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    Summary
    EudraCT Number:2014-001672-55
    Sponsor's Protocol Code Number:MW2010-03-02
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-02
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2014-001672-55
    A.3Full title of the trial
    A multicenter, multinational, randomized, controlled, blinded study, performed in subjects with thermal burns, to evaluate the efficacy and safety of NexoBrid as compared to Standard of Care treatment
    Un studiu multicentric, multinaţional, randomizat, controlat, orb, efectuat pe subiecţi cu arsuri termice, pentru a evalua eficacitatea şi siguranţa NexoBrid comparativ cu tratamentul standard de îngrijire

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter, multinational, randomized, controlled, blinded study, performed in subjects with thermal burns, to evaluate the efficacy and safety of NexoBrid as compared to Standard of Care treatment
    Un studiu multicentric, multinaţional, randomizat, controlat, orb, efectuat pe subiecţi cu arsuri termice, pentru a evalua eficacitatea şi siguranţa NexoBrid comparativ cu tratamentul standard de îngrijire

    A.4.1Sponsor's protocol code numberMW2010-03-02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02148705
    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 SponsorMediWound Ltd.
    B.1.3.4CountryIsrael
    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 supportMediWound Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGCP-Service International Ltd. & Co.KG
    B.5.2Functional name of contact pointShanti Liebrecht
    B.5.3 Address:
    B.5.3.1Street AddressAnne-Conway-Str. 2
    B.5.3.2Town/ cityBremen
    B.5.3.3Post code28359
    B.5.3.4CountryGermany
    B.5.4Telephone number004942189 67 66 36
    B.5.5Fax number004942143 48 659
    B.5.6E-mailsliebrecht@gcp-service.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 NexoBrid
    D.2.1.1.2Name of the Marketing Authorisation holderMediWound Germany GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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/3/02/107
    D.3 Description of the IMP
    D.3.1Product nameNexoBrid
    D.3.4Pharmaceutical form Powder and gel for gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    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 Yes
    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.3.11.13.1Other medicinal product typemixture of enzymes (Bromelain) extracted from pineapple
    D.IMP: 2
    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 Collagenase Santyl Ointment
    D.2.1.1.2Name of the Marketing Authorisation holderHealthpoint Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameCollagenase Santyl Ointment
    D.3.4Pharmaceutical form Ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    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 Yes
    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.3.11.13.1Other medicinal product typeCollagenase enzyme derived from fermentation of Clostridium Histolyticum.
    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 placeboGel
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The study objective is to evaluate the efficacy and safety of NexoBrid in removing burn eschar earlier and reducing surgical needs in hospitalized subjects with thermal burns of 4-15% of Total Body Surface Area (TBSA).
    Obiectivul studiului este evaluarea eficacității și siguranței produsului NexoBrid în eliminarea mai rapidă a escarelor de la arsuri și în reducerea nevoilor chirurgicale la pacienții spitalizați cu arsuri termice pe 4-15% din suprafața corporală totală (TBSA).
    E.1.1.1Medical condition in easily understood language
    Dead tissue of a burn wound has to be removed to promote healing of the wound.
    Tesutul mort al ranilor prin arsura trebuie indepartat pentru a ajuta vindecarea ranilor
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level HLT
    E.1.2Classification code 10043418
    E.1.2Term Thermal burns
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study objective is to evaluate the efficacy and safety of NexoBrid in removing burn eschar earlier and reducing surgical needs in hospitalized subjects with thermal burns of 4-15% of Total Body Surface Area (TBSA).
    Obiectivul studiului este evaluarea eficacității și siguranței produsului NexoBrid în eliminarea mai rapidă a escarelor de la arsuri și în reducerea nevoilor chirurgicale la pacienții spitalizați cu arsuri termice pe 4-15% din suprafața corporală totală (TBSA).
    E.2.2Secondary objectives of the trial
    Secondary objectives are to examine if the following is achieved:
    1.Earlier eschar removal- time until complete eschar removal has been achieved.
    2.Reduction in surgical need- Incidence of surgical excision performed for eschar removal.
    3.Residual %TBSA with eschar measured at the end of the topical agent soaking period.
