Efficacy, Safety and Tolerability of ATH3G10 in Patients... | NCT03991143

Studies
Efficacy, Safety and Tolerability of ATH3G10 in Patients With ST-elevation Myocardial Infarction

NCT03991143

Sponsor

Athera Biotechnologies AB

Status

Completed

Last Update Posted

May 3, 2021Actual

Enrollment

82Actual

Phase

Phase 2

Conditions

ST Elevation Myocardial Infarction

Interventions

ATH3G10
Placebo

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2018-003676-12	EudraCT Number

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 29, 2019Actual

Primary Completion Date

Jul 6, 2020Actual

Completion Date

Apr 19, 2021Actual

First Submitted Date

Jun 14, 2019

First Submission Date that Met QC Criteria

Jun 18, 2019

First Posted Date

Jun 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2021

Last Update Posted Date

May 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients with ST-segment elevation myocardial infarction (STEMI) that have suffered a major anterior wall infarction or where coronary blood flow is less than normal in spite of successful percutaneous coronary intervention (PCI) have a poor prognosis. There are today no medical treatments that specifically reduce risk in these patients. The acute inflammatory reaction in conjunction with a STEMI and reperfusion by PCI determines the final size of the infarction and the signals leading to left ventricular remodelling.

This study is designed to assess the efficacy and safety of single intravenous injection with ATH3G10, a fully human IgG1 antibody against phosphorylcholine, in high-risk subjects with STEMI. ATH3G10 aims to reduce inflammation and thereby infarction size and remodeling.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ATH3G10	Experimental	Phosphorylcholine human monoclonal antibody (ATH3G10)	Drug: ATH3G10
Placebo	Placebo Comparator	Placebo to ATH3G10, 0.9% sodium chloride	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ATH3G10	Drug	intravenous	ATH3G10	PC-mAB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Left ventricular remodelling	Change in Left Ventricular End-Diastolic Volume index (LV EDVi)	From Visit2 (day 3) to visit 3 (day 90)

Secondary Outcomes

Measure	Description	Time Frame
Myocardial Salvage index (MSi)	Effects on myocardial salvage index (MSi) measured by MRI	Visit 2 (day 3)

Other Outcomes

Measure	Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]	Assessment of Safety and Tolerability based on incidence of AEs/SAEs	From baseline (Visit 1, day 1) to visit 3 (day 90)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute myocardial infarction with ST elevation at the J-point in two contiguous leads
Start of PCI less than 4 hours after symptom onset.

Exclusion Criteria:

Cardiogenic chock, non-compensated acute heart failure and/or pulmonary edema.
Previous major vascular intervention within the last 4 weeks.
History of an infarct in the same artery that is currently affected.
Conditions contraindicating MRI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology, Uppsala University Hospital		Uppsala		75237	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000072657	ST Elevation Myocardial Infarction

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided