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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: 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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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:  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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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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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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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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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: Fase 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:  Creixement i desenvolupament
  • Service: Endocrinologia pediàtrica
  • Phase: Fase 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:  Fisiopatologia renal
  • Service: Nefrologia 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.
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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.

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