    4.Incidence of wound closure
    5.Time to reach complete wound closure assessed in days, starting from Randomization date.
    6.Long term Quality of Life will be measured using EQ5D and Burn Specific Health Scale- Brief (BSHS-B) at 3, 6, 9, 12, 18 and 24 months following to the confirmatory wound closure visit.
    7.Long term functionality evaluation of the extremities (using the ‘Lower Extremity Functional Scale’ and 'QuickDASH' questionnaires and 'Range Of Motion' measurements) will be evaluated at 3, 6, 9, 12, 18 and 24 months following to the confirmatory wound closure visit.
    Obiectivele secundare sunt urmatoarele:
    1. Eliminarea mai rapidă a escarelor- durata de timp până ce a fost realizată eliminarea completă a escarelor.
    2. Reducerea nevoilor chirurgicale- Incidența exciziei chirurgicale efectuate pentru eliminarea escarelor.
    3. %TBSA rămas cu escare măsurat la sfârșitul perioadei de înmuiere cu agent topic.
    4. Incidența închiderii rănii
    5. Durata de timp până la închiderea completă a rănii evaluată în zile, pornind de la data de randomizare.
    6. Calitatea Vieții pe termen lung va fi măsurată folosindu-se EQ5D și Scara de sănătate specifică arsurilor-Rezumat (BSHS-B) la 3, 6, 9, 12, 18 și 24 de luni după controlul care confirmă închiderea rănii.
    7. Evaluarea funcționalității pe termen lung a extremităților (folosind ‘Scara funcțiilor extremităților inferioare’ și chestionarele 'QuickDASH' și măsurătorile 'Range Of Motion') va fi efectuată la 3, 6, 9, 12, 18 și 24 de luni după controlul care confirmă închiderea rănii.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females; ≥ 18 and ≤ 70 years of age,
    2. Thermal burns caused by fire/flame, scalds or contact,
    3. Patient total burns area should be between 4% to 15% TBSA (≥ 4% and ≤ 15% ; SPT, DPT and/or FT in depth),
    4. Informed consent can be obtained within 48 hours of the burn injury.
    5. Patients who are willing and able to sign a written consent form.
    Wound level:
    At least one wound (a continuous burn area which can be treated in one session; might include several anatomical areas) in a patient should meet all following criteria:
    1. Wound that is ≥ 1% TBSA (not including face, perineal or genital),
    2. Wound is composed of DPT and/or FT in depth. Superficial partial thickness areas may be included in the wound area only if cannot be separated from deeper areas (e.g. surrounded by or mixed with DPT areas) and might interfere with the treatment of the deeper areas,
    3. Wound that is intended for surgical eschar removal,
    4. Wound’s blisters can be unroofed, as judged by the investigator.
    1. Bărbați și femei; ≥ 18 și ≤ 70 ani,
    2. Arsuri termice cauzate de foc / flacără, opărire sau prin contact,
    3. Suprafața totală a arsurilor pacientului ar trebui să fie între 4% și 15% TBSA (≥ 4% și ≤ 15% ; arsuri parțiale superficiale (SPT), arsurile parțiale profunde (DPT) și/sau în toată grosimea dermului (FT) în funcție de profunzime),
    4. Consimțământul în deplină cunoștință de cauză poate fi obținut în termen de 48 de ore de la accident.
    5. Pacienții care doresc și sunt în măsură să semneze un formular de consimțământ scris.
    Cel puțin una dintre rănile (o suprafață arsă continuă care poate fi tratată într-o ședință; poate include mai multe zone anatomice) unui pacient trebuie să respecte toate criteriile următoare:
    1. Rană care este ≥ 1% TBSA (nu sunt incluse fața, zona perineală sau genitală),
    2. Rana este formată din arsuri parțiale profunde și arsuri în toată grosimea dermului. Arsurile parțiale superficiale pot fi incluse în suprafața rănii doar dacă nu pot fi separate de suprafețele mai profunde (ex. înconjurate de sau amestecate cu zonele DPT) și pot interfera cu tratamentul suprafețelor mai profunde,
