Portal de investigación
- Inicio
- Proyectos y Estudios
- UN ESTUDIO DE PRUEBA DE CONCEPTO DE FASE 2A, DOBLE CIEGO, DE GRUPO PARALELO ALEATORIZADO Y CONTROLADO CON PLACEBO QUE EVALÚA LA EFICACIA, LA SEGURIDAD Y LA FARMACOCINÉTICA DE OBE022 COMBINADO CON ATOSIBAN TRAS SU ADMINISTRACIÓN POR VÍA ORAL A MUJERES EMBARAZADAS CON AMENAZA DE PARTO PREMATURO.
UN ESTUDIO DE PRUEBA DE CONCEPTO DE FASE 2A, DOBLE CIEGO, DE GRUPO PARALELO ALEATORIZADO Y CONTROLADO CON PLACEBO QUE EVALÚA LA EFICACIA, LA SEGURIDAD Y LA FARMACOCINÉTICA DE OBE022 COMBINADO CON ATOSIBAN TRAS SU ADMINISTRACIÓN POR VÍA ORAL A MUJERES EMBARAZADAS CON AMENAZA DE PARTO PREMATURO.
Datos básicos
- Protocolo:
- 17-OBE022-003
- EUDRACT:
- 2017-002579-25
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Año de incio:
- 2018
- Año de finalización:
- 2020
Documentos
- No hay documentos
Participantes
Financiadores - Promotores
Resultados del Ensayo Clínico
A Comparative Study of Vaginal Labor and Caesarean Section Postpartum Uterine Myoelectrical Activity
Diaz-Martinez, A; (...); Ye-Lin, YY
Article. 10.3390/s20113023. 2020
A more accurate prediction to rule in and rule out pre-eclampsia using the sFlt-1/PlGF ratio and NT-proBNP as biomarkers.
Lafuente-Ganuza P; (...); Alvarez FV
Article. 10.1515/cclm-2019-0939. 2020
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
Acute Promyelocytic Leukemia during Pregnancy: A Systematic Review of the Literature
Santolaria, A; (...); Sanz, MA
Review. 10.3390/cancers12040968. 2020
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
Alterations of carbohydrate metabolism during pregnancy. Effects on the mother and new born infant.
Guerrero Cervera B; (...); Llopis-Gonzalez A
Article. 10.1016/j.medcli.2019.04.021. 2020
Analysing criteria for price and reimbursement of orphan drugs in Spain.
Badia, X; (...); Tort, M
Article. 10.7399/fh.11147. 2019
Bayesian pharmacokinetic-guided prophylaxis with recombinant factor VIII in severe or moderate haemophilia A
Megias-Vericat, JE; (...); Poveda, JL
Article. 10.1016/j.thromres.2018.12.027. 2019
Birth-weight differences at term are explained by placental dysfunction and not by maternal ethnicity. Study in newborns of first generation immigrants.
Morales-Roselló J; (...); Marín AP
Article. 10.1080/14767058.2020.1755651. 2020
Cell-Free DNA Methylation Profiles in Preeclampsia Highlight Multi-Organ Involvement Identifying Potential Targets for Future Sequelae.
Corachan, I; (...); Simon, C
Meeting Abstract. 2019
Cerebroplacental ratio and estimated fetal weight, the 2 different yardsticks
Morales-Rosello, J; (...); Perales-Marin, A
Letter. 10.1016/j.ajog.2019.08.038. 2019
Clinical pharmacy services: from cost-effectiveness analysis to a productivity indicators model
Nogueras, A; (...); Calleja, MA
Letter. 10.1136/ejhpharm-2019-001905. 2019
Combined Cell-Free DNA Methylation and Fragment Size Profiles in Pre-eclampsia Identify Multi-Organ Involvement for Future Sequelae.
Corachan, I; (...); Diez-Juan, A
Meeting Abstract. 2020
Comparison of Cerebroplacental Ratio, Intergrowth-21st Standards, Customized Growth, and Local Population References for the Prediction of Fetal Compromise: Which Is the Best Approach?
Morales-Rosello, J; (...); Marin, AP
Article. 10.1159/000497142. 2019
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
Congenital knee dislocation, case report and review of the literature.
Morales-Roselló J; (...); Perales-Marín A
Review. 10.1080/14767058.2020.1731464. 2020
COST MINIMIZATION ANALYSIS OF RITUXIMAB BIOSIMILAR VERSUS REFERENCE RITUXIMAB IN THE TREATMENT OF FOLLICULAR LYMPHOMA
Gironella, M.; (...); Oyaguez, I
Meeting Abstract. 2019
Cost-effectiveness of Cladribine Tablets and fingolimod in the treatment of relapsing multiple sclerosis with high disease activity in Spain.
