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Hemoglobin-based Oxygen Carrier

PP-007 for Ischemic Stroke (HEMERA-1 Trial)

Phase 1

Recruiting

Research Sponsored by Prolong Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years of age

If the patient were to receive MT, patient must have a history of last seen well ≤ 24 hours prior to start of MT

Must not have

Contraindication to radiographic imaging procedures including known hypersensitivity to radiographic contrast agents, known renal insufficiency precluding repeated contrast administration

Blood glucose <50 mg/dL (2.78 mmol) or >400 mg/dL (22.20 mmol) that is not responsive to appropriate treatment at Baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety of PP-007, a modified cow protein given through an IV, in stroke patients. It aims to improve blood flow and reduce brain damage. The study includes patients already receiving standard stroke treatments.

Who is the study for?

This trial is for adults who've had a recent stroke caused by a blockage in the brain's large arteries. They should have specific imaging findings, be within 24 hours of symptom onset, and have been relatively healthy before the stroke. Participants must also agree to use effective contraception.

What is being tested?

The study tests PP-007, a new drug given through IV alongside standard clot-busting treatments or mechanical clot removal. Patients will get two doses of PP-007 about one day apart to see if it improves blood flow and recovery after stroke.

What are the potential side effects?

Possible side effects are not detailed here but may include reactions related to IV infusion and effects from altering blood components since PP-007 contains modified hemoglobin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I was last seen in good health less than 24 hours before my mechanical thrombectomy.

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I was last seen well less than 4.5 hours before starting IVT treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot undergo certain imaging tests due to allergies or kidney problems.

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My blood sugar is not between 50 and 400 mg/dL despite treatment.

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I have a history or current signs of kidney or liver disease.

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I have a brain tumor, blood vessel malformation, or aneurysm.

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I had a seizure when my stroke started, making it hard to assess my condition accurately.

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I do not have severe heart problems or very high blood pressure.

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I have had strokes in multiple areas of my brain.

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I had a severe head injury within the last 3 months and still have problems from it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

12-lead ECG

AESI, Blood pressure

AESI, Liver panel

+13 more

Secondary study objectives

Clinical Activity

Clinical Activity, ASITN collateral score

Clinical Activity, NIHSS and mRS

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PP-007 along with Standard of care (SOC)Experimental Treatment1 Intervention

The study has only single arm, wherein, patients will receive two doses of PP-007 (24 ± 6 hours apart), along with the Standard-of-care (SOC) as per the site's medical practice. SOC is defined as Intravenous thrombolysis (IVT) or Mechanical Thrombectomy (MT) or both (IVT+MT).

0 / 11Eligibility criteria met