Peripheral Vascular DiseasePhase 2NCT00300040
Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia
A Phase 2 study testing Hemoglobin glutamer 250 - bovine and 6% Hydroxyethylstarch in people with Peripheral Vascular Disease, run by Biopure Corporation at 5 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Hemoglobin glutamer 250 - bovine and 6% Hydroxyethylstarch
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 5 sitesin 2 countries
- Study dates
- May 2006to Jun 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
South Africa4 sites
Johannesburg Hospital
Johannesburg, Guateng, 2041
Milpark Hospital
Parktown West, Guateng, 2193
Pretoria Academic Hospital
Pretoria, Guateng, 0001
University of Stellenbosch
Tygerburg, 7506
United Kingdom1 site
John Radcliffe Hospital
Headington, Oxfordshire, OX3 9DU
About this study
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
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.
Read the 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%).
- Conditions
- Peripheral Vascular Disease
- Being tested
- Hemoglobin glutamer 250 - bovine, 6% Hydroxyethylstarch
- Keywords
- Amputation, Lower limb, Critical Limb Ischemia, residual limb, Peripheral Vascular Disease, re-amputation, Lower Limb Ischemia, PVD
- Medical subject headings
- Peripheral Vascular Diseases, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemoglobin glutamer 250 - bovineDrug
Also called Hemopure, HBOC-201
intravenous - 250ml/dose - 32.5g Hb (Concentration 13 +/- 1g/dL)
6% HydroxyethylstarchDrug
Also called HAES-steril®
250ml for intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Hemoglobin glutamer 250 - bovine Receives: Drug: Hemoglobin glutamer 250 - bovine |
| 2 | Active comparator | 6% Hydroxyethylstarch Receives: Drug: 6% Hydroxyethylstarch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 60 days post amputation procedure
Measured: 60(±7 days) post-procedure follow-up visit
Secondary outcomes (1)
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
Measured: 15(±3 days) , 30(±7 days) and 60(±7 days) post-procedure follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2006 (estimated)
- Study startMay 2006
- Primary completionJun 2008 (estimated)
- Study completionJun 2008 (estimated)
Why it stopped: Very slow enrollment.Study entry criteria not in line w/local standards of care
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biopure Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- A. Gerson Greenburg, MD, Ph.D., Study director, Biopure Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300040
- Sponsor's protocol ID
- BIOSA001/BIOEU001
- Status last verified
- May 2008
- First submitted
- 6 Mar 2006
- Last updated
- 16 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00300040
- Acronym / sponsor ID
- BIOSA001/BIOEU001
- Conditions
- Peripheral Vascular Disease
- Keywords
- Amputation, Lower limb, Critical Limb Ischemia, residual limb, Peripheral Vascular Disease, re-amputation, Lower Limb Ischemia, PVD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Very slow enrollment.Study entry criteria not in line w/local standards of care
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Biopure CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jun 2008 (estimated)
- Study completion
- Jun 2008 (estimated)
- First posted
- 8 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Hemoglobin glutamer 250 - bovineHemoglobin glutamer 250 - bovine |
| 2 | Active comparator | Drug: 6% Hydroxyethylstarch6% Hydroxyethylstarch |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Participant or legal representative signs informed consent
- Willingness to follow study instructions and follow-up visits
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemoglobin glutamer 250 - bovineAlso: Hemopure, HBOC-201intravenous - 250ml/dose - 32.5g Hb (Concentration 13 +/- 1g/dL) | Drug | 1 |
| 6% HydroxyethylstarchAlso: HAES-steril®250ml for intravenous infusion | Drug | 2 |
Primary outcome
Mortality at 60 days post amputation procedure
Time frame: 60(±7 days) post-procedure follow-up visit
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Very slow enrollment.Study entry criteria not in line w/local standards of care). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A. Gerson Greenburg, MD, Ph.D. study director
Biopure Corporation
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hemoglobin glutamer 250 - bovine and 6% Hydroxyethylstarch in people with Peripheral Vascular Disease, run by Biopure Corporation at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Africa, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Very slow enrollment.Study entry criteria not in line w/local standards of care). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at 60 days post amputation procedure (time frame: 60(±7 days) post-procedure follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2008.