Poveda JL; (...); Torres C
Article. 10.1080/14737167.2019.1635014. 2020
Cross-sectional comparative study of pharmacokinetics and efficacy between sucrose-formulated recombinant factor VIII (Kogenate (R)) and BAY 81-8973 (KovaltryA (R)) in patients with severe or moderate haemophilia A in prophylaxis
Megias-Vericat, JE; (...); Poveda, JL
Letter. 10.1111/hae.13733. 2019
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
Characterization of the effects of Atosiban on uterine electromyograms recorded in women with threatened preterm labor
Mas-Cabo, J; (...); Garcia-Casado, J
Article. 10.1016/j.bspc.2019.04.001. 2019
Daunorubicin and cytarabine for certain types of poor-prognosis acute myeloid leukemia: a systematic literature review
Megias-Vericat, JE; (...); Montesinos, P
Review. 10.1080/17512433.2019.1573668. 2019
Design and Assessment of a Robust and Generalizable ANN-Based Classifier for the Prediction of Premature Birth by means of Multichannel Electrohysterographic Records
Mas-Cabo, J; (...); Ye-Lin, Y
Article. 10.1155/2019/5373810. 2019
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 and validation of an MCDA framework for evaluation and decision-making of orphan drugs in Spain
Badia, X; (...); Poved, JL
Article. 10.1080/21678707.2019.1652163. 2019
Does Uterine Doppler Add Information to the Cerebroplacental Ratio for the Prediction of Adverse Perinatal Outcome at the End of Pregnancy?
Morales-Roselló J; (...); Perales Marín A
Article. 10.1159/000499483. 2019
Electrohysterogram for ANN-Based Prediction of Imminent Labor in Women with Threatened Preterm Labor Undergoing Tocolytic Therapy
Mas-Cabo, J; (...); Ye-Lin, Y
Article. 10.3390/s20092681. 2020
Endometrial Transcriptomic Fingerprinting Associated to In Vivo Decidualization Resistance in Severe Preeclampsia.
Garrido-Gomez, T; (...); Simon, C
Meeting Abstract. 2020
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
Fecal Calprotectin Pretreatment and Induction Infliximab Levels for Prediction of Primary Nonresponse to Infliximab Therapy in Crohn's Disease
Beltran, B; (...); Nos, P
Article. 10.1159/000492626. 2019
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
Impact of voriconazole plasma concentrations on treatment response in critically ill patients
Ruiz, J; (...); Ramirez, P
Article. 10.1111/jcpt.12817. 2019
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
Influence of concomitant immunomodulators during maintenance therapy with Adalimumab in inflammatory bowel disease: looking for the ideal patient to use monotherapy
Bastida, G; (...); Nos, P
Meeting Abstract. 10.1093/ecco-jcc/jjy222.581. 2019
Intraperitoneal vancomycin in neonates during peritoneal dialysis: A case report
Company-Albir, MJ; (...); Poveda, JL
Article. 10.1111/jcpt.12842. 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
Is it possible to predict late antepartum stillbirth by means of cerebroplacental ratio and maternal characteristics?
Morales-Roselló J; (...); Perales-Marín A
Article. 10.1080/14767058.2019.1566900. 2020
Maternal profile according to Mediterranean diet adherence and small for gestational age and preterm newborn outcomes.
Peraita-Costa I; (...); Morales-Suárez-Varela M
Article. 10.1017/S1368980019004993. 2020
Maternal telomere length is shorter in intrauterine growth restriction versus uncomplicated pregnancies, but not in the offspring or in IVF-conceived newborns.
Perales-Puchalt A; (...); Blasco MA
Article. 10.1016/j.rbmo.2018.12.008. 2019
Mathematical simulation of Doppler changes in late-onset smallness; progression patterns of cerebral and umbilical anomalies define two types of late-onset fetal growth restriction.
Morales-Rosello, Jose; (...); Perales-Marin, Alfredo
Article. 10.1080/14767058.2019.1671346. 2021
Metabolic disorders and inflammation are associated with familial combined hyperlipemia
Diaz-Ruiz, M; (...); Hernandez-Mijares, A
Article. 10.1016/j.cca.2018.09.009. 2019
Metyrapone as treatment in the neonatal McCune-Albright syndrome
de Mingo, Carmen; (...); Garcia-Robles, Ana
Article. 10.1515/jpem-2020-0036. 2020
MicroRNA-148b-3p and MicroRNA-25-3p Are Overexpressed in Fetuses with Late-Onset Fetal Growth Restriction
Morales-Rosello, J; (...); Marin, AP
Article. 10.1159/000507619. 2020
Monozygotic twins discordant for trisomy 4: a case report and a literature review.
