Título: Estudio de fase 3 multicéntrico, aleatorizado, abierto y ciego de evaluación de criterios de valoración que compara el efecto de abelacimab en relación con apixaban sobre la recurrencia y el sangrado del tromboembolismo venoso (TEV) en pacientes con TEV asociado al cáncer (ASTER)
Especialidad: Oncología
Código de protocolo: ANT-007
Número EudraCT: 2023-509569-19
Promotor: Anthos Therapeutics
Investigador principal: Dr. Jesús Rodríguez Pascual
Más información:
CRO: IQVIA
Criterios de inclusión: Male or female subjects 18 years old or another legal maturity age according to the country of residence
Confirmed diagnosis of cancer (by histology or adequate imaging modality), other than basal-cell or squamous-cell carcinoma of the skin alone with one of the following: Active cancer, defined as either locally active, regionally invasive, or metastatic cancer at the time of randomization, and/or oCurrently receiving or having received anticancer therapy (radiotherapy, chemotherapy, hormonal therapy, any kind of targeted therapy or any other anticancer therapy) in the last 6 months.
Confirmed symptomatic or incidental proximal lower limb DVT (i.e., popliteal, femoral, iliac, and/or inferior vena cava vein thrombosis) and/or a confirmed symptomatic or incidental PE of a segmental, or larger pulmonary artery, and/or a confirmed symptomatic or incidental PE of two or more subsegmental pulmonary arteries. Patients are eligible within 120 hours from diagnosis of the qualifying VTE.
Anticoagulation therapy with a therapeutic dose of DOAC for at least 6 months is indicated.
Able to provide written informed consent.
Criterios de exclusión: Thrombectomy, insertion of a caval filter or use of a fibrinolytic agent to treat the current (index) occurrence of DVT and/or PE More than 120 hours of pre-treatment with therapeutic doses of UFH, LMWH, fondaparinux, DOAC, or other anticoagulants
Bleeding requiring medical attention at the time of randomization or in the preceding 4 weeks
Planned brain, spinal cord, cardiac, vascular, major thoracic and/or major abdominal surgery in the 4 weeks following randomization.
Eastern Cooperative Oncology Group (ECOG) performance status of 3 or 4 at screening
Life expectancy <3 months at randomization
Calculated creatinine clearance (CrCl) <30 mL/min (Cockcroft-Gault equation) at the screening visit
Hemoglobin less than 8 g/dL at the screening visit
Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range at the screening visit in absence of clinical explanation
Uncontrolled hypertension (systolic BP>180 mm Hg or diastolic BP >100 mm Hg despite antihypertensive treatment)
Women of child-bearing potential (WOCBP) who are unwilling or unable to use highly effective contraceptive measures during the study from screening up to 3 days after last treatment of dalteparin or 100 days after administration of abelacimab (See Section 5.3.6 for highly effective contraceptive measures).
Sexually active males with sexual partners of childbearing potential must agree to use a condom or other reliable contraceptive measure up to 3 days after last treatment of dalteparin or 100 days after administration of abelacimab
An indication to continue treatment with therapeutic doses of an anticoagulant other than that used for VTE treatment prior to randomization (e.g., atrial fibrillation, mechanical heart valve, prior VTE)
Pregnant or breast-feeding women
Patients known to be receiving strong dual inducers or inhibitors of both CYP3A4 and P-gp
History of hypersensitivity to any of the study drugs (including apixaban) or its excipients, to drugs of similar chemical classes, or any contraindication listed in the label for apixaban
Subjects with any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study
Use of other investigational (not-registered) drugs within 5 half-lives prior to enrollment or until the expected pharmacodynamic effect has returned to baseline, whichever is longer. Participation in academic noninterventional or interventional studies, comprising testing different strategies or different combinations of registered drugs is permitted.
Platelet count <50,000/mm3 at the screening visit
PE leading to hemodynamic instability (systolic blood pressure [BP] <90 mmHg or shock)
Acute ischemic or hemorrhagic stroke or intracranial hemorrhage within 4 weeks preceding screening
Brain trauma, or a cerebral or a spinal cord surgery or spinal procedures such as lumbar puncture or epidural/spinal anesthesia in the 4 weeks preceding screening
Need for aspirin in a dosage of more than 100 mg/per day or any other antiplatelet agent alone or in combination with aspirin
Primary brain cancer or untreated intracranial metastases at baseline
Acute myeloid or lymphoid leukemia at baseline.
Centro: Vithas Madrid La Milagrosa
Título: Estudio doble ciego, randomizado, control activo, grupos paralelos, fase3, para comparar la eficacia y seguridad de CT-P51 y Keytruda en combinación con Pemetrexem-Platino quimioterapia en pacientes con metástasis previa no tratada de células no pequeñas no escamosas de pulmón
Especialidad: Oncología
Código de protocolo: CT-P51 3-1
Número EudraCT: 2024-514048-98-00
Promotor: CELLTRION
Investigador principal: Dr. Lisardo Ugidos
Más información:
CRO: Syneos Health
Centro: Vithas Madrid La Milagrosa
Título: Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo y multicéntrico para investigar la eficacia, la seguridad y la tolerabilidad de LP352 en el tratamiento de las crisis convulsivas en niños y adultos con encefalopatías epilépticas y del desarrollo
Especialidad: Neurología
Código de protocolo: LP352-301
Número EudraCT: 2024-516412-17-00
Promotor: LongBoard Pharmaceutical
Investigador principal: Dr. Ángel Aledo
Más información:
CRO: PPD
Centro: Vithas Madrid La Milagrosa
Título: Estudio abierto, multicéntrico y a largo plazo para evaluar la seguridad, la tolerabilidad y la eficacia de XEN1101 en pacientes adultos con diagnóstico de epilepsia
Especialidad: Neurología
Código de protocolo: XPF-010-304
Número EudraCT: 2022-502282-24-00
Promotor: Xenon Pharmaceuticals Inc.
Investigador principal: Dr. Ángel Aledo
Más información:
CRO: Worldwide
Criterios de inclusión: Subject must have successfully completed the Double bling period (DBP) and have not terminated early from Study X-TOLE2, X-TOLE3, or X-ACKT, met all eligibility requirements, and had no important protocol deviations (in the opinion of the sponsor) or AEs (in the opinion of the investigator) that would preclude the subjects entry into the long-term extension study.
Subject is able to keep accurate seizure diaries.
Subject must be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study.
Subject must be willing to comply with the contraception requirements as defined in protocol Section 5.3.
Male subjects must agree not to donate sperm until 3 months after the last dose of study drug. Female subjects must agree not to donate ova until 6 months after the last dose of study drug.
In the opinion of the investigator, the subject is able to understand verbal and written instructions and will adhere to all study schedules and requirements.
Criterios de exclusión: Subject met any of the withdrawal criteria while in Study X-TOLE2, X-TOLE3, or X-ACKT
Subject has any medical condition, personal circumstance, or ongoing AE (from Study X-TOLE2, X-TOLE3, or X-ACKT) that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study, or prevents adherence to the protocol.
Female subject who is pregnant, breastfeeding, or planning to become pregnant prior to 6 months after the last dose of study drug.
Subject is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of epilepsy or any other medical condition during the study and until 28 days after completion of this study.
Centro: Vithas Madrid La Milagrosa
Título: Un estudio de fase 2 multicéntrico, aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis, grupo paralelo, de un anticuerpo anti-TSLP (GSK5784283) en adultos de 18 a 75 años de edad con asma no controlada
Especialidad: Neumología
Código de protocolo: 223125
Número EudraCT: 2024-518321-15
Promotor: GSK
Más información:
CRO: IQVIA
Criterios de inclusión: Informed Consent: Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol. The participant must be willing and able to comply with trial and follow-up procedures
Acceptable inhaler, and spirometry techniques during the run-in period.
