Portal de recerca
- Inici
- Projectes i Estudis Clínics
- ESTUDIO DE FASE 3, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE GRUPOS PARALELOS Y DE DISEÑO ADAPTATIVO Y SECUENCIAL POR GRUPOS, CON UN PERÍODO DE EXTENSIÓN ABIERTO, PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE SELEXIPAG COMO COMPLEMENTO DEL TRATAMIENTO DE REFERENCIA EN PACIENTES CON HIPERTENSIÓN PULMONAR TROMBOEMBÓLICA CRÓNICA (HPTEC) INOPERABLE O PERSISTENTE/RECURRENTE DESPUÉS DEL TRATAMIENTO QUIRÚRGICO.
ESTUDIO DE FASE 3, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE GRUPOS PARALELOS Y DE DISEÑO ADAPTATIVO Y SECUENCIAL POR GRUPOS, CON UN PERÍODO DE EXTENSIÓN ABIERTO, PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE SELEXIPAG COMO COMPLEMENTO DEL TRATAMIENTO DE REFERENCIA EN PACIENTES CON HIPERTENSIÓN PULMONAR TROMBOEMBÓLICA CRÓNICA (HPTEC) INOPERABLE O PERSISTENTE/RECURRENTE DESPUÉS DEL TRATAMIENTO QUIRÚRGICO.
Dades bàsiques
- Protocol:
- AC-065B302
- EURDRACT:
- 2018-002823-41
- NCT:
- Centre:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Any inici:
- 2019
- Any de finalització:
- 2022
Documents
- No hi ha documents
Participants
Grups d'Investigació
Finançadors - Promotors
Resultats de l'Assaig Clínic
2019 SEFH National Survey: service portfolio, care activities, education and research in Spain's hospital pharmacy departments.
Pérez-Encinas M; (...); Calleja-Hernández MÁ
Article. 10.7399/fh.11611. 2021
A multicriteria decision analysis (MCDA) applied to three long-term prophylactic treatments for hereditary angioedema in Spain
Zozaya, Neboa; (...); Hidalgo-Vega, Alvaro
Article. 10.33393/grhta.2022.2333. 2022
A Multiple Stakeholder Multicriteria Decision Analysis in Diabetic Macular Edema Management: The MULTIDEX-EMD Study.
de Andrés-Nogales F; (...); Martínez-Olmos J
Article. 10.1007/s41669-020-00201-2. 2020
A new definition and refocus of pharmaceutical care: the Barbate Document
Morillo-Verdugo R; (...); Poveda-Andrés JL
Article. 10.7399/fh.11389. 2020
A rare case of diffuse and bilateral pulmonary uptake in 18 F-FDG PET/CT scan.
Olivan-Sasot, P; (...); Bello-Arques, P
Editorial Material. 10.1016/j.remn.2020.11.007. 2021
A rare case of diffuse and bilateral pulmonary uptake in 18F-FDG PET/CT scan.
Olivan-Sasot, P; (...); Bello-Arques, P
Article. 10.1016/j.remnie.2020.11.002. 2021
Adherence and adverse events of intraperitoneal chemotherapy in optimally debulked ovarian cancer patients: Real-life study.
Ballesta-López O; (...); Poveda-Andrés JL
Article. 10.1177/1078155220915953. 2020
Analysis of chemical contamination by hazardous drugs with BD HD Check(R) system in a tertiary hospital
Valero García S; (...); Poveda Andrés JL
Article. 10.1177/10781552211038518. 2021
Anticoagulant therapy for splanchnic vein thrombosis: an individual patient data meta-analysis.
Candeloro, Matteo; (...); Di Nisio, Marcello
Article. 10.1182/bloodadvances.2022007961. 2022
Baricitinib against severe COVID-19: effectiveness and safety in hospitalised pretreated patients.
Iglesias Gómez R; (...); Poveda Andrés JL
Article. 10.1136/ejhpharm-2021-002741. 2021
Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study.
Fernandez Rivera C; (...); Hernandez D
Article. 10.1111/ctr.14550. 2022
Clinical benefits of a Bayesian model for plasma-derived factor VIII/VWF after one year of pharmacokinetic-guided prophylaxis in severe/moderate hemophilia A patients
Megias-Vericat, JE; (...); Poveda, JL
Article. 10.1016/j.thromres.2021.07.009. 2021
Coagulation disorders and thromboembolic disease in COVID-19: review of current evidence in search of a better approach.
García-Ortega A; (...); Martínez-García MÁ
Review. 10.21037/jtd-20-3062. 2021
Comparison of pharmacokinetic estimates using generic and specific population pharmacokinetic models of plasma-derived factor VIII/VWF using WAPPS-Hemo
Megias-Vericat, JE; (...); Poveda, JL
Meeting Abstract. 2020
Comparison of seven prognostic tools to identify low-risk pulmonary embolism in patients aged <50 years.
Jara-Palomares L; (...); RIETE investigators
Article. 10.1038/s41598-019-55213-8. 2019
Correlation between short-term air pollution exposure and unprovoked lung embolism. Prospective observational (Contamina-TEP Group)
de Miguel-Diez, J; (...); Jara-Palomares, L
Article. 10.1016/j.thromres.2020.04.033. 2020
Corrigendum to "Rivaroxaban or apixaban in fragile patients with acute venous thromboembolism" [Thromb. Res. 193 (2020) 160-165].
Trujillo-Santos, Javier; (...); Monreal, Manuel
Correction. 10.1016/j.thromres.2021.10.019. 2021
Corrigendum to "Rivaroxaban or apixaban in fragile patients with acute venous thromboembolism" [Thromb. Res. 193 (2020) 160-165].
Trujillo-Santos J; (...); RIETE Investigators
Correction. 10.1016/j.thromres.2020.10.001. 2020
COST MINIMIZATION ANALYSIS OF RITUXIMAB BIOSIMILAR VERSUS REFERENCE RITUXIMAB IN THE TREATMENT OF FOLLICULAR LYMPHOMA
Gironella, M.; (...); Oyaguez, I
Meeting Abstract. 2019
COSTS OF THE MANAGEMENT OF HEMOPHILIA A WITH INHIBITORS IN SPAIN
Bonanad, S; (...); Gonzalez-Dominguez, A
Meeting Abstract. 2020
Costs of the management of hemophilia A with inhibitors in Spain
Bonanad, S; (...); Gonzalez-Dominguez, A
Article. 10.33393/grhta.2021.2234. 2021
Cross-Sectional Comparative Study of PK-Guided Switch between Standard Half-Life and Extended Half-Life Factor VIII Products
Eduardo Megias, Juan; (...); Iorio, Alfonso
Meeting Abstract. 10.1182/blood-2019-127946. 2019
Changes in sleep-disordered breathing from the acute to the stable phase of pulmonary embolism and impact of right ventricular dysfunction: preliminary findings of ESAET study
Ortega, AG; (...); Martinez-Garcia, MA
Meeting Abstract. 10.1183/13993003.congress-2020.4974. 2020
Chronic thromboembolic pulmonary hypertension in Spain: a decade of change.
Martinez-Santos, Paula; (...); Escribano-Subias, Pilar
Article. 10.1016/j.recesp.2020.05.037. 2020
Design and rationale for a real-world prospective, multicenter registry of myocardial revascularization failure and secondary revascularization: The REVASEC study.
Salinas P; (...); Escaned J
Article. 10.1016/j.carrev.2021.11.015. 2021
Determining the value contribution of emicizumab (Hemlibra (R)) for the prophylaxis of haemophilia A with inhibitors in Spain by multi-criteria decision analysis
Alvarez-Roman, MT; (...); Badia, X
Article. 10.1177/2284240319880534. 2019
DETERMINING THE VALUE OF EMICIZUMAB FOR THE PROPHYLAXIS OF SEVERE HAEMOPHILIA A PATIENTS WITHOUT INHIBITORS IN SPAIN BY MULTI-CRITERIA DECISION ANALYSIS (MCDA)
Alvarez, E.; (...); Badia, F. J.
