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Summary
EudraCT Number:2021-005493-25
Sponsor's Protocol Code Number:EFISS
National Competent Authority:Czechia - SUKL
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2022-02-08
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
A. Protocol Information
A.1Member State ConcernedCzechia - SUKL
A.2EudraCT number2021-005493-25
A.3Full title of the trial
Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery: A randomized pilot study (EFISS trial)
Vliv profylaktického podání fibrinogenu u operací skoliózy: Randomizovaná pilotní studie (EFISS)
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Effect of prophylactic fibrinogen concentrate in surgery of abnormal lateral curvature of the spine: A randomized pilot study (EFISS trial)
Vliv profylaktického podání fibrinogenu u operací abnormálně vychýlené páteře do strany: Randomizovaná pilotní studie (EFISS studie)
A.4.1Sponsor's protocol code numberEFISS
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 SponsorFakultní nemocnice Brno
B.1.3.4CountryCzechia
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 supportFakultní nemocnice Brno
B.4.2CountryCzechia
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationMasarykova univerzita
B.5.2Functional name of contact pointMichaela Kubelová
B.5.3 Address:
B.5.3.1Street AddressKamenice 5
B.5.3.2Town/ cityBrno
B.5.3.3Post code625 00
B.5.3.4CountryCzechia
B.5.4Telephone number00420549493842
B.5.6E-mailmichaela.kubelova@med.muni.cz
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 HAEMOCOMPLETTAN P 20 MG/ML INJ/INF PLV SOL
D.2.1.1.2Name of the Marketing Authorisation holderCSL Behring GmbH Emil-von-Behring-Str. 76 35041 Marburg, Germany
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 No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameHAEMOCOMPLETTAN P
D.3.4Pharmaceutical form Powder for solution for injection/infusion
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 INNFibrinogenum humanum
D.3.9.1CAS number 9001-32-5
D.3.9.3Other descriptive nameHUMAN FIBRINOGEN
D.3.9.4EV Substance CodeSUB12502MIG
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number20
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 Yes
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
Scoliosis
Skolióza
E.1.1.1Medical condition in easily understood language
An abnormal lateral curvature of the spine
Abnormálně vychýlená páteř do strany
E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level PT
E.1.2Classification code 10039727
E.1.2Term Scoliosis surgery
E.1.2System Organ Class 10042613 - Surgical and medical procedures
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
The primary objective of a clinical trial is to assess the safety of perioperative infusion of Haemocomplettan P in scoliosis surgery in the paediatric population.
Primárním cílem klinické studie je posoudit bezpečnost perioperačně podané infuze Haemocomplettanu P při operaci skoliózy u dětské populace.
E.2.2Secondary objectives of the trial
The secondary objective is to investigate the additional safety information, efficacy and feasibility of a prophylactic administration of fibrinogen in paediatric spinal surgery.
Sekundárním cílem je prozkoumat další informace o bezpečnosti, účinnosti a proveditelnosti profylaktického podávání fibrinogenu v dětské spinální chirurgii.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
1. Age < 18 years of age at the time of enrolment
2. Elective scoliosis surgery
3. Signed the relevant informed consent form
4. Sexually active participants (≥ 15 years old) must agree to the use of following methods of contraception for the duration of this clinical trial:
a) Women - proper use of a highly reliable method of contraception, i.e. combined hormonal contraception (oral, vaginal or transdermal form), gestagen hormonal contraceptives associated with ovulation inhibition (oral or injectable form) or sexual abstinence.
b) Men - sexual abstinence or the use of an adequate contraceptive method (i.e. condom) in case of sexual intercourse.
1. Věk < 18 let v době zahájení
2. Elektivní operace skoliózy
3. Podepsal příslušný formulář informovaného souhlasu
4. Sexuálně aktivní účastníci (≥ 15 let) musí souhlasit s používáním následujících metod antikoncepce po dobu trvání této klinické studie:
a) Ženy - správné používání vysoce spolehlivé metody antikoncepce, tj. kombinované hormonální antikoncepce (orální, vaginální nebo transdermální forma), gestagenní hormonální antikoncepce spojené s inhibicí ovulace (perorální nebo injekční forma) nebo sexuální abstinence.
b) Muži - sexuální abstinence nebo použití vhodné antikoncepční metody (tj. kondomu) v případě pohlavního styku.