Age: Participants must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
Documented physician-diagnosed asthma for 2 years that meets the National Heart, Lung, and Blood Institute guidelines or GINA Main Report 2024 Global Strategy for Asthma Management and Prevention
Evidence of variable airflow obstruction consistent with asthma as documented by: a) Positive bronchodilator response (reversibility) during screening at either Visit 2a or Visit 2b using the Maximum Post-Bronchodilator Procedure as evidenced by an increase in FEV1 of 12% and 200 mL from the pre-bronchodilator value or b) A documented positive post-bronchodilator response (reversibility) according to the FEV1 criteria in a (above) within 24 months of Visit 1 or c) Documented Airway hyperresponsiveness (methacholine: PC20 of <8 mg/mL, mannitol: decrease in FEV1 15%) documented in the 24 months prior to Visit 3 (randomization visit)
Documented history of asthma exacerbations within 12 months prior to Visit 1: An asthma exacerbation is defined as a worsening of asthma symptoms that led to either of the following: the use of systemic glucocorticoids for 3 or more days (a single depo-injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids) or an emergency room (ER) visit (defined as evaluation and treatment for <24 hours in an ER or urgent care center) that required systemic corticosteroids (as per above) OR an inpatient hospitalization (24 hours) due to asthma
A well- documented requirement for regular treatment with medium or high-dose ICS for at least 6 months prior to screening. a. High-dose ICS is defined as a total daily dose (sum of all inhaled glucocorticoid) of >500g fluticasone propionate DPI or MDI, or equivalent. b. Medium Dose ICS is defined as a total daily dose (sum of all inhaled glucocorticoid) of 250 to 500g fluticasone propionate DPI or MDI or equivalent.
At least one additional maintenance asthma controller medication is required according to standard practice of care (e.g., LABA, LTRA, theophylline, LAMA, chromones, etc.). Use of additional asthma controller medications must be documented for at least 3 months prior to Visit 1.
Weight 40 kg
Male or eligible female: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WONCBP) OR Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, 28 days prior to the 1st dose of the study drug and during the study intervention period and follow-up period after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g. non-compliance, recently initiated) in relationship to the first dose of study intervention. A WOCBP must have a negative serum pregnancy test at screening and a highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before each dose of study intervention. o If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with location regulations regarding the methods of highly effective contraception for those participating in clinical trials.
Criterios de exclusión: Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (e.g., current upper or lower respiratory tract infection, chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, Churg- Strauss syndrome, primary ciliary dyskinesia).
Subjects randomized in the current study or previous studies.
Receipt of any marketed or investigational biologic agent within 4 months or 5 halflives prior to Visit 1, whichever is longer and up until the end of study.
Receipt of any investigational non-biologic agent within 30 days or 5 half-lives prior to screening, whichever is longer and up until the end of study.
Experimental vaccines are not permitted within 30 days prior to randomization and up until the end of the study.
Use of immunosuppressive medication (e.g., methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, systemic (oral) corticosteroids, ) within 3 months prior to Visit 1 and up until the end of study. NB: systemic (oral, IV or IM) corticosteroids will be permitted for the treatment of asthma exacerbations.
Systemic corticosteroid burst including taper within 15 days prior to Visit 1 or during the screening/run-in period.
Subjects who have not responded to Tezepelumab treatment.
Receipt of live or live attenuated vaccine(s) within 30 days prior to randomization or plans to receive such vaccines up until the end of study.
Helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy.
Active or latent tuberculosis: Participants with a diagnosis or evidence of active or latent tuberculosis are excluded from the study. Note: If clinically indicated, additional testing for tuberculosis should be performed by the investigator during the screening/run-in period and ahead of the randomization visit. The choice to perform a QuantiFERON Gold Plus test or T-SPOT will be made by the investigator according to local licensing and standard of care. The QuantiFERON Gold Plus test can only be used in countries where it is licensed, and the use of this test is dependent on previous treatment(s). This test may not be suitable if previous treatment(s) produced significant immunosuppression.
Diagnosis of vocal cord dysfunction, dysfunctional breathing, or pseudo steroid resistant asthma.
Malignancy: A current malignancy or previous history of cancer in remission for less than 5 years prior to screening (Participants that had localized carcinoma of the skin which was resected for cure will not be excluded).
History of an unresolved clinically significant infection within 30 days prior to Visit 1.
A known immunodeficiency (e.g. human immunodeficiency virus HIV), other than that explained by the use of corticosteroids taken as therapy for asthma.
Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, rheumatologic, metabolic, neurological, renal, gastrointestinal, hepatic, hematological or any other system abnormalities that are uncontrolled with standard treatment including eosinophilic conditions such as hyper-eosinophilic syndrome (HES) and eosinophilic granulomatosis with polyangiitis (EGPA).
Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs at Visit 2 which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subjects ability to participate in the study.
Centro: Vithas Xanit Internacional