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ESTUDIO EN FASE IIIB SIN ENMASCARAMIENTO PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DEL TRATAMIENTO CON LEBRIKIZUMAB EN ADULTOS Y ADOLESCENTES CON DERMATITIS ATÓPICA DE MODERADA A GRAVE.

  • Protocol code: M-17923-34
  • EudraCT code: 2023-508235-31-00
  • Pathology: Atopic Dermatitis
  • Pharmac: Lebrikizumab
  • Promoter: Almirall S.A.
  • Principal investigator:  Aparicio Español, Gloria
  • Research group:  No té grup assignat
  • Service: Dermatologia
  • 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 en fase II, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de 12 semanas de tratamiento y de 3 brazos grupos paralelos para investigar la eficacia, la seguridad y la tolerabilidad de ro7017773 en participantes de 15 a 45 años de edad con trastorno del espectro autista (tea).

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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 fase II, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de la pimavanserina para el tratamiento de la irritabilidad asociada al trastorno del espectro autista.

  • Protocol code: ACP-103-069
  • EudraCT code: 2021-005387-22
  • Pathology: Tratamiento de la irritabilidad asociada al trastorno autista en niños y adolescentes con TEA.
  • Pharmac: Pimavanserin
  • Promoter: Acadia
  • Principal investigator:  Gisbert Gustemps, Laura
  • Research group:  Psychiatry, Mental Health and Addictions
  • Service: Psychiatry
  • Phase: Phase 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.
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 tipo umbrella de fase IIa, multicéntrico, aleatorizado, doble ciego, controlado con placebo y detratamiento con grupos paralelos para evaluar la eficacia y la seguridad de frexalimab, SAR442970 yrilzabrutinib en participantes de 16 a 75 años con glomeruloesclerosis focal segmentaria (GEFS) primaria oenfermedad de cambios mínimos (ECM)

  • Protocol code: ACT18064
  • EudraCT code: 2024-511775-15-00
  • Pathology: Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
  • Pharmac: Frexalimab, SAR442970, or Rilzabrutinib
  • Promoter: Sanofi
  • Principal investigator:  Soler Romeo, Maria Jose
  • Research group:  Nefrologia i trasplantament renal
  • Service: Nefrologia
  • Phase: Phase 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.
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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A phase I/II trial of ABTL0812 in children with relapsed/refractory neuroblastoma and other solid tumour

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

Estudio de seguimiento a largo plazo de pacientes con MPS IIIA procedentes de ensayos clínicos de terapia génica que incluyen la administración de ABO-102 (scAAV9.U1a.hSGSH)

  • Protocol code: LTFU-ABO-102
  • EudraCT code: 2019-002979-34
  • Pathology: Mucopolysaccharidosis type IIIA
  • Pharmac: ABO-102 (scAAV9.U1a.hSGSH)
  • Promoter: Ultragenyx Pharmaceutical Inc
  • Principal investigator:  Del Toro Riera, Mireia
  • Research group:  Neurologia infantil
  • Service: Neurologia pediàtrica
  • 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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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 de extensión de seguridad de 18 meses, abierto y de un solo brazo, de un régimen de finerenona oral, ajustado por edad y peso corporal, añadido a un IECA o ARA II para el tratamiento de pacientes pediátricos y adultos jóvenes de 1 a 18 años con enfermedad renal crónica y proteinuria.

  • Protocol code: 20186
  • EudraCT code: 2021-002905-89
  • Pathology: Treatment of children with chronic kidney disease and proteinuria
  • Pharmac: Finerenone
  • Promoter: Bayer
  • Principal investigator:  Ariceta Iraola, Gema
  • Research group:  Fisiopatologia renal
  • Service: Nefrologia Pediàtrica
  • 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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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 fase 3, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad de erenumab en niños (de 6 a < 12 años) y adolescentes (de 12 a < 18 años) con migraña episódica (OASIS PEDIATRIC [EM])

  • Protocol code: 20150125
  • EudraCT code: 2017-002397-39
  • Pathology: Episodic Migraine
  • Pharmac: Erenumab
  • Promoter: Amgen
  • Principal investigator:  Pozo Rosich, Patricia
  • Research group:  Cefalea i dolor neurològic
  • Service: Neurologia
  • Phase: Phase 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 de extensión, abierto, multicéntrico y de un solo grupo para evaluar la seguridad a largo plazo de GSK3511294 (depemokimab) en participantes adultos y adolescentes con asma grave con fenotipo eosinofílico de los estudios 206713 o 213744

