment and then 6 weeks and 12 months after ended treatment.
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.3.1Comparator description
    bleomycin
    E.8.2.4Number of treatment arms in the trial3
    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 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 months7
    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 Yes
    F.1.1Number of subjects for this age range: 10
    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: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state130
    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 have the opportunity to further sclerotherapy at the hospital if symptoms were relapsed. This will be unchanged from current practice.
    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 Decision2011-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-21
    P. End of Trial
    P.End of Trial StatusOngoing
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