Meeting Abstract. 2019
DEVELOPMENT AND VALIDATION OF A MCDA FRAMEWORK FOR EVALUATION AND DECISION-MAKING OF ORPHAN DRUGS IN SPAIN
Poveda, J. L.; (...); Vitoria, I
Meeting Abstract. 2019
Development of severity and mortality prediction models for covid-19 patients at emergency department including the chest x-ray
Calvillo-Batllés P; (...); Martí-Bonmatí L
Article. 10.1016/j.rx.2021.09.011. 2022
Development of severity and mortality prediction models for covid-19 patients at emergency department including the chest x-ray.
Calvillo-Batllés P; (...); Martí-Bonmatí L
Article. 10.1016/j.rxeng.2021.09.004. 2022
Efecto de la adición de fortificantes y de módulo de proteínas en la osmolalidad de la leche materna donada.
Torres Martínez E; (...); Vento M
Article. 10.1016/j.anpedi.2020.03.009. 2020
Effect of Prognostic Guided Management of Patients With Acute Pulmonary Embolism According to the European Society of Cardiology Risk Stratification Model.
Jimenez, David; (...); Lobo, Jose Luis
Article. 10.3389/fcvm.2022.872115. 2022
Effectiveness of Caplacizumab Nanobody in Acquired Thrombotic Thrombocytopenic Purpura Refractory to Conventional Treatment
Palanques-Pastor T; (...); Poveda Andrés JL
Article. 10.1159/000517813. 2021
EVALUATING REAL LIFE CRITERIA THAT COULD DRIVE PRICING & REIMBURSEMENT (P&R) APPROVAL OF ORPHAN DRUGS (ODS) IN SPAIN
Badia, F. J.; (...); Shepherd, J.
Meeting Abstract. 2019
EXTENDED MULTICRITERIA DECISION ANALYSIS IN DIABETIC MACULAR EDEMA. MULTIDEX-EMD EXTENSION STUDY
F, de Andres-Nogales; (...); Martinez, M.
Meeting Abstract. 2019
Fetal exposure to tofacitinib during the first trimester: A healthy newborn case report
Fernandez-Sanchez, M; (...); Poveda-Andres, JL
Article. 10.1002/bdr2.1942. 2021
From Health-Related Quality of Life (HRQoL) of Patients with Pulmonary Hypertension to Patient Experience with the Care Received: Should We Be More Aware of Current Patient Needs?
Martínez Meñaca A; (...); Escribano Subías P
Article. 10.1007/s12325-021-01625-w. 2021
Guide to Good Humanization Practices in Patients with Rare Diseases. who vadis
Editorial Material. 2022
Healthcare Resource Utilization among Patients between 60-75 Years with Secondary Acute Myeloid Leukemia Receiving Intensive Chemotherapy Induction: A Spanish Retrospective Observational Study
Solana-Altabella, Antonio; (...); Martinez-Cuadron, David
Article. 10.3390/cancers14081921. 2022
Heart Rate and Mortality in Patients With Acute Symptomatic Pulmonary Embolism.
Jaureguizar, Ana; (...); Registro Informatizado de la Enfermedad TromboEmbolica Investigators
Article. 10.1016/j.chest.2021.08.059. 2021
High incidence of pulmonary thromboembolism in hospitalized SARS-CoV-2 infected patients despite thrombo-prophylaxis.
