EUCTR2018-000916-75-HU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, age 18 to 85 (having reached 18 and before having reached 86 at the time of ICF signing)
- •2. Body weight <96 kg (212 lb).
- •3. Able to provide written informed consent, including signing and dating the (ICF).
- •4. Diagnosis of STEMI (defined as new ST-segment elevation at the J point of at least two 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 up to 24 hours after symptom onset (to time of first balloon inflation).
- •5. Left ventricular ejection fraction (LVEF) =45% obtained by cECHO performed within 36 hours post-stent placement.
- •6. Receiving standard medical therapy for post-MI treatment, according to local procedures and the Principal Investigator’s 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 highly effective contraception during treatment and for 4 weeks after the last dose.
- •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 G-CSF 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/µL).
- •12. Known positive serology for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), any other indication of liver disease or injury
- •13. ALT concentrations >3 times the upper limit of normal (ULN) and bilirubin (TBL) >2 x ULN, or INR >1.5 prior to Randomization, according to local laboratory assessments, and/or any indication of liver disease or injury. If ALT is between >3 and 8 x ULN, and all other admission criteria are met, the test may be repeated within the time window before Randomization.
- •14. History of cirrhosis and Child-Pugh score B or C
- •15. Current fever greater than 101.4 °F (38.6 °C) 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, morbid 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 past 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 any 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 five 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 stud
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