    3. Rană care este destinată eliminării chirurgicale a escarei,
    4. Bășicile rănii pot fi deschise, după cum consideră cercetătorul.

    E.4Principal exclusion criteria
    1. Patients who are unable to follow study procedures and follow up period,
    2. Modified Baux index ≥ 80,
    3. Patients with burned, charred fingers, 3rd degree in depth, possibly devoid of circulation,
    4. Patients with > 15% TBSA burns,
    5. Patients with abraded wound/s that cannot be treated by an enzymatic debrider application (NexoBrid or Collagenase) will be excluded from the study,
    6. Patients with electrical or chemical burns,
    7. Patients with DPT and/or FT facial burn wounds from flame, flash, explosion >0.5% TBSA (scald and contact burns are allowed),
    8. Patients with circumferential DPT and/or FT burns defined as Extremities at Risk (EAR) ,
    9. The following pre-enrollment dressings: a. Flammacerium, b. Silver Nitrate (AgNO3),
    10. Patients with pre-enrolment wounds which are covered by eschar heavily saturated with iodine or by SSD pseudoeschar (e.g. pseudoeschar as a result of SSD treatment),
    11. Patients with pre-enrollment escharotomy,
    12. Patients with diagnosed infections as described in Section 11.2.3 of study protocol,
    13. Any signs or history that may indicate smoke inhalation (e.g. flame burn to the upper body, flames in enclosed space, smoke and fumes on the patient and in mouth and nostrils, deep flame burns >0.5 %TBSA to the face, cough, hoarseness, stridor or breathing difficulty including tachypnea possibly related to smoke inhalation, etc.),
    14. Pregnant women (positive pregnancy test) or nursing mothers,
    15. Poorly controlled diabetes mellitus (HbA1c>9%) in patients with known diabetes as captured in the medical history,
    16. Patients with BMI greater than 34.0 kg/m2,
    17. ASA greater than 2 (see Appendix 15 in study protocol)
    18. Cardio-pulmonary disease (MI within 6 months prior to injury, pulmonary hypertension, COPD or pre-existing oxygen-dependent pulmonary diseases, broncho-pneumonia, steroid dependent asthma or uncontrolled asthma),
    19. Pre-existing diseases which interfere with circulation (peripheral vascular disease, edema, lymphedema, surgery to regional lymph nodes, obesity, varicose veins),
    20. Any conditions that would preclude safe participation in the study or adding further risk to the basic acute burn trauma (such as immuno-compromising diseases, life threatening trauma, severe pre-existing coagulation disorder, cardiovascular disorder, pulmonary disorder, liver disorder including post alcoholic abuse impaired function or neoplastic disease),
    21. Chronic systemic steroid intake,
    22. History of allergy and/or known sensitivity to pineapples, papaya, Bromelain or papain,
    23. Current (within 12 months prior to screening) suicide attempt,
    24. Mentally incapacitated adults who are incapable of giving legal consent (e.g. dementia, psychiatric patients, etc),
    25. Enrollment in any investigational drug trial within 4 weeks prior to screening,
    26. Current (within 12 months prior to screening) alcohol (daily consumption > 3 units for males and >2 units for females) or drug abuse ,
