Klinikai vizsgálatok Nct

Summary
EudraCT Number:2006-003821-10
Sponsor's Protocol Code Number:ML20681
National Competent Authority:Spain - AEMPS
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2012-03-20
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 ConcernedSpain - AEMPS
A.2EudraCT number2006-003821-10
A.3Full title of the trial
Estudio aleatorizado, abierto y cruzado para evaluar la tolerabilidad del dispositivo de inyección sin aguja B2000 para la administración de enfuvirtida.
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Estudio para evaluar la tolerabilidad del dispositivo de inyección sin aguja para la administración de Fuzeon.
A.3.2Name or abbreviated title of the trial where available
Tolerabilidad de la administración de Fuzeon®
A.4.1Sponsor's protocol code numberML20681
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 SponsorRoche Farma, S.A.
B.1.3.4CountrySpain
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 supportRoche Farma S.A.
B.4.2CountrySpain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationRoche Farma S.A.
B.5.2Functional name of contact pointMar López
B.5.3 Address:
B.5.3.1Street AddressC/ Eucalipto 33
B.5.3.2Town/ cityMadrid
B.5.3.3Post code28016
B.5.3.4CountrySpain
B.5.4Telephone number91 324 81 00
B.5.5Fax numberN/A
B.5.6E-mailnotapplicable@notapplicable.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 Fuzeon
D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd
D.2.1.2Country which granted the Marketing AuthorisationSpain
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.3.4Pharmaceutical form Powder and solvent 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 INNEnfuvirtide
D.3.9.1CAS number 159519-65-0
D.3.9.2Current sponsor codeRo 29-9800
D.3.9.3Other descriptive nameENF, T-20
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number90
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 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 Fuzeon
D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd
D.2.1.2Country which granted the Marketing AuthorisationSpain
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.3.4Pharmaceutical form Powder and solvent 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 INNEnfuvirtide
D.3.9.1CAS number 159519-65-0
D.3.9.2Current sponsor codeRo 29-9800
D.3.9.3Other descriptive nameENF, T-20
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number90
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
Infección por el VIH, no especificada
E.1.1.1Medical condition in easily understood language
Infección por el VIH
E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 14.1
E.1.2Level LLT
E.1.2Classification code 10020441
E.1.2Term Human immunodeficiency virus infection, unspecified
E.1.2System Organ Class 10021881 - Infections and infestations
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
Evaluar el DISA B2000 para determinar la tolerabilidad basada en los signos y síntomas que se asocian a la inyección de ENF, cuando se utiliza el DISA B2000 en comparación con una aguja/jeringuilla (JA) 27 G ½? estándar, suministrada en la actualidad con las presentaciones comerciales de ENF, durante la autoadministración prolongada.
E.2.2Secondary objectives of the trial
Determinar la adherencia, la satisfacción global, y las preferencias para la autoadministración prolongada de ENF entre el dispositivo B2000 y una jeringuilla y aguja de 27G ½?.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
Para ser seleccionado para participar en este estudio, los pacientes deben cumplir todos los criterios de inclusión que se enumeran a continuación durante la selección y antes del comienzo del tratamiento:
1.Paciente VIH-1 positivo en el que esté indicado, según la aprobación en ficha técnica, el inicio del tratamiento con enfuvirtida
2.Paciente con edad igual o superior a 18 años en el momento de la selección.
3.Si la paciente puede ser gestante, presenta durante la selección un resultado negativo documentado en una prueba de embarazo, y dispone de un resultado negativo de una prueba de orina en las 24 horas anteriores a la primera dosis de la medicación del estudio.
4.Paciente que acepta utilizar una forma fiable de anticoncepción durante todo el estudio.
5.Paciente con la voluntad y la capacidad de utilizar ENF en combinación con otros tratamientos ARV.
6.Paciente con la voluntad y la capacidad de dar su consentimiento informado por escrito.
E.4Principal exclusion criteria
Los pacientes con cualquiera de los siguientes historiales y/o patologías durante la selección, o antes del comienzo del tratamiento, no serán adecuados para participar en este estudio:
1.Mujer embarazada, o lactante, o que prevea quedar embarazada durante el estudio.
2.Paciente con cualquier acontecimiento adverso activo (incluidas las anomalías de laboratorio), que bajo el criterio del investigador se considere inadecuado desde el punto de vista clínico.
3.Paciente con evidencia de abuso de alcohol y/o drogas dentro del año anterior a la invitación a participar en el estudio, que a juicio del investigador pueda hacerle incapaz de cumplir las condiciones del protocolo.
4.Paciente previamente tratado con ENF o de T-1249.
5.Paciente que haya sido tratado con las medicaciones prohibidas o que haya sido sometido a las intervenciones prohibidas, enumeradas en el apartado 6.4 del protocolo, en los 14 días anteriores al basal (día 1).
6.Paciente con mala adherencia a regímenes de tratamiento ARV anteriores que, a juicio del investigador, puedan sugerir que será incapaz de cumplir las condiciones del protocolo.
7.Paciente incapaz de autoinyectarse ENF tal y como se indica en el protocolo.
8.Paciente con alguna enfermedad grave en la actualidad o cualquier otra patología que pueda hacerle, en opinión del investigador, inadecuado para el estudio.
9.Paciente con evidencia de infecciones oportunistas activas no tratadas (incluyendo cualquier anomalía en un examen oftalmoscópico, a menos que un oftalmólogo la considere benigna), o una fiebre sin explicación superior o igual a 38,5ºC durante siete días consecutivos, dentro de los 30 días anteriores a la primera visita de selección. A los pacientes sometidos a un tratamiento antiinfeccioso estable o un régimen profiláctico se les permite participar en el estudio.
10.Paciente VIH+ que no haya recibido nunca fármacos ARVs para tratar su enfermedad.
11.Pacientes que estén recibiendo fármacos en investigación, que no sean los disponibles en programas de acceso expandido.
E.5 End points
E.5.1Primary end point(s)
Score resultado de la suma de la máxima graduación de intensidad de los 8 signos y síntomas de toxicidad de las reacciones locales a la administración de enfuvirtida (como se utilizó en los estudios en fase III de ENF): dolor/molestia (grado 1-4), eritema (grado 1-4), induración (grado 1-4), prurito (grado 1-3), nódulos y quistes (grado 1-4), equimosis (grado 1-4), duración de la lesión (grado 1-4) y número de lesiones individuales presentes (grado 1-4)
E.5.1.1Timepoint(s) of evaluation of this end point
8 semanas
E.5.2Secondary end point(s)
Determinar la adherencia, la satisfacción global, y las preferencias para la autoadministración prolongada de ENF entre el dispositivo B2000 y una jeringuilla y
aguja de 27G ½?.
E.5.2.1Timepoint(s) of evaluation of this end point
8 semanas
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 No
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 Yes
E.6.13.1Other scope of the trial description
Investigación de resultados de salud
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 Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over Yes
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.8.2.4Number of treatment arms in the trial2
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 concerned19
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 Information not present in EudraCT
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
Última visita del último paciente.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years0
E.8.9.1In the Member State concerned months6
E.8.9.1In the Member State concerned days7
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 0
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 0
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 state41
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)
Si el paciente decide continuar administrándose enfuvirtide con el dispositivo B2000, se le suministrará y continuará en seguimiento por posibles efectos secundarios debidos al dispositivo hasta la autorización del mismo en España
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 Decision2006-11-27
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2006-11-10
P. End of Trial
P.End of Trial StatusOngoing

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