EUCTR2018-000916-75-PL进行中（未招募）1 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction - REC-DUT-002
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female born between 1933 and 2000
- •2. Body weight <96 kg (~212 lb).
- •3.Able to provide written informed consent, including signing and dating the informed consent form (ICF).
- •4.Diagnosis of STEMI (defined as new ST-segment elevation at the J point of at least 2 continuous leads of >2 mm [0.2 mV] in men or >1.5 mm [0.1 mV] in women in leads V2 and V3 OR >1 mm in any other contiguous precordial leads or the limb leads [for both men and women]) with PCI (bare metal or drug-eluting stent) and Thrombolysis in Myocardial Infarction flow grade 2 or 3 occurring >2 hours and <24 hours after symptom onset.
- •5.Left ventricular ejection fraction (LVEF) =45% obtained by cECHO performed within 36 hours post-stent placement.
- •6.Receiving standard medical therapy for post-myocardial infarction (MI) treatment, according to local procedures and PI discretion.
- •7.Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and an additional negative urine pregnancy test prior to the first dose of IMP unless regulated differently by national legislation.
- •8.Sexually active female subjects of childbearing potential (i.e., women who are not postmenopausal or who have not had a bilateral oophorectomy, hysterectomy, or tubal ligation) and all male subjects (who have not been surgically sterilized by vasectomy) must agree to use effective contraception during the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.Previous MI prior to Screening.
- •2.Complex peri/post-MI clinical course, including arrhythmias, cardiogenic shock, pulmonary edema requiring mechanical ventilation, or requirement for vasopressor medications.
- •3.Significant pre-existing cardiomyopathy with known LVEF =45% or moderate to severe mitral or aortic valvular disease.
- •4.Amyloidosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis.
- •5.Existing heart transplant.
- •6.Ventricular tachycardia or fibrillation not associated with an acute ischemic episode.
- •7.Uncontrolled hypertension (systolic >180 mmHg or diastolic >120 mmHg).
- •8.Treatment with any DPP4 inhibitors (e.g., alogliptin, linagliptin, vildagliptin, saxagliptin, sitagliptin) or granulocyte-colony stimulating factor medication (e.g., filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim) within 4 months prior to Randomization.
- •9.Contraindication to treatment with filgrastim, including known allergy to filgrastim or other G-CSF medication.
- •10.Anemia defined as hemoglobin <9 g/dL prior to Randomization.
- •11.Thrombocytosis (platelets >500 k/uL).
- •12.Known positive serology for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
- •13.Alanine aminotransferase (ALT) concentrations >3 times the upper limit of normal (ULN) or bilirubin >2 x ULN prior to Randomization, according to local laboratory assessments.
- •14.History of cirrhosis and Child-Pugh score B or C.
- •15.Current fever greater than 101.4F (38.6C) or recent systemic infection within 2 weeks prior to Randomization.
- •16.Contraindication to cMRI procedure, including prior implantable cardioverter defibrillator placement, known reaction to gadolinium, claustrophobia, non-MRI-compatible, cochlear implant, obesity, or presence of ferromagnetic material including shunts, shrapnel, penile prostheses, or blood vessel coil.
- •17.Pregnant, planning to become pregnant, or nursing female subjects.
- •18.Autoimmune disease requiring immunosuppressive therapy or chronic steroid treatment >5 mg/day prednisolone or equivalent.
- •19.Significant renal impairment defined as estimated glomerular filtration rate <45 mL/min/1.73 m2, using the Chronic Kidney Disease Epidemiology Collaboration equation.
- •20.Active neoplasm requiring surgery, chemotherapy, or radiation within the prior 12 months (subjects with a history of malignancy who have undergone curative resection or otherwise not requiring treatment for at least 12 months prior to Screening with no detectable recurrence are allowed).
- •21.Malignant hematological disease, i.e., chronic myeloid leukemia or myelodysplastic syndrome.
- •22.History of cerebrovascular accident or transient ischemic attack in the past 6 months.
- •23.History of pneumonia in the last 4 weeks.
- •24.History of any significant medical or psychiatric disorder that in the opinion of the investigator would make the subject unsuitable for participation in the study.
- •25.Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) or treatment with an investigational biologic drug within 6 weeks prior to Randomization.
- •26.Participation in another concurrent clinical trial involving a therapeutic intervention (participation in observational studies and/or registry studies is permitted).
- •27.Unable or unwilling to comply with the requirements of the study.
- •28. Subject and/or an immediate family member is an employee of the investigational sit
研究者
相似试验
进行中（未招募）
1 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Safety and Efficacy of AV608 in Subjects with Idiopathic Detrusor OveractivityIdiopathic Detrusor Overactivity (Overactive Bladder)EUCTR2005-005868-93-GBAVERA PHARMACEUTICALS INC.62
进行中（未招募）
1 期
A study to assess the safety and effectiveness of enzalutamide in patients with advanced hepatocellular carcinomaMale and female subjects with HCC of any etiology who have progressed on or were intolerant to sorafenib or other anti-VEGF therapy in the advanced settingMedDRA version: 18.1Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-004283-37-ESAstellas Pharma Global Development, Inc.165
进行中（未招募）
1 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Safety and Efficacy of AV608 in Subjects with Idiopathic Detrusor OveractivityIdiaopathic Detrusor Overactivity (Overactive Bladder)EUCTR2005-005868-93-NLAVERA PHARMACEUTICALS INC.62
进行中（未招募）
1 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of BIO89-100 in Subjects with Severe HypertriglyceridemiaSevere Hypertriglyceridemia (SHTG)MedDRA version: 20.1Level: LLTClassification code 10020870Term: HypertriglyceridemiaSystem Organ Class: 100000004861EUCTR2020-000641-13-HU89bio, Inc.90
进行中（未招募）
1 期
A study to test the efficacy and safety of the drug INCB054707 on a skin condition called Prurigo NodularisPrurigo NodularisMedDRA version: 20.0Level: LLTClassification code 10037084Term: Prurigo nodularisSystem Organ Class: 100000004858EUCTR2021-006329-23-ESIncyte Corporation140