  • Protocol code: 212895
  • EudraCT code: 2020-004334-38
  • Pathology: Severe asthma with an eosinophilic phenotype
  • Pharmac: GSK3511294 (Depemokimab)
  • Promoter: GlaxoSmithKline
  • Principal investigator:  Garriga Baraut, Maria Teresa
  • Research group:  Creixement i desenvolupament
  • Service: Al·lergologia i Pneumologia 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.
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 multicéntrico, aleatorizado, doble ciego y controlado con placebo de 6 meses para evaluar la eficacia, seguridad y la farmacocinética y farmacodinámica de un régimen de finerenona oral ajustado por edad y peso corporal, añadido a un IECA o ARA II, para el tratamiento de pacientes pediátricos, de 6 meses a <18 años, con enfermedad renal crónica y proteinuria

  • Protocol code: 19920
  • EudraCT code: 2021-002071-19
  • Pathology: Chronic kidney disease / Proteinuria
  • Pharmac: Finerenone
  • Promoter: Bayer
  • Principal investigator:  Ariceta Iraola, Gema
  • Research group:  Kidney Physiopathology
  • Service: Pediatric Nephrology
  • 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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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 
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Estudio de fase 3 multicéntrico, doble ciego, aleatorizado, controlado con placebo y de grupos paralelos, seguido de una fase de tratamiento activo para evaluar la eficacia y seguridad de apremilast en niños de 2 a menos de 18 años con úlceras bucales activas asociadas a la enfermedad de Behçet (BEAN).

  • Protocol code: 20190530
  • EudraCT code: 2019-002787-27
  • Pathology: Oral ulcers associated with Behçets Disease / Behcet's disease
  • Pharmac: Apremilast
  • Promoter: Amgen
  • Principal investigator:  Moreno Ruzafa, Estefania
  • Research group:  Reumatologia
  • Service: Reumatologia pediàtrica
  • Phase: Phase 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 
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Estudio de fase 3 multicéntrico, doble ciego, aleatorizado, controlado con placebo y de grupos paralelos para evaluar la eficacia, seguridad y farmacocinética de apremilast en niños de 5 a menos de 18 años de edad con artritis psoriásica juvenil activa (PEAPOD, por sus siglas in inglés)

  • Protocol code: 20190529
  • EudraCT code: 2019-002788-88
  • Pathology: Juvenile psoriatic arthritis
  • Pharmac: Apremilast
  • Promoter: Amgen
  • Principal investigator:  Moreno Ruzafa, Estefania
  • Research group:  Rheumatology
  • Service: Reumatologia pediàtrica
  • Phase: Phase 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 de fase 1, multicéntrico, abierto, con intensificación de dosis y expansión de cohorte con Niraparib y Dostarlimab en pacientes pediátricos con tumores sólidos recurrentes o refractarios

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

Estudio clínico de fase 2/3, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia, la seguridad y la farmacocinética del Vericiguat en pacientes pediátricos con insuficiencia cardíaca debido a disfunción sistólica sistémica del ventrículo izquierdo

  • Protocol code: MK-1242-036
  • EudraCT code: 2022-501238-52-00
  • Pathology: Heart failure due to systemic left ventricular systolic dysfunction
  • Pharmac: Vericiguat
  • Promoter: Merck Sharp & Dohme LLC.
  • Principal investigator:  Rosés i Noguer, Ferran
  • Research group:  No té grup assignat
  • Service: Cardiologia Pediàtrica
  • 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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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 Multi-center, Randomized, Double-blind, Placebo-controlled Trial toEvaluate the Neurological Effects of EryDex on subjects with Ataxia Telangiectasia

  • Protocol code: IEDAT-04-2022
  • EudraCT code: 2023-509077-23-00
  • Pathology: Ataxia Telangiectasia
  • Pharmac: EryDex
  • Promoter: BIOTRIAL PARIS SAS
  • Principal investigator:  Gómez Andrés, David
  • Research group:  Teràpies i Innovació en Neuropediatria i altres malalties rares pediàtriques.
  • Service: Neurologia pediàtrica
  • Phase: Phase III
  • Recruiting: Closed
  • Status: Finalizado

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Estudio de fase 3 multicéntrico para evaluar la eficacia,seguridad y farmacocinética de la inducción de upadacitinib en régimen abierto,aleatorizado, mantenimiento doble ciego y extensión abierta a largo plazo ensujetos pediátricos con colitis ulcerosa activa de moderada a severa y conrespuesta insuficiente, intolerancia o contraindicaciones médicas al tratamientocon corticosteroides, inmunosupresores o terapias biológicas.

  • Protocol code: M14-658
  • EudraCT code: 2022-501788-41-00
  • Pathology: Ulcerative Colitis
  • Pharmac: Upadacitinib
  • Promoter: abbvie
  • Principal investigator:  Segarra Canton, Oscar
  • Research group:  No té grup assignat
  • Service: Gastroenterologia pediàtrica
  • Phase: Phase 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 
The request for information on a research project or clinical trial does not entail inclusion in it.

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.
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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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Data retention time: As long as they are useful for the purpose for which they were collected and responsibilities may arise.
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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:  Growth and Development
  • Service: Pneumologia pediàtrica
  • 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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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:  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.
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 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.
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.