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Hemoglobin-based Oxygen Carrier
PP-007 for Stroke (HEMERA-1 Trial)
Phase 1
Waitlist Available
Research Sponsored by Prolong Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
HEMERA-1 Trial Summary
This trial will study the safety of giving patients with Acute Ischemic Stroke a single IV infusion of PP-007, a pegylated form of bovine carboxyhemoglobin. The study will also look at the effects of PP-007 on collateral flow, infarct size, and functional outcome. Patients will be randomized to either standard of care (excluding tPA) or to receive PP-007. Patients may also receive thrombectomy.
Eligible Conditions
- Stroke
HEMERA-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
12-lead ECG
AESI, Blood pressure
AESI, Liver panel
+13 moreSecondary outcome measures
Clinical Activity
Clinical Activity, ASITN collateral score
Clinical Activity, NIHSS and mRS
+3 moreHEMERA-1 Trial Design
2Treatment groups
Experimental Treatment
Group I: Standard of CareExperimental Treatment1 Intervention
Patients randomized to receive this treatment will receive standard of care appropriate for the condition.
Group II: PP-007Experimental Treatment1 Intervention
Patients randomized to receive this treatment will receive a single infusion of PP-007
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PP-007
2021
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Prolong PharmaceuticalsLead Sponsor
14 Previous Clinical Trials
289 Total Patients Enrolled
Prayag Shah, MD, MBAStudy DirectorProlong Pharmaceuticals, LLC
Prayag N Shah, MD, MBAStudy DirectorProlong Pharmaceuticals, LLC
Frequently Asked Questions
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