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A 2-Part, Randomized, Double-Blind, Placebo-Controlled Study in Participants with Duchenne Muscular Dystrophy Amenable to Exon 44 Skipping to Evaluate the Safety and Efficacy of ENTR-601-44 (ELEVATE-44)

  • Protocol code: ENTR-601-44-201
  • EudraCT code: 2024-517584-23-00
  • Pathology: Duchenne muscular dystrophy
  • Pharmac: Hydrocortisone
  • Promoter: Entrada Theraputics, Inc.
  • Principal investigator:  Gómez Andrés, David
  • Research group:  Teràpies i Innovació en Neuropediatria i altres malalties rares pediàtriques.
  • Service: Neurologia pediàtrica
  • Phase: Fase I
  • Recruiting: Open
  • Status: Activo

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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 tolerabilidad y aceptación de dos fórmulas magistrales de hidrocortisona oral para pediatría

  • Protocol code: HIDROGUM21
  • EudraCT code: 2021-001069-20
  • Pathology: Adrenal hyperplasia or isolated primary adrenal insufficiency or panhypopituitarism (secondary or tertiary adrenal insufficiency).
  • Promoter: Hospital Universitario Vall Hebron
  • Principal investigator:  Parramon Teixido, Carlos Javier
  • Research group:  Recerca en farmacia bàsica, translacional i clínica
  • Service: Farmàcia
  • Phase: Fase IV
  • 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.

Recombination Chimeric Monoclonal Antibody CH.14.18

  • Protocol code: SIOPENRNET002
  • EudraCT code: 2006-001489-17
  • Pathology: Neuroblastoma
  • Pharmac: Anticuerpo monoclonal recombinante antiGDch14.18.
  • Promoter: Dra. Victoria Castel (Hospital La Fe de Valencia)
  • Principal investigator:  Moreno Martín-Retortillo, Lucas
  • Research group:  Càncer i malalties hematològiques infantils
  • Service: Oncohematologia 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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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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A phase III, Multicenter, Randomized, Double-blind Study to Assess Efficacy and Safety of Two Doses of Crizanlizumab versus placebo, with or without Hydroxyurea/ Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients with Vaso-Occlusive Crises (STAND)

  • Protocol code: CSEG101A2301
  • EudraCT code: 2017-001746-10
  • Pathology: Sickle cell disease
  • Pharmac: Crizanlizumab
  • Promoter: Novartis Pharma AG
  • Principal investigator:  Beneitez Pastor, David
  • Research group:  VHIO (Grups bàsics i clínics)
  • Service: Hematologia
  • 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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Estudio en fase III, aleatorizado, abierto, con control activo, multicéntrico, para evaluar la eficacia y la seguridad de crovalimab frente a eculizumab en pacientes adultos y adolescentes con hemoglobinuria paroxística nocturna (HPN) actualmente tratada con inhibidores del complemento

  • Protocol code: BO42161
  • EudraCT code: 2020-000597-26
  • Pathology: Paroxysmal Nocturnal Hemoglobinuria (PNH)
  • Pharmac: CROVALIMAB
  • Promoter: F. Hoffmann-La Roche AG (Switzerland)
  • Principal investigator:  Beneitez Pastor, David
  • Research group:  VHIO (Grups bàsics i clínics)
  • Service: Hematologia
  • 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 de fase 3, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos con una extensión abierta para evaluar la eficacia y la seguridad de rilzabrutinib por vía oral (PRN1008) en adultos y adolescentes con trombocitopenia inmunitaria (TPI) persistente o crónica

  • Protocol code: PRN1008-018
  • EudraCT code: 2020-002063-60
  • Pathology: Immune Thrombocytopenia (ITP)
  • Pharmac: Rilzabrutinib (PRN1008)
  • Promoter: Principia Biopharma Inc. (United States)
  • Principal investigator:  Valcarcel Ferreiras, David
  • Research group:  VHIO (Grups bàsics i clínics)
  • Service: Hematologia
  • 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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Ensayo multinacional, abierto, aleatorizado y controlado para investigar la eficacia y la seguridad de NNC0365-3769 (Mim8) en adultos y adolescentes con hemofilia A con o sin inhibidores

  • Protocol code: NN7769-4514
  • EudraCT code: 2020-001048-24
  • Pathology: Hemofilia A con inhibidores
  • Pharmac: NNC0365-3769 (Mim8)
  • Promoter: Novo Nordisk A/S
  • Principal investigator:  Benitez Hidalgo, Olga
  • Research group:  VHIO (Grups bàsics i clínics)
  • Service: Hematologia
  • Phase: Fase III
  • Recruiting: Closed
  • Status: Cerrado

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Estudio abierto para investigar la eficacia, la seguridad y la farmacocinética de la profilaxis con concizumab en niños menores de 12 años con hemofilia A o B con o sin inhibidores

  • Protocol code: NN7415-4616
  • EudraCT code: 2020-000504-11
  • Pathology: Haemophilia A or B with or without inhibitors
  • Pharmac: Concizumab
  • Promoter: Novo Nordisk A/S
  • Principal investigator:  Benitez Hidalgo, Olga
  • Research group:  VHIO (Grups bàsics i clínics)
  • Service: Hematologia
  • Phase: Fase III
  • Recruiting: Open
  • Status: Activo

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A phase 3b open-label, multicenter study evaluating physicalactivity and joint health in previously treated patients =12 years of age with severehaemophilia A treated with intravenous recombinant coagulation factor VIII FcvonWillebrand Factor-XTEN fusion protein (rFVIIIFc-VWF-XTEN; efanesoctocogalfa) for 24 months.

  • Protocol code: BIVV001-001
  • EudraCT code: 2022-500275-31-00
  • Pathology: Haemophilia A
  • Pharmac: Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001)
  • Promoter: Swedish Orphan Biovitrum AB (publ) (Sweden)
  • Principal investigator:  Benitez Hidalgo, Olga
  • Research group:  VHIO (Grups bàsics i clínics)
  • Service: Hematologia
  • 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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Estudio de dosis escalonadas para evaluar la farmacocinética, eficacia y seguridad de apotransferrina en pacientes con atransferrinemia.

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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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