Status:
COMPLETED
Study of Dutogliptin in Combination With Filgrastim in Post-Myocardial Infarction
Lead Sponsor:
Recardio, Inc.
Conditions:
Acute Myocardial Infarction
Acute Myocardial Ischemia
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction
Detailed Description
Dutogliptin 60 mg administered by twice daily subcutaneous (SC) injection for 14 days in combination with a fixed standard dose of filgrastim (10 µg/kg) administered SC daily for 5 days. This study wi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 1\. Male or female born between 1933 and 2000.
- Body weight \<96 kg (212 lb).
- Able to provide written informed consent, including signing and dating the informed consent form (ICF).
- 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.
- LVEF ≤45% obtained by cECHO performed within 36 hours post-stent placement.
- Receiving standard medical therapy for post-MI treatment, according to local procedures and Principal Investigator discretion
- 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.
- 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.
- Exclusion criteria
- Previous MI prior to Screening.
- Complex peri/post-MI clinical course, including arrhythmias, cardiogenic shock, pulmonary edema requiring mechanical ventilation, or requirement for vasopressor medications.
- Significant pre-existing cardiomyopathy with known LVEF ≤45% or moderate to severe mitral or aortic valvular disease.
- Amyloidosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis.
- Existing heart transplant.
- Ventricular tachycardia or fibrillation not associated with an acute ischemic episode.
- Uncontrolled hypertension (systolic \>180 mmHg or diastolic \>120 mmHg).
- 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.
- Contraindication to treatment with filgrastim, including known allergy to filgrastim or other G-CSF medication.
- Anemia defined as hemoglobin \<9 g/dL prior to Randomization.
- Thrombocytosis (platelets \>500 k/µL).
- Known positive serology for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
- 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.
- History of cirrhosis and Child-Pugh score B or C.
- Current fever greater than 101.4 °F (38.6 °C) or recent systemic infection within 2 weeks prior to Randomization.
- 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.
- Pregnant, planning to become pregnant, or nursing female subjects.
- Autoimmune disease requiring immunosuppressive therapy or chronic steroid treatment \>5 mg/day prednisolone or equivalent.
- Significant renal impairment defined as estimated glomerular filtration rate \<45 mL/min/1.73 m2, using the Chronic Kidney Disease Epidemiology Collaboration equation.
- 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).
- Malignant hematological disease, i.e., chronic myeloid leukemia or myelodysplastic syndrome.
- History of cerebrovascular accident or transient ischemic attack in the past 6 months.
- History of pneumonia in the last 4 weeks.
- 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.
- 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.
- Participation in another concurrent clinical trial involving a therapeutic intervention (participation in observational studies and/or registry studies is permitted).
- Unable or unwilling to comply with the requirements of the study.
- Subject and/or an immediate family member is an employee of the investigational site directly affiliated with this study, the sponsor or the contract research organization.
- Considered by the investigator to be unsuitable to participate in the study for any other reason.
- Persons who are in an institution as a result of an administrative or judicial order, or soldiers.
- History of alcohol or drug abuse.
Exclusion
Key Trial Info
Start Date :
December 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2021
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03486080
Start Date
December 7 2018
End Date
February 26 2021
Last Update
May 27 2021
Active Locations (12)
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1
Clinical department of Cardiology
Graz, Austria
2
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria, 9020
3
Algemeen Stedelijk Ziekenhuis Aalst
Aalst, Belgium
4
Military Hospital
Budapest, Hungary