    27. Prisoners and incarcerated.
    1. Pacienții care sunt incapabili să urmeze procedurile studiului și perioada de monitorizare,
    2. Index Baux modificat ≥ 80,
    3. Pacienții cu degetele arse, carbonizate, gradul 3 în profunzime, eventual fără circulație,
    4. Pacienții cu arsuri > 15% TBSA,
    5. Pacienții cu răni cu escoriații, care nu pot fi tratate prin aplicarea unui unguent de debridare enzimatică (NexoBrid sau Colagenază), vor fi excluși din studiu,
    6. Pacienții cu arsuri electrice sau chimice,
    7. Pacienții cu arsuri faciale DPT și/sau FT provenite de la flacără, scântei, explozie >0.5% TBSA (arsurile prin opărire sau contact sunt permise),
    8. Pacienții cu arsuri circumferențiale DPT și/sau FT definite ca Extremități în pericol (EAR) ,
    9. Următoarele pansamente pre-înrolare: a. Flammacerium, b. Nitrat de argint (AgNO3),
    10. Pacienții cu răni pre-înrolare care sunt acoperite de escare puternic saturat de iod sau cu pseudoescare SSD (de exemplu, pseudoescară ca urmare a tratamentului SSD),
    11. Pacienții cu escarotomie pre-înrolare,
    12. Pacienții cu infecții diagnosticate conform descrierii din Secțiunea 11.2.3 a protocolului studiului,
    13. Orice semne sau istoric care pot indica inhalare de fum (de exemplu, arsură de flacără la partea superioară a corpului, flăcări în spațiu închis, fum și vapori pe pacient și în gură și în nas, arsuri profunde de flacără 0,5% din TBSA pe față, tuse, răgușeală, stridor sau dificultăți de respirație, inclusiv tahipnee, legate probabil de inhalarea de fum etc.),
    14. Femeile gravide (test de sarcină pozitiv) sau mame care alaptează,
    15. Diabet zaharat slab controlat (HbA1c>9%) la pacienții la care diabetul este cunoscut în istoricul medical,
    16. Pacienții cu IMC mai mare de 34.0 kg/m2,
    17. ASA mai mare de 2 (a se vedea Anexa 15 din protocol studiului)
    18. Boli cardio-pulmonare (IM în mai puțin de 6 luni înainte de leziune, hipertensiune pulmonara, BPOC sau boli pulmonare dependente de oxigen pre-existente, bronho-pneumonie, astm dependent de steroizi sau astm necontrolat),
    19. Afecțiuni preexistente, care interferează cu circulația (boli vasculare periferice, edem, limfedem, intervenții chirurgicale la ganglionii limfatici regionali, obezitate, varice),
    20. Orice condiții care ar împiedica participarea în condiții de siguranță la studiul clinic sau ar adăuga alte riscuri la trauma acută generată de arsură (cum ar fi bolile compromițătoare pentru imunitate, traume care au pus viața în pericol, tulburări de coagulare preexistente severe, tulburări cardiovasculare, tulburări pulmonare, tulburări hepatice, inclusiv funcția hepatică alterată după abuz de alcool funcție sau boli neoplazice),
    21. Consumul cronic de steroizi sistemici,
    22. Antecedente de alergie și / sau sensibilitate cunoscută la ananas, papaya, bromelaină sau papaină,
    23. Tentativa de suicid recentă (cu maxim 12 luni înainte de triaj)
    24. Adulți cu incapacitate mintală care nu sunt capabili să își dea consimțământul legal (e.g. demență, pacienți de psihiatrie, etc),
    25. Înscrierea în orice studiu clinic al unui medicament experimental, cu maxim 4 săptămâni înainte de triaj,
    26. Abuz actual (cu maxim 12 săptămâni înainte de triaj) de alcool (consum zilnic > 3 unități pentru bărbați și >2 unități pentru femei) sau droguri ,
    27. Prizonieri și încarcerări.

    E.5 End points
    E.5.1Primary end point(s)
    The following primary endpoints will be evaluated in this study:
    1. Incidence of complete eschar removal: Demonstrate superiority over SOC treatment for eschar removal as measured by incidence of complete eschar removal by the end of the topical agent soaking period.
    2. Reduction in surgical needs: Demonstrate superiority over SOC treatment in reduction in surgical need for excisional eschar removal as measured by an analysis of % wound area surgically excised for eschar removal (tangential/ minor/ avulsion/ Versajet and/or dermabrasion excision).
    3. Cosmesis and Function: Demonstrate non-inferiority to SOC treatment in quality of scars of burns treated with NexoBrid, measured at 24 months from wound closure.
    Următoarele criterii principale vor fi evaluate în acest studiu:
    1. Incidența eliminării complete a escarelor: Demonstrarea superiorității față de tratamentul standard de îngrijire (TSI)) în eliminarea escarelor, măsurată prin incidența eliminării complete a escarelor la sfârșitul perioadei de înmuiere cu agent topic.
    2. Reducerea nevoilor chirurgicale: Demonstrarea superiorității față de tratamentul standard de îngrijire (TSI) în reducerea nevoii chirurgicale de eliminare a escarelor prin proceduri excizionale, măsurată prin analiza procentuală a suprafeței rănii excizate chirurgical pentru îndepartarea escarele (excizie tangențială / minoră / separare / Versajet şi/sau dermabraziune).
    3. Nivel cosmetic și funcțional: Demonstrarea lipsei de inferioritate față de tratamentul standard de îngrijire (TSI) în ceea ce privește calitatea cicatricilor de la arsuri tratate cu NexoBrid, măsurată la 24 de luni de la închiderea plăgii.

    E.5.1.1Timepoint(s) of evaluation of this end point
    1. End of the topical agent soaking period.
    2. Time of complete eschar removal.
    3. 24 months from wound closure.
    1. Sfârșitul perioadei de înmuiere cu agent topic.
    2. Timpul de eliminare completa a escarelor
    3. 24 de luni de la închiderea plăgii

    E.5.2Secondary end point(s)
    1.Earlier eschar removal- time until complete eschar removal has been achieved. This will be assessed at the end of eschar removal starting from randomization date (days).
    2.Reduction in surgical need- Incidence of surgical excision performed for eschar removal. This EP supplements the primary EP by further assessing NexoBrid’s impact on the reduction in surgical needs.
    3.Residual %TBSA with eschar measured at the end of the topical agent soaking period.
    4.Incidence of wound closure
    5.Time to reach complete wound closure assessed in days, starting from Randomization date.
    6.Long term Quality of Life will be measured using EQ5D and Burn Specific Health Scale- Brief (BSHS-B) at 3, 6, 9, 12, 18 and 24 months following to the confirmatory wound closure visit.
    7.Long term functionality evaluation of the extremities (using the ‘Lower Extremity Functional Scale’ and 'QuickDASH' questionnaires and 'Range Of Motion' measurements) will be evaluated at 3, 6, 9, 12, 18 and 24 months following to the confirmatory wound closure visit.
    1. Eliminarea mai rapidă a escarelor- durata de timp până ce a fost realizată eliminarea completă a escarelor.
    2. Reducerea nevoilor chirurgicale- Incidența exciziei chirurgicale efectuate pentru eliminarea escarelor.
    3. %TBSA rămas cu escare măsurat la sfârșitul perioadei de înmuiere cu agent topic.
    4. Incidența închiderii rănii
    5. Durata de timp până la închiderea completă a rănii evaluată în zile, pornind de la data de randomizare.
    6. Calitatea Vieții pe termen lung va fi măsurată folosindu-se EQ5D și Scara de sănătate specifică arsurilor-Rezumat (BSHS-B) la 3, 6, 9, 12, 18 și 24 de luni după controlul care confirmă închiderea rănii.
    7. Evaluarea funcționalității pe termen lung a extremităților (folosind ‘Scara funcțiilor extremităților inferioare’ și chestionarele 'QuickDASH' și măsurătorile 'Range Of Motion') va fi efectuată la 3, 6, 9, 12, 18 și 24 de luni după controlul care confirmă închiderea rănii.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -time until complete eschar removal has been achieved.
    -end of the topical agent soaking period.
    -Time to reach complete wound closure assessed in days, starting from Randomization date.
    -3, 6, 9, 12, 18 and 24 months following to the confirmatory wound closure visit.
    - durata de timp până ce a fost realizată eliminarea completă a escarelor
    - sfârșitul perioadei de înmuiere cu agent topic
    - durata de timp până la închiderea completă a rănii evaluată în zile, pornind de la data de randomizare
    -3, 6, 9, 12, 18 și 24 de luni după controlul care confirmă închiderea rănii
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Imunogenicitate
    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 Yes
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Collagenase Santyl
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Canada
    Israel
    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
    Ultima vizita a ultimului subiect
    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: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-07-02. Yes
    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 Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 175
    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 are treated according to standard of care after end of participation in the trial.
    Dupa ce participarea in studiul clinic se incheie, pacientii vor fi tratati conform standardului de ingrijire.
    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 Decision2014-10-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-08-20
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