El-Qutob D; (...); Carrera-Hueso FJ
Article. 10.1016/j.hrtlng.2022.02.003. 2022
Hospital pharmacy initiatives for improving the management of patients with congenital coagulopathies
Bruno Montoro-Ronsano, Jose; (...); Alberto Vella, Vincenzo
Article. 10.7399/fh.11729. 2022
Hospitalization budget impact during the COVID-19 pandemic in Spain.
Carrera-Hueso, F. J.; (...); Crespo-Palomo, C.
Article. 10.1186/s13561-021-00340-0. 2021
Impact of combinations of single-nucleotide polymorphisms of anthracycline transporter genes upon the efficacy and toxicity of induction chemotherapy in acute myeloid leukemia.
Megías-Vericat JE; (...); Montesinos P
Article. 10.1080/10428194.2020.1839650. 2020
IMPACT OF PULMONARY ARTERIAL HYPERTENSION WITH OR WITHOUT INTERSTITIAL LUNG DISEASE ON SCLERODERMA: A RETROSPECTIVE COHORT STUDY FROM THE NATIONWIDE SPANISH SCLERODERMA (RESCLE) AND PULMONARY ARTERIAL HYPERTENSION (REHAP) REGISTRIES
Guillen-del-Castillo, A.; (...); Simeon-Aznar, C. P.
Meeting Abstract. 10.1136/annrheumdis-2020-eular.4302. 2020
Impact of the alveolar-arterial oxygen gradient on prognosis after liver transplantation in adults: a single-center experience
Ortega, AG; (...); Reyes, RL
Meeting Abstract. 10.1183/13993003.congress-2020.1917. 2020
Impact of the therapeutic positioning report in the P&R process in Spain: analysis of orphan drugs approved by the European Commission and reimbursed in Spain from 2003 to 2019
Badia X; (...); Hernández C
Article. 10.1186/s13023-020-01507-4. 2020
Implementation and results of a risk-sharing scheme for enzyme replacement therapy in lysosomal storage diseases
Edo-Solsona, MD, Vitoria-Minana, I, Poveda-Andres, JL
Article. 10.7399/fh.11262. 2020
Incidence, risk factors, and thrombotic load of pulmonary embolism in patients hospitalized for COVID-19 infection.
García-Ortega A; (...); Martínez-García MÁ
Article. 10.1016/j.jinf.2021.01.003. 2021
Influence of polymorphisms in anthracyclines metabolism genes in the standard induction chemotherapy of acute myeloid leukemia.
Megías-Vericat JE; (...); Montesinos P
Article. 10.1097/FPC.0000000000000431. 2021
Inter-observer correlation in detection of pulmonary hypertension (PH) after an acute pulmonary embolism (PE)
Chasco Eguilaz, Leyre; (...); Sanchez Diaz, Jose Maria
Meeting Abstract. 10.1183/13993003.congress-2019.PA1446. 2019
Intravitreal melphalan therapy for vitreous seeds in retinoblastoma: Implementation and outcomes of a new chemotherapy protocol.
Solana-Altabella A; (...); Poveda JL
Article. 10.1177/1078155220904410. 2020
Involvement of interleukin 6 in SARS-CoV-2 infection: siltuximab as a therapeutic option against COVID-19
Palanques-Pastor, T, Lopez-Briz, E, Andres, JLP
Article. 10.1136/ejhpharm-2020-002322. 2020
Late Breaking Abstract - Incidence, risk factors and thrombotic load of pulmonary embolism in patients hospitalized with COVID-19
Bekki, Amina; (...); Angel Martinez-Garcia, Miguel
Meeting Abstract. 10.1183/13993003.congress-2021.OA2597. 2021
Management of flexible cavovarus foot in patients with Charcot-Marie-Tooth disease: midterm results.
Megías-Vericat JE; (...); Poveda-Andrés JL
Article. 2021
Matching-Adjusted Indirect Comparison of Efficacy and Consumption of rVIII-SingleChain Versus Two Recombinant FVIII Products Used for Prophylactic Treatment of Adults/Adolescents with Severe Haemophilia A
Bonanad, S; (...); Santos, S
Article. 10.1007/s12325-021-01853-0. 2021
Metabolic Phenotyping in Prostate Cancer Using Multi-Omics Approaches.
