COMPLETED

Safety Study of PP-007 in Subjects With Acute Ischemic Stroke

Conditions

Acute Ischemic Stroke Stroke Thrombectomy Intravenous Thrombolysis NIHSS, mRS, ASPECTS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The HEMERA-1 Extension (Part III) is a prospective, open-label, multicenter study to evaluate safety of two doses of PP-007 in Acute Ischemic Stroke (AIS) subjects receiving Intravenous Thrombolysis (IVT) or mechanical thrombectomy (MT) or IVT+MT as standard of care (SOC). Subjects will receive two doses of PP-007 infusion 24 ± 6 hours apart in addition to the site-specific SOC protocol. PP-007 is PEGylated bovine carboxyhemoglobin and will be administered via IV infusion. The effects on collateral flow, infarct size and functional outcomes will be evaluated.

Official Title

A Randomized, Phase 1, Contemporaneously Controlled, Multicenter Study to Assess the Safety of PP-007 in Subjects With Acute Ischemic Stroke (HEMERA-1)

Quick Facts

Study Start:2024-04-24

Study Completion:2025-02-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04677777

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject or subject's LAR has provided informed consent. 2. ≥18 years of age. 3. If the patient were to receive MT, patient must have a history of last seen well ≤ 24 hours prior to start of MT 4. If the patient were to receive IVT, patient must have a history of last seen well ≤ 4.5 hours prior to start of IVT or as per Institution SOC Note: Onset is defined as the time point when symptoms first began, or if unknown, the last time point when the subject reported or was observed having normal (baseline) neurological function. 5. AIS patient with ASPECTS ≥ 3 to 10 6. AIS patient with life expectancy of 90 days, as determined by the investigator 7. Patient with disabling stroke defined as baseline NIHSS ≥ 6 prior to IP administration 8. mRS ≤ 2 (pre-morbid), prior to onset of symptoms (self-reported or family/caregiver reported) 9. At the time of stroke, patient must be living in their own home, apartment or seniors lodge where no nursing care/support is required 10. Subject and caregiver are available for protocol-required follow-up visits 11. Contraception and pregnancy: 1. Male subjects, and females of childbearing potential (subjects and female partners of male subjects who are ovulating, premenopausal, and not surgically sterile) must use a highly effective method of contraception consistently and correctly during study participation and up to 90 days following PP-007 infusion. 2. Highly effective methods of contraception are those that, either alone or in combination, result in a failure rate of \<1% per year when used consistently and correctly, including:	1. ASPECTS \< 3 on NCCT 2. Multi-arterial territorial strokes (e.g. bilateral, anterior and posterior circulation) 3. Evidence of symptomatic intracranial hemorrhage, including subarachnoid hemorrhage, on initial CTA/CTP, or history of intracranial hemorrhage within the last 30 days. 4. Pre-existing neurological or psychiatric disease that would confound neurological or functional evaluations in the opinion of the Investigator. 5. A seizure at stroke onset that precludes obtaining an accurate screening NIHSS and mRS assessment 6. Clinical history, past imaging, or clinical judgment suggests that the intracranial occlusion is chronic 7. History of severe head injury within 90 days of Baseline with residual neurological deficit at the time of AIS. 8. Clinically significant heart disease including: 9. Refractory BP (systolic \>200 and/or diastolic \>120 mmHg). 10. Confirmed diagnosis of septic embolus or bacterial endocarditis within the past six months. 11. Aortic dissection. 12. Contraindication to radiographic imaging procedures including: 13. Prior treatment (within the last 30 days) or planned concurrent treatment with an investigational medication or device. 14. Blood glucose \<50 mg/dL (2.78 mmol) or \>400 mg/dL (22.20 mmol) that is not responsive to appropriate treatment at Baseline. 15. Known bleeding disorder (e.g., coagulopathy or thrombocytopenia). 16. Known history or current evidence of renal or hepatic disease including: 1. Documented renal insufficiency (serum creatinine \>3.0 × ULN). 2. History of liver disease (i.e., alanine transaminase \[ALT\] and/or Aspartate transaminase (AST) \>2 × ULN and/or conjugated bilirubin \>1.5 mg/dL). 1. Significant mass effect with midline shift ≥8 mm. 2. Evidence of intracranial mass (except for small non-clinically significant meningioma based on the Investigator's discretion). 1. AIS patient with ASPECTS ≥ 3 to 10 1. Multi-arterial territorial strokes (e.g. bilateral, anterior and posterior circulation) 2. Evidence of symptomatic intracranial hemorrhage, including subarachnoid hemorrhage, on NCCT or CTA/CTP. 3. Clinically significant heart disease including: 1. Documented renal insufficiency (serum creatinine \>3.0 × ULN). 2. Documented liver disease (i.e., alanine transaminase \[ALT\] and/or Aspartate transaminase (AST) \>2 × ULN and/or conjugated bilirubin \>1.5 mg/dL). 1. Parenchymal hematoma (PH-1 and PH-2) 2. Symptomatic intracranial hemorrhage 3. Hemicraniectomy 4. Midline shift ≥ 8 mm 5. Mass effect 6. Significant cerebral edema Note: LVO and/or SVO will be allowed as long as the respective study subject meets the inclusion and exclusion criteria defined above. The decision to administer the 2nd dose will be based on subject's safety and PI's discretion.

