Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia

This study has been terminated.
(Very slow enrollment.Study entry criteria not in line w/local standards of care)
Sponsor:
Information provided by:
Biopure Corporation
ClinicalTrials.gov Identifier:
NCT00300040
First received: March 6, 2006
Last updated: May 15, 2008
Last verified: May 2008
  Purpose

The purpose of this study is to assess the safety and feasibility of HBOC-201 in increasing adequate wound healing in patients with severe peripheral vascular disease who are undergoing lower limb amputation.

The hypothesis is that HBOC-201 will pass through the partially occluded lesions in the peripheral arteries in the lower extremity and promote the wound healing process by delivering oxygen to the oxygen deprived tissues. This will reduce the incidence of lower limb wound complications at 60 days post-surgery and may reduce the incidence of a second amputation.


Condition Intervention Phase
Peripheral Vascular Disease
Drug: Hemoglobin glutamer 250 - bovine
Drug: 6% Hydroxyethylstarch
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase II, Multi-Center,Single-Blind,Placebo-Controlled Study,Evaluating Safety & Feasibility of HBOC-201 (Wound Healing Patients With Peripheral Vascular Disease & Undergoing Lower Limb Amputation Due to Critical Lower Limb Ischemia

Resource links provided by NLM:


Further study details as provided by Biopure Corporation:

Primary Outcome Measures:
  • Mortality at 60 days post amputation procedure [ Time Frame: 60(±7 days) post-procedure follow-up visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 30 day follow up mortality; Complete wound healing 30, 60 day follow up; Time to complete wound healing; Re-amputation 60 days; Hospital, ICU & rehab days; TcPO2 change; Quality of Life; Delayed wound healing/complications; Rehospitalization; Surgeries [ Time Frame: 15(±3 days) , 30(±7 days) and 60(±7 days) post-procedure follow-up visits ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: May 2006
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Hemoglobin glutamer 250 - bovine
Drug: Hemoglobin glutamer 250 - bovine
intravenous - 250ml/dose - 32.5g Hb (Concentration 13 +/- 1g/dL)
Other Names:
  • Hemopure
  • HBOC-201
Active Comparator: 2
6% Hydroxyethylstarch
Drug: 6% Hydroxyethylstarch
250ml for intravenous infusion
Other Name: HAES-steril®

Detailed Description:

This is a Phase II, single-blinded, prospectively randomized, parallel-group, placebo controlled study that will evaluate the safety and feasibility of HBOC-201 when administered therapeutically to patients with a peripheral vascular occlusive disorder and who are undergoing lower limb amputation due to critical lower limb ischemia. Subjects will be randomized (1:1) to receive either HBOC-201 or a colloid control (HAES-steril® 6%).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects ≥ 18 ≤ 75 years of age
  • Scheduled amputation at or above ankle joint, or a more proximal location but below or through the knee joint
  • Documented severe lower extremity peripheral artery occlusive disease confirmed by clinical symptoms of critical limb ischemia and:

    • Frankly gangrenous tissue that merits amputation or
    • Angiographic evidence of occlusive peripheral artery disease within one month of screening
  • Participant or legal representative signs informed consent
  • Willingness to follow study instructions and follow-up visits

Exclusion Criteria:

  • No informed consent is obtained
  • If medically inappropriate to administer 250 mL colloidal solution daily for 4 consecutive days
  • Uncontrolled hypertension (BP > 160/90 mm Hg) despite 2 antihypertensive meds or BP > 180/100 mm Hg if untreated
  • Severe liver dysfunction defined by Total Bilirubin > 3 mg/dL or twice the normal limit of serum AST or ALT
  • Symptomatic CVD diagnosed w/ in last 6 months or known high grade carotid stenosis
  • Any severe or unstable medical condition that might interfere w/ the evaluation of study medication
  • Cardiogenic shock (cardiac index < 2 L/min/m2, PCWP > 18 mm Hg)
  • Amputation above knee joint or below ankle joint
  • Any amputation whereby primary skin closure not technically feasible
  • Candidate for percutaneous or surgical revascularization
  • Cardiac failure defined by a NY class III/IV or left ventricular ejection fraction < 30%
  • Life expectancy < 60 days
  • Systemic mastocytosis
  • Previously demonstrated beef product allergy
  • Myocardial infarction w/ in 30 days
  • Participation in another trial w/ in last 30 days
  • Woman who is pregnant or breastfeeding
  • Amputation with known infection at site of skin closure
  • Renal dysfunction requiring dialysis, or serum creatinine level 2.5 mg/dL
  • Peripheral vascular occlusion from cardio arterial emboli
  • Uncontrolled diabetes blood glucose ≥ 400 mg/dL
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300040

Locations
South Africa
Johannesburg Hospital
Johannesburg, Guateng, South Africa, 2041
Milpark Hospital
Parktown West, Guateng, South Africa, 2193
Pretoria Academic Hospital
Pretoria, Guateng, South Africa, 0001
University of Stellenbosch
Tygerburg, South Africa, 7506
United Kingdom
John Radcliffe Hospital
Headington, Oxfordshire, United Kingdom, OX3 9DU
Sponsors and Collaborators
Biopure Corporation
Investigators
Study Director: A. Gerson Greenburg, MD, Ph.D. Biopure Corporation
  More Information

No publications provided

Responsible Party: Biopure
ClinicalTrials.gov Identifier: NCT00300040     History of Changes
Other Study ID Numbers: BIOSA001/BIOEU001
Study First Received: March 6, 2006
Last Updated: May 15, 2008
Health Authority: South Africa: Medicines Control Council
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Biopure Corporation:
Amputation
Lower limb
Critical Limb Ischemia
residual limb
Peripheral Vascular Disease
re-amputation
Lower Limb Ischemia
PVD

Additional relevant MeSH terms:
Vascular Diseases
Ischemia
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
HBOC 201
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014