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
Article. 10.3390/cancers14030596. 2022
Metyrapone as treatment in the neonatal McCune-Albright syndrome
de Mingo, Carmen; (...); Garcia-Robles, Ana
Article. 10.1515/jpem-2020-0036. 2020
Monitoring coagulation factors during surgery. A systematic review
Eduardo Megias-Vericat, Juan; (...); Luis Poveda-Andres, Jose
Review. 10.7399/fh.11766. 2021
Monitoring contamination of hazardous drug compounding surfaces at hospital pharmacy departments. A consensus Statement. Practice guidelines of the Spanish Society of Hospital Pharmacists (SEFH).
Valero-García S; (...); Delgado-Sánchez O
Article. 10.7399/fh.11655. 2021
Multi-Omic Approaches to Breast Cancer Metabolic Phenotyping: Applications in Diagnosis, Prognosis, and the Development of Novel Treatments
Gomez-Cebrian, N; (...); Pineda-Lucena, A
Review. 10.3390/cancers13184544. 2021
National Survey of the SEFH-2019: portfolio of services, healthcare activity, teaching and research in Hospital Pharmacy Services in Spain (vol 45, pg 32, 2021)
Perez-Encinas, Montserrat; (...); Angel Calleja-Hernandez, Miguel
Correction. 10.7399/fh.11740. 2021
Outcome of patients with acute symptomatic pulmonary embolism and psychiatric disorders
Velasco, D; (...); RIETE Investigators
Article. 10.1016/j.thromres.2020.05.052. 2020
Outcome of patients with acute symptomatic pulmonary embolism and psychiatric disorders
Velasco Alvarez, Diurbis Josefina; (...); Jimenez Castro, David
Meeting Abstract. 10.1183/13993003.congress-2020.4973. 2020
Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol
Garcia-Robles, Ana; (...); Carrascosa, MA
Article. 10.3389/fped.2020.00372. 2020
Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol (vol 8, 372, 2020)
Garcia-Robles, Ana; (...); Aguar Carrascosa, Marta
Correction. 10.3389/fped.2021.834454. 2022
Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project
Morillo-Verdugo, R; (...); Diaz-Olmo, J
Article. 10.7399/fh.11719. 2021
Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project.
Morillo-Verdugo R; (...); Díaz-Olmo J
Article. 2021
Pharmaceutical care to hospital outpatients during the COVID-19 pandemic. Telepharmacy
Margusino-Framiñán L; (...); Morillo-Verdugo R
Article. 10.7399/fh.11498. 2020
Pharmacometabolomics by NMR in Oncology: A Systematic Review.
Gómez-Cebrián N; (...); Pineda-Lucena A
Article. 10.3390/ph14101015. 2021
Pharmacotherapeutic management of advanced therapy medicinal products
Luis Poveda-Andres, Jose; (...); Valero-Garcia, Silvia
Article. 10.7399/fh.13036. 2022
PK-GUIDED SWITCH BETWEEN STANDARD HALF-LIFE AND EXTENDED HALF-LIFE FACTOR VIII PRODUCTS
Vericat, JEM; (...); Iorio, A
Meeting Abstract. 2020
Portopulmonary hypertension: prognosis and management in the current treatment era. Results from the REHAP Registry.
Lázaro Salvador M; (...); Escribano Subías P
Article. 10.1111/imj.14751. 2020
Preparación y administración de perfusiones de insulina en neonatología: Encuesta nacional.
García-Robles A; (...); Aguar-Carrascosa M
Letter. 10.1016/j.anpedi.2020.06.008. 2021
Preparation and administration of insulin infusions in neonatology: A national survey.
