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Estudio de fase 3b, multicéntrico y abierto, de la seguridad, tolerabilidad y eficacia del tolvaptán en lactantes de 28 días a menos de 12 semanas de edad con poliquistosis renalautosómica recesiva (ARPKD)

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  • Protocol code: 156-12-204
  • EudraCT code: 2020-005991-36
  • Pathology: Autosomal Recessive Polycystic Kidney Disease
  • Pharmac: Tolvaptan
  • Promoter: Otsuka Pharmaceutical
  • Principal investigator:  Ariceta Iraola, Gema
  • Research group:  Fisiopatologia renal
  • Service: Nefrologia Pediàtrica
  • Phase: Fase III
  • 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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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, controlado con placebo, de dosis escalonadas múltiples para evaluar la seguridad, la tolerabilidad, la farmacodinámica, la eficacia y la farmacocinética de DYNE-251 administrado a pacientes con distrofia muscular de Duchenne susceptibles de omisión del exón 51.

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  • Protocol code: DYNE251-DMD-201
  • EudraCT code: 2021-005478-24
  • Pathology: Duchenne muscular dystrophy
  • Pharmac: DYNE-251
  • Promoter: Dyne Therapeutics, Inc., a Delaware corporation
  • Principal investigator:  Munell Casadesus, Francina
  • Research group:  Neurologia infantil
  • Service: Neurologia pediàtrica
  • Phase: Fase 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.
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 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

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  • 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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Legitimation: Your consent. The data requested is necessary and your request cannot be processed if you do not provide them.
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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.

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

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  • 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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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 
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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)

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  • 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: Fase II
  • 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 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.

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  • 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:  Creixement i desenvolupament
  • Service: Al·lergologia i Pneumologia pediàtrica
  • Phase: Fase II
  • Recruiting: Closed
  • Status: Finalizado

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Controller: Fundació Hospital Universitari Vall Hebron Institut de Recerca – VHIR- G60594009.
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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 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

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  • 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: Fase III
  • Recruiting: Closed
  • Status: Cerrado

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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 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

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  • 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:  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.
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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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

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Controller: Fundació Hospital Universitari Vall Hebron Institut de Recerca – VHIR- G60594009.
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The request for information on a research project or clinical trial does not entail inclusion in it.
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