Hoyas PC; (...); Perales Marín A
Review. 10.1080/01443615.2019.1650013. 2020
New electrohysterogram-based estimators of intrauterine pressure signal, tonus and contraction peak for non-invasive labor monitoring
Benalcazar-Parra, C; (...); Prats-Boluda, G
Article. 10.1088/1361-6579/ab37db. 2019
Non-invasive Intrauterine Pressure Estimation Based on Nonlinear Parameters Computed from the Electrohysterogram
Albaladejo-Belmonte, M; (...); Garcia-Casado, J
Proceedings Paper. 10.1007/978-3-030-31635-8_14. 2020
Ovarian stimulation with corifollitropin alfa followed by hp-hMG compared to hp-hMG in patients at risk of poor ovarian response undergoing ICSI: A randomized controlled trial
Taronger, R; (...); Pellicer, A
Article. 10.1016/j.ejogrb.2018.10.034. 2018
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
Pharmaceutical care to hospital outpatients during the COVID-19 pandemic. Telepharmacy
Margusino-Framiñán L; (...); Morillo-Verdugo R
Article. 10.7399/fh.11498. 2020
PK-GUIDED SWITCH BETWEEN STANDARD HALF-LIFE AND EXTENDED HALF-LIFE FACTOR VIII PRODUCTS
Vericat, JEM; (...); Iorio, A
Meeting Abstract. 2020
Postpartum hemorrhage with pelvic arterial embolization, study of 33 cases
Aguilar-Crespo A; (...); Perales-Marín A
Article. 10.1080/14767058.2017.1387527. 2019
Prediction of Labor Induction Success from the Uterine Electrohysterogram
Benalcazar-Parra, C; (...); Prats-Boluda, G
Article. 10.1155/2019/6916251. 2019
Pregnancy Control in Patients with Systemic Lupus Erythematosus and Antiphospholipid Syndrome. Part 1: Infertility, Ovarian Preservation and Preconception Assessment. Consensus Document of the Spanish Society of Gynaecology and Obstetrics (SEGO), the Spanish Society of Internal Medicine (SEMI) and the Spanish Society of Rheumatology (SER).
Espinosa G; (...); Martínez-Taboada VM
Article. 10.1016/j.reuma.2019.09.002. 2019
PRELIMINAR STUDY OF THERAPY ADHERENCE CONTROLLED BY PRESCRIPTION OF MEDICATION AND SELF-PERCEPTION ADHERENCE OF INFLAMMATORY CHRONIC DISEASE PATIENTS
Garcia, EG; (...); Ivorra, JAR
Meeting Abstract. 10.1136/annrheumdis-2019-eular.5937. 2019
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
Protocol for the study and treatment of primary immune thrombocytopenia: ITP-2018
Monteagudo, E; (...); Spanish Soc Paediat Haematol
Article. 10.1016/j.anpede.2019.04.008. 2019
Protocolo de estudio y tratamiento de la trombocitopenia inmune primaria: PTI-2018.
Monteagudo E; (...); Dapena JL
Abstract of Published Item. 10.1016/j.anpedi.2019.04.014. 2019
Re: Cerebroplacental ratio in predicting adverse perinatal outcome: a meta-analysis of individual participant data.
Morales-Roselló J; (...); Perales-Marín A
Letter. 10.1111/1471-0528.16376. 2020
Registro español de cribado de Covid-19 en gestantes asintomáticas.
Encinas Pardilla MB; (...); Martínez Pérez Ó
Article. 2020
Robust Characterization of the Uterine Myoelectrical Activity in Different Obstetric Scenarios
Mas-Cabo, J; (...); Prats-Boluda, G
Article. 10.3390/e22070743. 2020
Sirenomelia, case report and review of the literature.
Morales-Rosello, Jose; (...); Perales-Marin, Alfredo
Review. 10.1080/14767058.2020.1742693. 2020
Spanish registry of Covid-19 screening in asymptomatic pregnants
Pardilla, MBE; (...); Perez, OM
Article. 2020
Topiramate pharmacokinetics in neonates undergoing therapeutic hypothermia and proposal of an optimised dosing schedule.
Marques MR; (...); Mangas-Sanjuan V
Article. 10.1111/apa.14944. 2020
Trajectories of stress biomarkers and anxious-depressive symptoms from pregnancy to postpartum period in women with a trauma history
Ghosn, F; (...); Blanco, AG
Article. 10.1080/20008198.2019.1601990. 2019
Undetectable levels of adalimumab in clinical practice: Should we say goodbye to the drug?
Bejar, S; (...); Mateu, PN
Meeting Abstract. 2020
Use and handling safety of Mini-Spike 2 (R) chemo and puresite for safe chemotherapy compounding in a hospital pharmacy
Garcia, SV; (...); Andres, JLP
Article. 10.1016/j.yrtph.2018.10.002. 2018
USE OF CAPLACIZUMAB IN THE ACQUIRED THROMBOTIC THROMBOCYTOPENIC PURPURA
Dominguez Hernandez, L.; (...); Gomez Segui, I
Meeting Abstract. 2019
Uterine electromyography for discrimination of labor imminence in women with threatened preterm labor under tocolytic treatment
Mas-Cabo, J; (...); Ye-Lin, YY
Article. 10.1007/s11517-018-1888-y. 2019
What is the impact of mother's bed incline on episodes of decreased oxygen saturation in healthy newborns in skin-to-skin contact after delivery: Study protocol for a randomized controlled trial
Lopez, JR; (...); Alonso, CRP
Article. 10.1186/s13063-019-3256-0. 2019