Garcia-Robles, Ana; (...); Aguar Carrascosa, Marta
Article. 10.1016/j.anpede.2020.06.015. 2021
Presenting Characteristics, Treatment Patterns, and Outcomes among Patients with Venous Thromboembolism during Hospitalization for COVID-19.
Fernández-Capitán C; (...); Monreal M
Article. 10.1055/s-0040-1718402. 2020
Pretriscuspid shunt and Eisenmenger syndrome: a deadly combination
Escribano, JP; (...); Subias, PE
Meeting Abstract. 2020
Prevalence of obstructive sleep apnea in acute phase of pulmonary embolism: Preliminary results of ESAET study
Yepez, GJO; (...); Garcia, MAM
Meeting Abstract. 10.1183/13993003.congress-2020.2505. 2020
Proactive therapeutic drug monitoring and pharmacogenetic analysis in inflammatory bowel disease: A systematic review
Ballesta-Lopez, Octavio; (...); Luis Poveda-Andres, Jose
Review. 10.7399/fh.11780. 2021
Randomised controlled trial of a prognostic assessment and management pathway to reduce the length of hospital stay in normotensive patients with acute pulmonary embolism.
Jimenez, David; (...); IPEP investigators
Article. 10.1183/13993003.00412-2021. 2021
Relationship between comorbidities and quality of life perceived by patients diagnosed with pulmonary hypertension: Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH)
Martinez Menaca, Amaya; (...); Lopez Reyes, Raquel
Meeting Abstract. 10.1183/13993003.congress-2019.PA1442. 2019
Rivaroxaban or apixaban in fragile patients with acute venous thromboembolism
Trujillo-Santosa, J; (...); RIETE Investigators
Article. 10.1016/j.thromres.2020.06.035. 2020
SEFH National Survey-2019: general characteristics, staffing, material resources and information systems in Spain's hospital pharmacy departments.
Pérez-Encinas M; (...); Calleja-Hernández MÁ
Article. 10.7399/fh.11565. 2020
SMPTall man lettering application in medication information systems as a quality and safety strategy in hospital organization
Iglesias Gomez, Ruben; (...); Poveda Andres, Jose Luis
Article. 10.1111/jcpt.13703. 2022
Systematic Review of Pharmacogenetics of ABC and SLC Transporter Genes in Acute Myeloid Leukemia
Megías-Vericat JE; (...); Montesinos P
Review. 10.3390/pharmaceutics14040878. 2022
The contribution of fenfluramine to the treatment of Dravet syndrome in Spain through Multi-Criteria Decision Analysis.
Gil-Nagel A; (...); Gil A
Article. 10.1016/j.yebeh.2022.108711. 2022
Thrombotic Risk and Covid-19: Review of Current Evidence for a Better Diagnostic and Therapeutic Approach.
López-Reyes R; (...); García-Ortega A
Review. 10.1016/j.arbres.2020.07.033. 2021
Towards a symbiotic relationship between big data, artificial intelligence, and hospital pharmacy
Del Rio-Bermudez, C; (...); Poveda, JL
Editorial Material. 10.1186/s40545-020-00276-6. 2020
Undetectable levels of adalimumab in clinical practice: Should we say goodbye to the drug?
Bejar, S; (...); Mateu, PN
Meeting Abstract. 2020
USE OF CAPLACIZUMAB IN THE ACQUIRED THROMBOTIC THROMBOCYTOPENIC PURPURA
Dominguez Hernandez, L.; (...); Gomez Segui, I
Meeting Abstract. 2019
Venous thromboembolism in solid-organ transplant recipients: findings from the RIETE registry
Ortega, AG; (...); Monreal, M
Meeting Abstract. 10.1183/13993003.congress-2020.3571. 2020
Venous thromboembolism in solid-organ transplant recipients: Findings from the RIETE registry.
Garcia-Ortega, Alberto; (...); RIETE Investigators
Article. 10.1016/j.thromres.2021.02.022. 2021