NCT04225533

Brief Summary

This study will evaluate the potential benefit of blocking inflammation during a heart attack using an investigational anti-inflammatory medicine called SP16. The study will enroll 10 patients and all 10 patients will receive a standard dose of SP16.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 24, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 30, 2023

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

January 8, 2020

Results QC Date

December 8, 2022

Last Update Submit

January 4, 2023

Conditions

Myocardial InfarctionInflammation

Outcome Measures

Primary Outcomes (1)

  • Area Under the Curve (AUC) for C-reactive Protein (CRP)

    This study will evaluate the anti-inflammatory effect of SP16 by calculating the AUC for CRP. This is done by measuring CRP at baseline, 72 hours, and 14 days. The AUC will then be compared to historical controls to evaluate whether or not SP16 reduces the AUC for CRP.

    Baseline, 72 hours, 14 days

Secondary Outcomes (3)

  • Area Under Curve (AUC) for Creatine-Kinase Myocardial Band (CK-MB)

    72 hours

  • Change in Left Ventricular Ejection Fraction (LVEF) at Baseline and 365 Days

    365 days

  • Diagnosis of Heart Failure

    365 days

Study Arms (1)

SP16

EXPERIMENTAL

Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection

Drug: SP16

Interventions

SP16DRUG

All patients will receive a single dose of SP16

SP16

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Inability to give informed consent
  • Hemodynamic instability as defined as need for inotropic or vasoactive agents, or need for mechanical support devices (including intra-aortic balloon pump)
  • Pregnancy or breastfeeding
  • Preexisting congestive heart failure (American Heart Association/American College of Cardiology class C-D, New York Heart Association III-IV)
  • Preexisting severe left ventricular dysfunction (LVEF\<20%)
  • Preexisting severe valvular heart disease
  • Known active infections (acute or chronic)
  • Recent (\<14 days) or active use of immunosuppressive drugs (including but not limited to high-dose corticosteroids \[\>1 mg/kg of prednisone equivalent\], tumor necrosis factor-alpha blockers, cyclosporine) not including non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids used for intravenous (IV) dye allergy only)
  • Recent (\<14 days) or active use of anti-inflammatory drugs (not including NSAIDs or corticosteroids used for IV dye allergy only)
  • Known chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)
  • Known active malignancy of any type, or prior diagnosis in the past 10 years
  • Neutropenia (absolute neutrophil count\<1,800/mm3 \[or \<1,000/mm3 in African American patients\])
  • Severe impairment in renal function (estimated glomerular filtration rate \<30 ml/kg\*min)
  • Anticipated need for cardiac or major surgery
  • Known Allergy to SP16

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • Van Tassell BW, Wohlford GF, Del Buono MG, Damonte JI, Markley R, Turlington J, Kadariya D, Talasaz A, Ho J, Marawan A, Thomas GK, Austin D, Gineste C, Gelber C, Abbate A. Safety, Tolerability, and Effects of a Single Subcutaneous Administration of SP16 - a SERPIN-like, Small Peptide Agonist of the Low-Density Lipoprotein-like Receptor 1- on the Acute Inflammatory Response in Patients With ST-Segment Elevation Myocardial Infarction. J Cardiovasc Pharmacol. 2022 Nov 1;80(5):672-678. doi: 10.1097/FJC.0000000000001331.

    PMID: 35881895DERIVED

MeSH Terms

Conditions

Myocardial InfarctionInflammation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Results Point of Contact

Title
Dr. Cohava Gelber
Organization
Serpin Pharma, LLC
cgelber@serpinpharma.com
7033433258

Study Officials

  • Antonio Abbate, MD, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 13, 2020

Study Start

February 24, 2020

Primary Completion

January 4, 2021

Study Completion

December 21, 2021

Last Updated

January 30, 2023

Results First Posted

January 30, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)