1. Inicio
  2. Proyectos y Estudios
  3. 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

Código:
17-OBE022-003
Protocolo:
17-OBE022-003
EUDRACT:
2017-002579-25
NCT:
Centro:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Dotación:
Año de incio:
2018
Año de finalización:
2020
ENSAYO CLÍNICO INTERNACIONAL

Documentos

  • No hay documentos

Participantes

Grupos

Financiadores - Promotores

OBSEVA S.A.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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


Campos de estudio

Compartir