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Estudio de fase II/III, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia, la seguridad, la tolerabilidad, la farmacocinética y la farmacodinámica del ácido obeticólico en comparación con placebo después de la hepatoportoenterostomía en pacientes pediátricos con atresia biliar

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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 
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, de grupos paralelos y controlado con placebo de la eficacia y la seguridad de tezepelumab en niños de 5 a <12 años con asma grave no controlada (HORIZON)

  • Protocol code: D5180C00016
  • EudraCT code: 2022-502984-39-00
  • Pathology: Severe Uncontrolled Asthma
  • Pharmac: Tezepelumab
  • Promoter: AstraZeneca
  • Principal investigator:  de Mir Messa, Inés
  • Research group:  Creixement i desenvolupament
  • Service: 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 
The request for information on a research project or clinical trial does not entail inclusion in it.

LIGHTBEAM-U01 Subestudio 01A: Subestudio de fase 1/2 para evaluar la seguridad y la eficacia de zilovertamab vedotina en participantes pediátricos y adultos jóvenes con neoplasias malignas hematológicas o tumores sólidos

  • Protocol code: MK-9999-01A
  • EudraCT code: 2023-507178-41-00
  • Pathology: Hematologic Malignancies or Solid Tumors in Pediatric and Young Adults
  • Pharmac: Zilovertamab vedotina
  • Promoter: Merck Sharp & Dohme Corp.
  • Principal investigator:  Hladun Alvaro, Raquel
  • Research group:  Càncer i malalties hematològiques infantils
  • Service: Oncohematologia Pediàtrica
  • Phase: Fase I
  • 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 
The request for information on a research project or clinical trial does not entail inclusion in it.

Estudio de extensión de fase IV, multicéntrico y abierto para pacientes conenfermedad de células falciformes que hayan completado un estudio anterior de crizanlizumab promocionado por Novartis.

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

A phase 3, randomized, double-blind, placebo-controlled, parallel-arm study to evaluate the efficacy and safety of RZ358 in patients with congenital hyperinsulinism.

  • Protocol code: RZ358-301
  • EudraCT code: 2023-503240-13-00
  • Pathology: Hypoglycemia associated with congenital hyperinsulinism
  • Pharmac: RZ358
  • Promoter: Rezolute, Inc.
  • Principal investigator:  Clemente Leon, Maria
  • Research group:  Creixement i desenvolupament
  • Service: Endocrinologia pediàtrica
  • Phase: Fase III
  • 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.

An Open-Label Extension to Investigate the Long-Term Safety, Tolerability, and Efficacy of DNL310 in Patients With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007

  • Protocol code: DNLI-E-0008
  • EudraCT code: 2023-503837-23-00
  • Pathology: Mucopolysaccharidosis Type II
  • Pharmac: Tividenofusp Alfa (DNL310)
  • Promoter: Denali therapeutics Inc.
  • Principal investigator:  Del Toro Riera, Mireia
  • Research group:  Neurologia infantil
  • Service: Neurologia 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 
The request for information on a research project or clinical trial does not entail inclusion in it.

ESTUDIO MULTICENTRO DE CONTINUACIÓN EN DOS PARTES, ALEATORIZADO, CONTROLADO CON PLACEBO, DOBLE CIEGO PARA INVESTIGAR LA SEGURIDAD, TOLERABILIDAD, FARMACOCINÉTICA, FARMACODINÁMICA Y EFICACIA DE RO7204239 EN COMBINACIÓN CON RISDIPLAM (RO7034067) EN PACIENTES CON ATROFIA MUSCULAR ESPINAL

  • Protocol code: BN42644
  • EudraCT code: 2021-003417-19
  • Pathology: Spinal Muscular Atrophy (SMA)
  • Pharmac: RO7204239 IN COMBINATION WITH RISDIPLAM (RO7034067)
  • Promoter: ROCHE
  • Principal investigator:  Gómez Andrés, David
  • Research group:  Teràpies i Innovació en Neuropediatria i altres malalties rares pediàtriques.
  • Service: Neurologia 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.
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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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A SINGLE-ARM, OPEN-LABEL, MULTI-CENTRE, PHASE IB STUDY EVALUATING THE SAFETY AND PRELIMINARY EFFICACY OF AUTO1 IN PAEDIATRIC PATIENTS WITH CD19-POSITIVE RELAPSED/ REFRACTORY (R/R) B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (B ALL) AND AGGRESSIVE MATURE B-CELL NON-HODGKIN LYMPHOMA (B NHL)

  • Protocol code: AUTO1-PY1
  • EudraCT code: 2023-506307-26-00
  • Pathology: B-cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL).
  • Pharmac: Aucatzyl
  • Promoter: Autolus Ltd
  • Principal investigator:  Díaz de Heredia Rubio, Maria Cristina
  • Research group:  Càncer i malalties hematològiques infantils
  • Service: Oncohematologia Pediàtrica
  • Phase: Fase I
  • 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.
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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A study evaluating the safety and efficacy of once-weekly dosing of somapacitan in a basket study design in paediatric participants with short stature either born small for gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature.

  • Protocol code: NN8640-4469
  • EudraCT code: 2022-501055-87-01
  • Pathology: Small for gestational age / Idiopathic short stature / Noonan syndrome / Turners syndrome
  • Pharmac: Somapacitan
  • Promoter: Novo Nordisk
  • Principal investigator:  Mogas Viñas, Eduard
  • Research group:  Creixement i desenvolupament
  • Service: Endocrinologia pediàtrica
  • Phase: Fase III
  • 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 
The request for information on a research project or clinical trial does not entail inclusion in it.

Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de iptacopán (LNP023) en la glomerulopatía C3.

  • Protocol code: CLNP023B12301
  • EudraCT code: 2020-004589-21
  • Pathology: Complement 3 glomerulopathy
  • Pharmac: Iptacopan (LNP023)
  • Promoter: Novartis
  • 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.
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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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