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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.
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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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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 
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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.
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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 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.
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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 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.
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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 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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A phase 3, open-label study of adjunctive ganaxolone (GNX) treatment in children and adults with tuberous sclerosis complex (TSC)-related epilepsy (TrustTSC OLE)

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Estudio en fase I/II, abierto, de seguridad, tolerabilidad, farmacocinética y actividad antitumoral de repotrectinib en pacientes pediátricos y adultos jóvenes con tumores avanzados o metastásicos con reordenaciones de ALK, ROS1 o NTRK1-3 (CARE)

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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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An Open-Label, Single-Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Adolescent Subjects with Moderately to Severely Active Ulcerative Colitis

  • Protocol code: APD334-207
  • EudraCT code: 2022-500345-25-00
  • Pathology: Moderately to severely active ulcerative colitis
  • Pharmac: Etrasimod
  • Promoter: Arena Pharmaceuticals
  • Principal investigator:  Segarra Canton, Oscar
  • Research group:  No té grup assignat
  • Service: Gastroenterologia pediàtrica
  • Phase: Fase II
  • 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 
The request for information on a research project or clinical trial does not entail inclusion in it.

Estudio abierto sobre la seguridad y la eficacia del cenobamato (YKP3089) en pacientes pediátricos con crisis de inicio parcial (focales)

  • Protocol code: YKP3089C040
  • EudraCT code: 2020-005344-27
  • Pathology: Partial-onset (focal) seizures
  • Pharmac: Cenobamate (YKP3089)
  • Promoter: SK Life Science
  • Principal investigator:  Raspall Chaure, Miquel
  • 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.
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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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