NCT00479895

Brief Summary

The test compound and subject of this clinical trial is the haemoglobin-based oxygen carrier, HBOC-201 (Hemopure). HBOC-201, initially developed as an alternative to red blood cells for surgical patients, has the ability to restore tissue oxygenation in persistently ischemic tissue. The development of this new class of compounds, referred to as oxygen therapeutics, provides an opportunity to test the safety and efficacy of a new approach to management of myocardial ischemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_2

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

Study Start

First participant enrolled

April 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

May 30, 2008

Status Verified

May 1, 2008

Enrollment Period

11 months

First QC Date

May 25, 2007

Last Update Submit

May 29, 2008

Conditions

Coronary OcclusionAcute Coronary Syndrome

Keywords

Percutaneous Coronary InterventionMyocardial IschemiaBalloon OcclusionCatheter Lab

Outcome Measures

Primary Outcomes (1)

  • To study the change in left ventricular relaxation indices and pressure-half time and the change in the sum of ST segment deviations compared to baseline.

    Duration of the study

Secondary Outcomes (1)

  • LV hemodynamics; change of ST segment; QCA analysis before and after the no-infusion control occlusion and HBOC-201 infusion/occlusion; safety endpoints

    Duration of the study

Study Arms (2)

1

OTHER

Occlusion with pre-oxygenated HBOC-201 followed by dry occlusion

Drug: Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)

2

OTHER

Dry occlusion followed by occlusion with pre-oxygenated HBOC-201

Drug: Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)

Interventions

Hemoglobin Based Oxygen Carrier-201 (HBOC-201, Hemopure)DRUG

Pre-oxygenated HBOC-201

12

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent before initiation of any study-related procedure and agreement to comply with all protocol-specific procedures
  • Stable angina pectoris (CCS Class 1, 2, 3, 4) or unstable angina (Braundwald class 1-3, B) or documented silent ischemia
  • Baseline ECG with stable sinus rhythm and no signs of ischemia and with no Q waves, bundle branch block or IV conduction disturbances.
  • Normal left ventricular wall motion on left ventricular angiogram or on echocardiogram with preserved systolic global LV function
  • Non-occlusive stenosis, located in the proximal segments of the left anterior descending artery (LAD) (segments 6 and/or 7) and/or circumflex artery (CFX) (segments 11 and/or 12) or right coronary artery (RCA) (segments 1, 2 and/or 3) for which there is clinical indication to percutaneous treatment with coronary stenting
  • Successful PCI with stenting on the target vessel
  • Older than 18 years and younger than 80 years of age

You may not qualify if:

  • Active ischemia at the initiation of the study procedure
  • Non-ST segment elevation myocardial infarction
  • History or ECG evidence of prior MI in the territory supplied by the vessel undergoing PCI, IV conduction defects/baseline ST-segment abnormalities on the surface ECG
  • Moderate to severe aortic or mitral valve disease
  • Evidence of LV hypertrophy on the echocardiogram IVS \> 13 and/or PW \> 13mm
  • Angiographically visible collateral vessels to the target vessel
  • Hypertension not adequately controlled by anti-hypertensive therapy at the time of study entry (\> 140/100mmHg)
  • Uncompensated congestive heart failure or signs of pulmonary edema
  • Significant hemodynamic compromise and/or cardiogenic shock requiring inotropic or pressor support
  • Contraindications to standard drugs for coronary intervention and coronary heart disease: aspirin, heparin, low molecular weight heparin, clopidogrel, contrast dye
  • Confirmed pregnancy
  • Systemic mastocytosis
  • Hypoxemia (need for mechanical ventilation
  • Known history of COPD with FEV 1s \< 1.0 liter
  • Renal impairment: creatinine \> 1.6 mg/dl
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thoraxcentre - Erasmus MC

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Coronary OcclusionAcute Coronary SyndromeMyocardial Ischemia

Interventions

HBOC 201

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • A. Gerson Greenburg, MD, PhD

    Biopure Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 25, 2007

First Posted

May 28, 2007

Study Start

April 1, 2007

Primary Completion

March 1, 2008

Study Completion

April 1, 2008

Last Updated

May 30, 2008

Record last verified: 2008-05

Locations

NL(1)