E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Wound Healing in Patients with Peripheral Vascular Disease and Who are Undergoing a Lower Limb Amputation due to Critical Lower Limb Ischemia |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is:
1) to evaluate the safety of HBOC-201 in people who have peripheral vascular disease and who are having a lower limb amputation |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are:
1) to determine if HBOC-201 (Hemopure®) can enhance wound healing in patients with advanced peripheral vascular disease who are having a through or below-the-knee but above the ankle amputation.
2) to determine if HBOC-201 will reduce wound complications and thus reduce the need for re-amputation at a higher level. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
-Subjects >18 years of age and <75 years of age -Patients are scheduled for amputation at or above the ankle joint or a more proximal location but below or through the knee joint -Patients have a 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 -Patient or legal representative is willing to sign informed consent -Patient is willing to follow the study instructions and follow-up visit |
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E.4 | Principal exclusion criteria |
Patients with life expectancy less than 60 days. -Any patient in whom the administration of 250 mL of colloidal solution daily for four consecutive days would be considered medically inappropriate. -Patient has amputation above the knee joint or below the ankle joint. -Patient has any amputation whereby primary skin closure is not technically feasible (e.g. Guillotine). These patients can later be randomized at the time of definitive amputation provided they meet the inclusion criteria. -Patient has any amputation in which there is known infection at the site of skin closure, unless the infection is successfully treated prior to enrollment. -Patient is a candidate for percutaneous or open surgery revascularization. -Patient with peripheral vascular occlusion due to a cardioarterial emboli. -Patient is a pregnant or breastfeeding woman. -Previously demonstrated beef product allergy. -Renal dysfunction requiring dialysis, or serum creatinine level >2.50 mg/dL(>220 micromol/L) -Cardiac failure as defined by a NY class III/IV or left ventricular ejection fraction < 30% -Myocardial infarction within the last 30 days -Patients with cardiogenic shock (defined by a cardiac index < 2 L/min/m2 PCWP > 18 mm Hg) -Symptomatic cerebrovascular disease (e.g., stroke) diagnosed within last 6 months or known high grade carotid stenosis -Uncontrolled diabetes as defined by a blood glucose ≥ 400 mg/dL ( ≥ 22 mmol/L) -Patients with uncontrolled hypertension as defined by a blood pressure > 160 / 90 mm Hg despite the use of at least two antihypertensive medications or > 180 / 100 mm Hg if untreated -Severe liver dysfunction as defined by total bilirubin ≥ 3 mg/dL ( ≥ 51 micromol/L) or an increase two times over the normal level of serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) -Systemic mastocytosis -Participation in another trial with an investigational drug or device including the follow-up period, within the last 30 days before enrollment -Severe or unstable hepatic, gastrointestinal, cardiovascular, respiratory, neurological, psychiatric, hematological, renal or dermatological disease, or any other medical condition that might interfere with the evaluation of study medication -Patient or legal representative is unable to provide informed consent
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point of this study is: Safety of Product (60 day mortality)
The secondary end point of this study is:
Effect of product on wound healing. Specifically if wound healing is more complete than control (placebo) group and if the incidence of re-amputation is decreased. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |