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Ensayo clínico de fase II, doble ciego, aleatorizado, de múltiples dosis, cruzado, de tres tratamientos, tres períodos y seis secuencias, controlado con placebo, para evaluar la eficacia, farmacocinética, farmacodinámica, la seguridad y la tolerabilidad de bromuro de glicopirronio en niños con asma de 6 a menos de 12 años de edad

  • Protocol code: CQVM149C2201
  • EudraCT code: 2021-004972-32
  • Pathology: Asthma
  • Pharmac:  Glycopyrronium (bromide)
  • Promoter: Novartis
  • Principal investigator:  Garriga Baraut, Maria Teresa
  • Research group:  Creixement i desenvolupament
  • Service: Al·lergologia i Pneumologia pediàtrica
  • Phase: Fase II
  • Recruiting: Open
  • Status: Activo

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Controller: Fundació Hospital Universitari Vall Hebron Institut de Recerca – VHIR- G60594009.
Purpose: Request for information on VHIR clinical research.
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Data retention time: As long as they are useful for the purpose for which they were collected and responsibilities may arise.
Rights: You can access, rectify, delete your data, oppose or limit its processing and request its portability, as well as revoke your consent without retroactive effects by contacting lopd@vhir.org. The revocation of consent and the opposition to the processing of your data will prevent the purpose from being carried out. DPO: dpd@ticsalutsocial.org. More information 
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Ensayo en fase III, doble ciego, aleatorizado y controlado con placebo del tratamiento adyuvante con ganaxolona (GNX) en niños y adultos con epilepsia relacionada con el complejo de esclerosis tuberosa (CET) (TrustTSC)

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Controller: Fundació Hospital Universitari Vall Hebron Institut de Recerca – VHIR- G60594009.
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Data retention time: As long as they are useful for the purpose for which they were collected and responsibilities may arise.
Rights: You can access, rectify, delete your data, oppose or limit its processing and request its portability, as well as revoke your consent without retroactive effects by contacting lopd@vhir.org. The revocation of consent and the opposition to the processing of your data will prevent the purpose from being carried out. DPO: dpd@ticsalutsocial.org. More information 
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Estudio con enmascaramiento doble, controlado con placebo, de aumento progresivo de la dosis ara evaluar la eficacia, la seguridad y la farmacocinética de la voclosporina en adolescentes con nefritis lúpica

  • Protocol code: AUR-VCS-2020-03
  • EudraCT code: 2020-005807-37
  • Pathology: Nefritis lúpica
  • Pharmac: Voclosporin
  • Promoter: Aurinia Pharmaceuticals Inc
  • Principal investigator:  Ariceta Iraola, Gema
  • Research group:  Fisiopatologia renal
  • Service: Nefrologia Pediàtrica
  • Phase: Phase III
  • Recruiting: Closed
  • Status: Cerrado

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Controller: Fundació Hospital Universitari Vall Hebron Institut de Recerca – VHIR- G60594009.
Purpose: Request for information on VHIR clinical research.
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Rights: You can access, rectify, delete your data, oppose or limit its processing and request its portability, as well as revoke your consent without retroactive effects by contacting lopd@vhir.org. The revocation of consent and the opposition to the processing of your data will prevent the purpose from being carried out. DPO: dpd@ticsalutsocial.org. More information 
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Estudio aleatorizado, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de crinecerfont (NBI-74788) en sujetos pediátricos con hiperplasia suprarrenal congénita clásica, seguido de un tratamiento abierto

  • Protocol code: NBI-74788-CAH2006
  • EudraCT code: 2020-004381-19
  • Pathology: Classic Congenital Adrenal Hyperplasia (CAH)
  • Pharmac: Crinecerfont (NBI-74788)
  • Promoter: Neurocrine Biosciences
  • Principal investigator:  Clemente Leon, Maria
  • Research group:  Growth and Development
  • Service: Endocrinologia pediàtrica
  • Phase: Phase III
  • Recruiting: Closed
  • Status: Finalizado

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Estudio de cohortes de fase 2, con un solo grupo, abierto para evaluar la seguridad, la eficacia y lafarmacocinética del tratamiento con esparsentán en pacientes pediátricos con determinadasenfermedades glomerulares proteinúricas (EPPIK).

  • Protocol code: RTRX-RE021-201
  • EudraCT code: 2021-000621-27
  • Pathology: Proteinuric glomerular diseases including: Focal segmental glomerulosclerosis (FSGS) Minimal change disease (MCD) Immunoglobulin A nephropathy (IgAN) Immunoglobulin A vasculitis (IgAV) Alport syndrome (AS)
  • Pharmac: Sparsentan
  • Promoter: Travere Therapeutics
  • Principal investigator:  Ariceta Iraola, Gema
  • Research group:  Kidney Physiopathology
  • Service: Pediatric Nephrology
  • Phase: Phase II
  • Recruiting: Closed
  • Status: Finalizado

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Estudio en fase III, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de mitapivat en sujetos pediátricos con deficiencia de piruvato cinasa que reciben transfusiones con regularidad, seguido de un periodo de extensión abierto de 5 años

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Data retention time: As long as they are useful for the purpose for which they were collected and responsibilities may arise.
Rights: You can access, rectify, delete your data, oppose or limit its processing and request its portability, as well as revoke your consent without retroactive effects by contacting lopd@vhir.org. The revocation of consent and the opposition to the processing of your data will prevent the purpose from being carried out. DPO: dpd@ticsalutsocial.org. More information 
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Estudio de fase I/II, de escalada de dosis y expansión de dosis, de ZN-c3 en combinación con gemcitabina en adultos y niños con osteosarcoma recidivo o refractario al tratamiento.

  • Protocol code: ZN-c3-003
  • EudraCT code: 2021-000021-27
  • Pathology: Osteosarcoma recidivado o resistente al tratamiento
  • Pharmac: Gemcitabine
  • Promoter: K-Group Beta
  • Principal investigator:  Gros Subias, Luís
  • Research group:  Childhood Cancer and Blood Disorders
  • Service: Pediatric Oncohematology
  • Phase: Fase I
  • Recruiting: Closed
  • Status: Cerrado

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Ensayo clínico de fase I/II de terapia de genes de células madre hematopoyéticas autólogas para inmunodeficiencia combinada grave con deficiencia de RAG1.

  • Protocol code: RAG1-2019-01
  • EudraCT code: 2019-002343-14
  • Pathology: Patients with severe combined immunodeficiency (SCID) based on a genetic defect in the Recombinase Activating Gene 1 (RAG1)
  • Pharmac: AUTOLOGOUS HEMATOPOIETIC STEM CELL GENE THERAPY
  • Promoter: Leiden University Medical Center (LUMC)
  • Principal investigator:  Soler Palacín, Pere
  • Research group:  Infecció i immunitat al pacient pediàtric
  • Service: Patologia Infecciosa e Inmunologia pediàtrica
  • Phase: Phase II
  • Recruiting: Open
  • Status: Activo

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Controller: Fundació Hospital Universitari Vall Hebron Institut de Recerca – VHIR- G60594009.
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Estudio de extensión, abierto, multicéntrico y en pacientes ambulatorios, para evaluar la seguridad y la tolerabilidad de Staccato® Alprazolam en participantes en el estudio de 12 o más años de edad con estereotipias prolongadas

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Estudio para investigar la eficacia y la seguridad de Staccato® alprazolam enparticipantes en el estudio >=12 años de edad con epilepsia

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Controller: Fundació Hospital Universitari Vall Hebron Institut de Recerca – VHIR- G60594009.
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Ensayo Clínico de transferencia génica fase I/II con scAAV9.U1a.hSGSH para la Mucopolisacaridosis (MPS) tipo IIIA

  • Protocol code: ABT-001
  • EudraCT code: 2015-003904-21
  • Pathology: Mucopolysaccharidosis type IIIA
  • Pharmac: ScAAV9.U1a.hSGSH
  • Promoter: Abeona Therapeutics
  • Principal investigator:  Del Toro Riera, Mireia
  • Research group:  Neurologia infantil
  • Service: Neurologia pediàtrica
  • Phase: Phase II
  • Recruiting: Closed
  • Status: Finalizado

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Estudio multicéntrico de fase?3, aleatorizado, controlado con placebo, doble ciego, para evaluar la eficacia y la seguridad del pegcetacoplán en pacientes con glomerulopatía C3 primaria o glomerulonefritis membranoproliferativa mediada por inmunocomplejos

  • Protocol code: APL2-C3G-310
  • EudraCT code: 2020-003767-25
  • Pathology: Glomerulopatía C3 primaria o glomerulonefritis membranoproliferativa mediada por inmunocomplejos
  • Pharmac: Pegcetacoplan
  • Promoter: Apellis Pharmaceuticals
  • Principal investigator:  Ariceta Iraola, Gema
  • Research group:  Kidney Physiopathology
  • Service: Pediatric Nephrology
  • Phase: Phase III
  • Recruiting: Closed
  • Status: Cerrado

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Ensayo abierto de seguridad y tolerabilidad a largo plazo de nintedanib oral, añadido al tratamiento estándar, durante al menos 2 años, en niños y adolescentes con Enfermedad Pulmonar Intersticial fibrosante clínicamente significativa (InPedILD™-ON)

  • Protocol code: 1199-0378
  • EudraCT code: 2020-005554-23
  • Pathology: Enfermedad Pulmonar Intersticial
  • Pharmac: Nintedanib
  • Promoter: Boehringer Ingelheim España, S.A
  • Principal investigator:  Moreno Galdó, Antonio
  • Research group:  Growth and Development
  • Service: Al·lergologia i Pneumologia pediàtrica
  • Phase: Phase III
  • Recruiting: Closed
  • Status: Cerrado

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Rights: You can access, rectify, delete your data, oppose or limit its processing and request its portability, as well as revoke your consent without retroactive effects by contacting lopd@vhir.org. The revocation of consent and the opposition to the processing of your data will prevent the purpose from being carried out. DPO: dpd@ticsalutsocial.org. More information 
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Estudio de fase II abierto y multicéntrico para evaluar la seguridad, farmacocinética y eficacia de Nedosiran en pacientes pediátricos desde el nacimiento hasta los 5 años de edad con hiperoxaluria primaria y función renal relativamente intacta

  • Protocol code: DCR-PHXC-203
  • EudraCT code: 2021-001083-16
  • Pathology: Hiperoxaluria Primaria
  • Pharmac: Nedosiran
  • Promoter: Dicerna Pharmaceuticals
  • Principal investigator:  Ariceta Iraola, Gema
  • Research group:  Kidney Physiopathology
  • Service: Pediatric Nephrology
  • Phase: Phase II
  • Recruiting: Closed
  • Status: Cerrado

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Rights: You can access, rectify, delete your data, oppose or limit its processing and request its portability, as well as revoke your consent without retroactive effects by contacting lopd@vhir.org. The revocation of consent and the opposition to the processing of your data will prevent the purpose from being carried out. DPO: dpd@ticsalutsocial.org. More information 
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Estudio de continuación abierto para evaluar la seguridad y eficacia a largo plazode la solución inyectable DCR-PHXC (uso subcutáneo) en pacientes conhiperoxaluria primaria

  • Protocol code: DCR-PHXC-301
  • EudraCT code: 2018-003099-10
  • Pathology: Primary Hyperoxaluria
  • Pharmac: DCR PHXC Solution for Injection (subcutaneous use)
  • Promoter: Dicerna Pharmaceuticals
  • Principal investigator:  Ariceta Iraola, Gema
  • Research group:  Kidney Physiopathology
  • Service: Pediatric Nephrology
  • Phase: Phase II
  • Recruiting: Open
  • Status: Activo

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Estudio aleatorizado, con enmascaramiento doble y comparativo con un placebo, en el que se evalúa galcanezumab en pacientes adolescentes de entre 12 y 17 años con migraña crónica - Estudio REBUILD-2

  • Protocol code: I5Q-MC-CGAT
  • EudraCT code: 2018-004622-28
  • Pathology: Migraña
  • Pharmac: Galcanezumab
  • Promoter: Eli Lilly
  • Principal investigator:  Pozo Rosich, Patricia
  • Research group:  Cefalea i dolor neurològic
  • Service: Neurology
  • Phase: Phase III
  • Recruiting: Open
  • Status: Activo

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Rights: You can access, rectify, delete your data, oppose or limit its processing and request its portability, as well as revoke your consent without retroactive effects by contacting lopd@vhir.org. The revocation of consent and the opposition to the processing of your data will prevent the purpose from being carried out. DPO: dpd@ticsalutsocial.org. More information 
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Estudio aleatorizado, con enmascaramiento doble y comparativo con un placebo,en el que se evalúa galcanezumab en pacientes de entre 6 y 17 años con migrañaepisódica - Estudio REBUILD-1

  • Protocol code: I5Q-MC-CGAS
  • EudraCT code: 2017-004351-23
  • Pathology: Migraña
  • Pharmac: Galcanezumab
  • Promoter: Eli Lilly
  • Principal investigator:  Pozo Rosich, Patricia
  • Research group:  Headache and Neurological Pain
  • Service: Neurology
  • Phase: Phase III
  • Recruiting: Open
  • Status: Activo

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Controller: Fundació Hospital Universitari Vall Hebron Institut de Recerca – VHIR- G60594009.
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Estudio prospectivo, aleatorizado, abierto, multicéntrico para evaluar los beneficios y riesgos de la conversión de receptores adolescentes de aloinjerto renal existente desde 12 años hasta menos de 18 años de edad a un régimen inmunosupresor con Belatacept en comparación con la continuación con un régimen con un inhibidor de la calcineurina y su cumplimiento con las medicaciones inmunosupresoras

  • Protocol code: IM103-402
  • EudraCT code: 2018-000237-12
  • Pathology: Adolescent Renal Allografts
  • Pharmac: Belatacept-based Immunosuppressive Regimen
  • Promoter: Bristol-Myers Squibb
  • Principal investigator:  Ariceta Iraola, Gema
  • Research group:  Kidney Physiopathology
  • Service: Pediatric Nephrology
  • Phase: Phase III
  • Recruiting: Closed
  • Status: Cerrado

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Controller: Fundació Hospital Universitari Vall Hebron Institut de Recerca – VHIR- G60594009.
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Estudio en fase II abierto para evaluar la seguridad y eficacia de DCR-PHXC en pacientes con Hiperoxaluria primaria tipo 1 o 2 e insuficiencia renal grave con o sin diálisis

  • Protocol code: DCR-PHXC-204
  • EudraCT code: 2020-002826-97
  • Pathology: Primary Hyperoxaluria
  • Pharmac: DCR-PHXC
  • Promoter: Dicerna Pharmaceuticals
  • Principal investigator:  Ariceta Iraola, Gema
  • Research group:  Kidney Physiopathology
  • Service: Pediatric Nephrology
  • Phase: Phase II
  • Recruiting: Closed
  • Status: Finalizado

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Controller: Fundació Hospital Universitari Vall Hebron Institut de Recerca – VHIR- G60594009.
Purpose: Request for information on VHIR clinical research.
Legitimation: Your consent. The data requested is necessary and your request cannot be processed if you do not provide them.
Transfers: Your data will not be transferred to third parties except to the Principal Investigator who leads the research in order to be able to respond to your query.
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Rights: You can access, rectify, delete your data, oppose or limit its processing and request its portability, as well as revoke your consent without retroactive effects by contacting lopd@vhir.org. The revocation of consent and the opposition to the processing of your data will prevent the purpose from being carried out. DPO: dpd@ticsalutsocial.org. More information 
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Ensayo clínico de viabilidad de la combinación de AloCelyvir con quimioterapia y radioterapia para el tratamiento de niños y adolescentes con tumores sólidos extra-craneales en recaída o refractarios.

  • Protocol code: FIBHNJ-2019-01
  • EudraCT code: 2019-001154-26
  • Pathology: Relapsed or refractory extracranial solid tumors in children and adolescents
  • Pharmac: AloCelyvir with chemotherapy and radiotherapy
  • Promoter: FUNDACIÓN DE INVESTIGACIÓN BIOMÉDICA DEL HOSPITAL INFANTIL UNIVERSITARIO NIÑO JESÚS
  • Principal investigator:  Moreno Martín-Retortillo, Lucas
  • Research group:  Childhood Cancer and Blood Disorders
  • Service: Pediatric Oncohematology
  • Phase: Phase I
  • Recruiting: Open
  • Status: Activo

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I have read and accept the data protection policy *.
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Controller: Fundació Hospital Universitari Vall Hebron Institut de Recerca – VHIR- G60594009.
Purpose: Request for information on VHIR clinical research.
Legitimation: Your consent. The data requested is necessary and your request cannot be processed if you do not provide them.
Transfers: Your data will not be transferred to third parties except to the Principal Investigator who leads the research in order to be able to respond to your query.
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Rights: You can access, rectify, delete your data, oppose or limit its processing and request its portability, as well as revoke your consent without retroactive effects by contacting lopd@vhir.org. The revocation of consent and the opposition to the processing of your data will prevent the purpose from being carried out. DPO: dpd@ticsalutsocial.org. More information 
The request for information on a research project or clinical trial does not entail inclusion in it.