E.4Principal exclusion criteria
1. Diagnosed congenital or acquired coagulopathy
2. Use of anticoagulants with the exception of perioperative prophylactic administration of LMWH to prevent VTE
3. Known hypersensitivity to the active substance or to any of the excipients of IMP
4. History of deep vein thrombosis or pulmonary embolism
5. Pregnancy and lactation.
1. Diagnostikovaná vrozená nebo získaná koagulopatie
2. Použití antikoagulancií s výjimkou profylaktického perioperačního podání LMWH k prevenci TEN
3. Známá přecitlivělost na léčivou látku nebo na kteroukoli pomocnou látku IMP
4. Hluboká žilní trombóza nebo plicní embolie v anamnéze
5. Těhotenství a kojení.
E.5 End points
E.5.1Primary end point(s)
The primary objective of a clinical trial is to assess the safety of perioperative infusion of Haemocomplettan P in scoliosis surgery in the paediatric population. The following primary endpoint will be monitored to evaluate the primary objective:
1.) Incidence of any adverse events and reactions during participation in the study
Primárním cílem klinické studie je posoudit bezpečnost peroperační infuze Haemocomplettanu P při operaci skoliózy u dětské populace. K vyhodnocení primárního cíle bude sledován následující primární endpoint:
1.) Výskyt jakýchkoli nežádoucích příhod a reakcí během účasti ve studii

E.5.1.1Timepoint(s) of evaluation of this end point
will be evaluated at the end of the study
zhodnoceno bude na konci studie
E.5.2Secondary end point(s)
The secondary objective is to investigate the additional safety information, efficacy and feasibility of a prophylactic administration of fibrinogen in paediatric spinal surgery.
Secondary endpoints are as follows:
1.) Incidence of adverse events and reactions according to following Adverse Events of Special Interest (AESI)
2.) Additional safety information
3.) Comparison of demographic characteristics between study groups
4.) Comparison of laboratory values of selected haematological parameters between study groups
5.) Comparison of blood loss level and its compensation between study groups
6.) Feasibility assessment
Sekundárním cílem je prozkoumat další informace o bezpečnosti, účinnosti a proveditelnosti profylaktického podávání fibrinogenu v dětské spinální chirurgii.
Budou monitorovány nasledujúcí body za účelem vyhodnocení sekundárního cíle:
1.) Výskyt nežádoucích příhod a reakcí podle následujících nežádoucích příhod zvláštního zájmu (AESI)
2.) Další bezpečnostní informace
3.) Porovnání demografických charakteristik mezi studijními skupinami
4.) Porovnání laboratorních hodnot vybraných hematologických parametrů mezi studijními skupinami
5.) Porovnání úrovně krevní ztráty a její kompenzace mezi studijními skupinami
6.) Posouzení proveditelnosti
E.5.2.1Timepoint(s) of evaluation of this end point
Day 28
Den 28
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis Yes
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) 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) No
E.8.2.2Placebo No
E.8.2.3Other Yes
E.8.2.3.1Comparator description
control group, where a standard of care will be used (without IMP)
E.8.2.4Number of treatment arms in the trial2
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
poslední návštěva posledního pacienta
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 months8
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: 32
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) Yes
F.1.1.5.1Number of subjects for this age range: 2
F.1.1.6Adolescents (12-17 years) Yes
F.1.1.6.1Number of subjects for this age range: 30
F.1.2Adults (18-64 years) No
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 Yes
F.3.3.6.1Details of subjects incapable of giving consent
Subjects under 18.
Subjekty do 18 let.
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state32
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)
None.
Žádná.
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 Decision2022-03-11
N.Ethics Committee Opinion of the trial application
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2023-07-11

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