Study of Dutogliptin in Combination With Filgrastim in Post-Myocardial Infarction

NCT03486080 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: REC-DUT-002
• Study Type: interventional
• Target: 49
• Locations: 5 countries
• Sites: 12

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

Conditions

Acute Myocardial Infarction; Acute Myocardial Ischemia; STEMI - ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Safety assessment of the number of Grade 3 and 4 treatment emergent AEs or serious AEs (SAEs) as assessed by CTCAE v4.0.AEs (SAEs) as assessed by CTCAE v4.0.

  Assess the tolerability of a combination of dutogliptin and filgrastim

  90 days

Secondary Outcomes (8)

• Cardiovascular efficacy LVEF

  90 days

• Cardiovascular efficacy LVESV

  90 days

• Cardiovascular efficacy LVEDV

  90 days

• Cardiovascular tissue damage reduction

  90 days

• Cardiovascular LFM

  90 days

Study Arms (2)

Dutogliptin/filgrastim combination

ACTIVE COMPARATOR

Twice daily SC injections of 60 mg dutogliptin tartrate for 14 days in combination with 10 µg/kg filgrastim injectable product for 5 days

Drug: Dutogliptin Tartrate; Drug: Filgrastim Injectable Product

Placebo control

PLACEBO COMPARATOR

Twice daily dutogliptin SC placebos for 14 days in combination with matching filgrastim SC placebos for 5 days

Drug: Placebos

Interventions

Dutogliptin Tartrate DRUG

Active treatment

Also known as: dutogliptin

Dutogliptin/filgrastim combination

Filgrastim Injectable Product DRUG

Active treatment

Also known as: filgrastim

Dutogliptin/filgrastim combination

Placebos DRUG

placebo control

Also known as: placebo

Placebo control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Recardio, Inc.: lead

Study Sites (12)

Clinical department of Cardiology

Graz, Austria

Location

Klinikum Klagenfurt am Wörthersee

Klagenfurt, 9020, Austria

Location

Algemeen Stedelijk Ziekenhuis Aalst

Aalst, Belgium

Location

Military Hospital

Budapest, Hungary

Location

Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika

Budapest, Hungary

Location

Debreceni Egyetem Kardiológiai és Szívsebészeti Klinika

Debrecen, Hungary

Location

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

Miskolc, Hungary

Location

Maasstad Ziekenhuis

Rotterdam, Netherlands

Location

Nicolaus Copernicus University

Bydgoszcz, Poland

Location

SPS Szpital Zachodni

Grodzisk Mazowiecki, 05-825, Poland

Location

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi ul. Pomorska 251

Lodz, 92-213, Poland

Location

Samodzielny Publiczny Szpital Wojewódzki im. Papieża Jana Pawła II

Zamość, Poland

Location

Related Links

• Recardio, Inc. Homepage

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

dutogliptin; Filgrastim

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Roman Schenk, MD

  Recardio, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: April 3, 2018
• Study Start: December 7, 2018
• Primary Completion: February 26, 2021
• Study Completion: February 26, 2021
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); AU (2); NL (1); PL (4); HU (4)