Inclusion Criteria

Exclusion Criteria

1. Subject or subject's LAR has provided informed consent.
2. ≥18 years of age.
3. If the patient were to receive MT, patient must have a history of last seen well ≤ 24 hours prior to start of MT
4. If the patient were to receive IVT, patient must have a history of last seen well ≤ 4.5 hours prior to start of IVT or as per Institution SOC Note: Onset is defined as the time point when symptoms first began, or if unknown, the last time point when the subject reported or was observed having normal (baseline) neurological function.
5. AIS patient with ASPECTS ≥ 3 to 10
6. AIS patient with life expectancy of 90 days, as determined by the investigator
7. Patient with disabling stroke defined as baseline NIHSS ≥ 6 prior to IP administration
8. mRS ≤ 2 (pre-morbid), prior to onset of symptoms (self-reported or family/caregiver reported)
9. At the time of stroke, patient must be living in their own home, apartment or seniors lodge where no nursing care/support is required
10. Subject and caregiver are available for protocol-required follow-up visits
11. Contraception and pregnancy:
1. Male subjects, and females of childbearing potential (subjects and female partners of male subjects who are ovulating, premenopausal, and not surgically sterile) must use a highly effective method of contraception consistently and correctly during study participation and up to 90 days following PP-007 infusion.
2. Highly effective methods of contraception are those that, either alone or in combination, result in a failure rate of \<1% per year when used consistently and correctly, including:

1. ASPECTS \< 3 on NCCT
2. Multi-arterial territorial strokes (e.g. bilateral, anterior and posterior circulation)
3. Evidence of symptomatic intracranial hemorrhage, including subarachnoid hemorrhage, on initial CTA/CTP, or history of intracranial hemorrhage within the last 30 days.
4. Pre-existing neurological or psychiatric disease that would confound neurological or functional evaluations in the opinion of the Investigator.
5. A seizure at stroke onset that precludes obtaining an accurate screening NIHSS and mRS assessment
6. Clinical history, past imaging, or clinical judgment suggests that the intracranial occlusion is chronic
7. History of severe head injury within 90 days of Baseline with residual neurological deficit at the time of AIS.
8. Clinically significant heart disease including:
9. Refractory BP (systolic \>200 and/or diastolic \>120 mmHg).
10. Confirmed diagnosis of septic embolus or bacterial endocarditis within the past six months.
11. Aortic dissection.
12. Contraindication to radiographic imaging procedures including:
13. Prior treatment (within the last 30 days) or planned concurrent treatment with an investigational medication or device.
14. Blood glucose \<50 mg/dL (2.78 mmol) or \>400 mg/dL (22.20 mmol) that is not responsive to appropriate treatment at Baseline.
15. Known bleeding disorder (e.g., coagulopathy or thrombocytopenia).
16. Known history or current evidence of renal or hepatic disease including:
1. Documented renal insufficiency (serum creatinine \>3.0 × ULN).
2. History of liver disease (i.e., alanine transaminase \[ALT\] and/or Aspartate transaminase (AST) \>2 × ULN and/or conjugated bilirubin \>1.5 mg/dL).
1. Significant mass effect with midline shift ≥8 mm.
2. Evidence of intracranial mass (except for small non-clinically significant meningioma based on the Investigator's discretion).
1. AIS patient with ASPECTS ≥ 3 to 10
1. Multi-arterial territorial strokes (e.g. bilateral, anterior and posterior circulation)
2. Evidence of symptomatic intracranial hemorrhage, including subarachnoid hemorrhage, on NCCT or CTA/CTP.
3. Clinically significant heart disease including:
1. Documented renal insufficiency (serum creatinine \>3.0 × ULN).
2. Documented liver disease (i.e., alanine transaminase \[ALT\] and/or Aspartate transaminase (AST) \>2 × ULN and/or conjugated bilirubin \>1.5 mg/dL).
1. Parenchymal hematoma (PH-1 and PH-2)
2. Symptomatic intracranial hemorrhage
3. Hemicraniectomy
4. Midline shift ≥ 8 mm
5. Mass effect
6. Significant cerebral edema Note: LVO and/or SVO will be allowed as long as the respective study subject meets the inclusion and exclusion criteria defined above. The decision to administer the 2nd dose will be based on subject's safety and PI's discretion.

Contacts and Locations

Principal Investigator

Kirsten Gruis, MD

STUDY_DIRECTOR

Prolong Pharmaceuticals, LLC

Study Locations (Sites)

Baptist Health Research Institute

Jacksonville, Florida, 32207

United States

Baptist Health Miami Cardiac & Vascular Institute (MCVI)

Miami, Florida, 33176

United States

Emory University School of Medicine

Atlanta, Georgia, 30303

United States

Saint Luke's Hospital

Kansas City, Missouri, 64111

United States

Mercy Health - St. Vincent Medical Center

Toledo, Ohio, 43608

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Oregon Stroke Center at Oregon Health & Science University (OHSU)

Portland, Oregon, 97239

United States

UPMC Stroke Institute

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Prolong Pharmaceuticals

Kirsten Gruis, MD, STUDY_DIRECTOR, Prolong Pharmaceuticals, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-24

Study Completion Date2025-02-20

Study Record Updates

Study Start Date2024-04-24

Study Completion Date2025-02-20

Terms related to this study

Keywords Provided by Researchers

Stroke
Thrombectomy
Intravenous Thrombolysis
NIHSS, mRS, ASPECTS

Additional Relevant MeSH Terms

Acute Ischemic Stroke