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Estudio de fase 2 de la infusión de células T autólogas, diferenciadas y de sangre periférica expandidas y transducidas con un lentivirus para expresar un receptor de antígeno quimérico con especificidad anti-CD19 (A3B1) junto con regiones coestimuladoras 4-1BB y CD3z (ARI- 0001 células) en niños y adolescentes (de 0 a 18 años) con leucemia linfoblástica aguda CD19+ resistente o refractaria al tratamiento

  • Protocol code: CART19-BE-03PED
  • EudraCT code: 2022-001101-52
  • Pathology: Acute lymphoblastic leukemia
  • Pharmac: Autologous, differentiated, peripheral blood T-cells expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity (A3B1) coupled with 4-1BB and CD3z co-stimulatory regions (ARI-0001 cells)
  • Promoter: Fundació Sant Joan de Déu
  • Principal investigator:  Díaz de Heredia Rubio, Maria Cristina
  • Research group:  Càncer i malalties hematològiques infantils
  • Service: Oncohematologia Pediàtrica
  • Phase: Fase II
  • Recruiting: Open
  • Status: Activo

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Controller: Fundació Hospital Universitari Vall Hebron Institut de Recerca – VHIR- G60594009.
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Evaluación de la eficacia y seguridad de la inmunoterapia subcutánea (Beltavac®) con extracto alergénico polimerizado de mezcla de ácaros del polvo en pacientes con rinitis/rinoconjuntivitis alérgica

  • Protocol code: PRO-RCT-ACAROS-2018-01
  • EudraCT code: 2018-003427-11
  • Pathology: Allergic rhinoconjunctivitis due to exposure of house dust mites
  • Pharmac: Subcutaneous immunotherapy (Beltavac®)
  • Promoter: Probeltepharma
  • Principal investigator:  Garriga Baraut, Maria Teresa
  • Research group:  Creixement i desenvolupament
  • Service: Al·lergologia i Pneumologia pediàtrica
  • Phase: Fase III
  • Recruiting: Open
  • Status: Activo

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Estudio de extensión, abierto de 52 semanas para evaluar la pimavanserina en niños y adolescentes con irritabilidad asociada al trastorno del espectro autista (TEA)

  • Protocol code: ACP-103-070
  • EudraCT code: 2021-005388-32
  • Pathology: Irritability associated with autistic disorder in children and adolescents with ASD
  • Pharmac: Pimavanserin
  • Promoter: Acadia
  • Principal investigator:  Gisbert Gustemps, Laura
  • Research group:  Psiquiatria, salut mental i addiccions
  • Service: Psiquiatria
  • Phase: Phase II
  • Recruiting: Closed
  • Status: Cerrado

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Estudio de fase 2 abierto para evaluar la seguridad, tolerabilidad, farmacocinética y farmacodinámica de sotatercept (MK-7962) en niños de entre uno y menos de 18 años con HAP que reciben el tratamiento habitual.

  • Protocol code: MK-7962-008
  • EudraCT code: 2022-000478-25
  • Pathology: Pulmonary arterial hypertension
  • Pharmac: Sotatercept (MK-7962)
  • Promoter: Merck Sharp & Dohme
  • Principal investigator:  Moreno Galdó, Antonio
  • Research group:  Growth and Development
  • Service: Al·lergologia i Pneumologia pediàtrica
  • Phase: Phase II
  • Recruiting: Closed
  • Status: Finalizado

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Ensayo de extensión abierto para evaluar la seguridad a largo plazo de KVD900, un inhibidor oral de la calicreína plasmática, para el tratamiento ademanda de las crisis de angioedema en pacientes adolescentes y adultos con angioedema hereditario de tipo I o II

  • Protocol code: KVD900-302
  • EudraCT code: 2021-001176-42
  • Pathology: Hereditary Angioedema Type I or II
  • Pharmac: KVD900 (oral Plasma Kallikrein Inhibitor)
  • Promoter: Kalvista Pharmaceuticals
  • Principal investigator:  Guilarte Clavero, Mar
  • Research group:  Malalties sistèmiques
  • Service: Al·lergologia
  • Phase: Phase III
  • Recruiting: Closed
  • Status: Cerrado

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Estudio de fase I/II multicéntrico en el que se evalúan la eficacia y la seguridad de ribociclib (LEE011) en combinación con topotecán y temozolomida (TOTEM) en pacientes pediátricos con neuroblastoma recidivante o refractario y otros tumores sólidos

  • Protocol code: CLEE011Q12101
  • EudraCT code: 2021-005617-14
  • Pathology: Relapsed or refractory neuroblastoma and other solid tumors (including medulloblastoma, high grade glioma, malignant rhabdoid tumors, and rhabdomyosarcoma)
  • Pharmac: Ribociclib (LEE011) in combination with topotecan and temozolomide (TOTEM)
  • Promoter: Novartis
  • Principal investigator:  Moreno Martín-Retortillo, Lucas
  • Research group:  Childhood Cancer and Blood Disorders
  • Service: Pediatric Oncohematology
  • Phase: Phase II
  • Recruiting: Open
  • Status: Activo

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Odevixibat (A4250) in children with biliary atresia (BOLD-EXT)

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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 no reciben transfusiones con regularidad, seguido de un periodo de extensión abierto de 5 años

  • Protocol code: AG348-C-023
  • EudraCT code: 2021-003333-11
  • Pathology: Pyruvate Kinase Deficiency
  • Pharmac: Mitapivat
  • Promoter: Agios Pharmaceuticals
  • Principal investigator:  Murciano Carrillo, Thaïs
  • Research group:  Childhood Cancer and Blood Disorders
  • Service: Pediatric Oncohematology
  • Phase: Phase III
  • Recruiting: Closed
  • Status: Finalizado

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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:  Growth and Development
  • Service: Al·lergologia i Pneumologia pediàtrica
  • Phase: Phase II
  • Recruiting: Open
  • Status: Activo

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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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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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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

  • Protocol code: AG348-C-022
  • EudraCT code: 2021-003265-36
  • Pathology: Pyruvate Kinase Deficiency
  • Pharmac: Mitapivat
  • Promoter: Agios Pharmaceuticals
  • Principal investigator:  Murciano Carrillo, Thaïs
  • Research group:  Childhood Cancer and Blood Disorders
  • Service: Pediatric Oncohematology
  • Phase: Phase III
  • Recruiting: Closed
  • Status: Finalizado

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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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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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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.
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 
The request for information on a research project or clinical trial does not entail inclusion in it.

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.
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.
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 
The request for information on a research project or clinical trial does not entail inclusion in it.

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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I have read and accept the data protection policy *.
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This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

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.
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 
The request for information on a research project or clinical trial does not entail inclusion in it.

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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I have read and accept the data protection policy *.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

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.
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 
The request for information on a research project or clinical trial does not entail inclusion in it.