Portal de investigación
Ensayo de fase III, multicéntrico, aleatorizado, con doble enmascaramiento y comparativo con placebo para evaluar la eficacia y la seguridad del efgartigimod (ARGX-113) PH20 subcutáneo en pacientes adultos con trombocitopenia inmunitaria primaria.
Datos básicos
- Protocolo:
- ARGX-113-2004
- EUDRACT:
- 2020-004032-21
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Año de incio:
- 2022
- Año de finalización:
Objetivos del proyecto
Objetivo Principal: Evaluar la eficacia del efgartigimod PH20SC y compararla con la del placebo PH20 SCen la obtención de una respuesta prolongadaen la cifra de plaquetas en pacientes con TIPcrónica. La respuesta prolongada en la cifrade plaquetas se define como una cifra deplaquetas =50 × 10 9/l durante un mínimo de 4 de las 6 visitas realizadas entre las semanas19 y 24 del ensayo. Objetivos Secundarios: • Evaluar la eficacia del efgartigimod PH20 s.c. en comparación con la del placebo PH20 s.c. en la respuesta plaquetaria global • Evaluar la incidencia y la intensidad de los episodios de hemorragia durante el tratamiento con efgartigimod PH20 s.c. en comparación con las del placebo PH20 s.c. • Evaluar la seguridad y la tolerabilidad del efgartigimod PH20 s.c. administrado semanalmente o cada dos semanas (c2s) en comparación con placebo PH20 s.c. • Evaluar el uso de tratamiento de rescate y en el tratamiento simultáneo para la TPI durante el periodo de administración del tratamiento con efgartigimod PH20 s.c. en comparación con los del placebo PH20 s.c. • Evaluar los efectos de efgartigimod PH20 s.c. en las mediciones de la calidad de vida (CdV) y los resultados percibidos por el paciente (RPP) en comparación con los del placebo PH20 s.c. • Evaluar la inmunogenia del efgartigimod y la rHuPH20 • Evaluar los efectos farmacodinámicos (FD) del efgartigimod PH20 s.c.
Documentos
- No hay documentos
Participantes
Financiadores - Promotores
Resultados del Ensayo Clínico
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 multi-criteria decision analysis on the value of nintedanib for interstitial lung diseases.
Zozaya, Neboa; (...); Verde, Luis
Article. 10.1017/S0266462322000459. 2022
A simple score to predict early severe infections in patients with newly diagnosed multiple myeloma
Encinas, Cristina; (...); Martinez-Lopez, Joaquin
Article. 10.1038/s41408-022-00652-2. 2022
Autologous stem cell transplantation as consolidation of first-line chemotherapy in patients with peripheral T-cell lymphoma: a multicenter GELTAMO/FIL study.
García-Sancho AM; (...); Caballero D
Article. 10.3324/haematol.2021.279426. 2022
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
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano JB; (...); Soto-Ortega I
Article. 10.1016/j.farma.2023.01.003. 2023
Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.
Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada
Article. 10.1016/j.farma.2023.04.002. 2023
Cytokine response as a biomarker for early diagnosis and outcome prediction of stem cell transplant recipients and acute leukemia patients with invasive aspergillosis.
Puerta-Alcalde, Pedro; (...); Garcia-Vidal, Carolina
Article. 10.1093/mmy/myac038. 2022
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
Design and Validation of a Custom Next-Generation Sequencing Panel in Pediatric Acute Lymphoblastic Leukemia.
Gil, Jose Vicente; (...); Barragan, Eva
Article. 10.3390/ijms24054440. 2023
Eltrombopag Added to Immunosuppression in Severe Aplastic Anemia.
Peffault de Latour R; (...); Risitano AM
Article. 10.1056/NEJMoa2109965. 2022
Geriatric assessment in hematology scale predicts treatment tolerability in older patients diagnosed with hematological malignancies: The RETROGAH study.
de la Rubia J; (...); Bonanad, Santiago
Article. 10.1016/j.jgo.2022.10.016. 2022
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
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
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
Immunoparesis Recovery in Transplant-Ineligible Newly Diagnosis Multiple Myeloma Patients: An Independent Prognosis Factor That Could Complement Prognostic Value of Minimal Residual Disease
Lakhwani, Sunil; (...); Hernandez, Miguel-Teodoro
Meeting Abstract. 10.1182/blood-2022-166826. 2022
Impact of pre- and/or post-autologous stem cell transplantation exposure to brentuximab vedotin on survival outcomes in patients with high-risk Hodgkin lymphoma.
Martinez, Carmen; (...); Garcia-Sanz, Ramon
Article. 10.1007/s00277-022-05011-6. 2022
Ixazomib Plus Lenalidomide/Dexamethasone (IRd) Versus Lenalidomide /Dexamethasone (Rd) Maintenance after Autologous Stem Cell Transplant in Patients with Newly Diagnosed Multiple Myeloma: Results of the Spanish GEM2014MAIN Trial
Rosinol, Laura; (...); Blade Creixenti, Joan
Meeting Abstract. 10.1182/blood-2021-146798. 2021
Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.
Vázquez Polo A; (...); Vázquez Costa JF
Article. 10.20960/nh.03946. 2022
Metabolic Phenotyping in Prostate Cancer Using Multi-Omics Approaches.
Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor
Article. 10.3390/cancers14030596. 2022
National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies
Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis
Meeting Abstract. 10.1182/blood-2022-169938. 2022
Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus
Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis
Article. 10.1097/MD.0000000000032208. 2022
Odronextamab in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL): Results from a Prespecified Analysis of the Pivotal Phase II Study ELM-2
Kim, Won-Seog; (...); Walewski, Jan
Meeting Abstract. 10.1182/blood-2022-158406. 2022
ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.
Poveda JL; (...); Badia X
Article. 10.1186/s13023-022-02610-4. 2023
Panel Sequencing for Clinically Oriented Variant Screening and Copy Number Detection in Chronic Lymphocytic Leukemia Patients
Ibanez, Mariam; (...); Luna I
Article. 10.3390/diagnostics12040953. 2022
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
Pharmacotherapeutic management of advanced therapy medicinal products
Luis Poveda-Andres, Jose; (...); Valero-Garcia, Silvia
Article. 10.7399/fh.13036. 2022
Prognostic Value of Serum Paraprotein Response Kinetics in Patients With Newly Diagnosed Multiple Myeloma.
Tamariz-Amador, Luis-Esteban; (...); Troconiz, Inaki F.
Article. 10.1016/j.clml.2022.04.024. 2022
Recovery of Uninvolved Heavy/Light Chain Pair Immunoparesis during Maintenance Is an Independent Prognostic Factor for Multiple Myeloma and Could Complement Prognosis Value of Minimal Residual Disease
Lakhwani, Sunil; (...); Hernandez, Miguel-Teodoro
Meeting Abstract. 10.1182/blood-2022-167247. 2022
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 association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity
Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar
Article. 10.1007/s00431-022-04628-z. 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