None listed
Conditions
Brief summary
This study aims to investigate the safety and tolerability of intramuscular DVC1-0101 injections, at both high and low doses, when compared with placebo, in patients with intermittent claudication or critical limb ischaemia secondary to peripheral arterial disease. The secondary aims are to investigate the efficacy of DVC1-0101, compared with placebo, in promoting revascularisation in the target leg limb. Enrolled participants will receive a single dose (30 intramuscular injections) in the target limb. They will be required to return for regular outpatient visits over a 6 month follow up period. A final follow up phone call will be conducted at 12 months post-dose. Safety and tolerability will be measured via physical examination, clinical laboratory results and monitoring of injection site reactions. Secondary efficacy outcomes include exercise treadmill testing to obtain absolute claudication distance (ACD) and patient self-reported walking impairment data. Blood samples will be collected for pharmacodynamic measurements. The results of the study will be used to develop DVC1-0101 as a treatment for patients with claudication and critical limb ischaemia.
Interventions
A single dose (30 intramuscular injections) of DVC1-0101 or placebo will be administered to the affected lower leg limb. The doses planned for this study are:
* DVC1-0101, 5 x 10^9 ciu/patient (High dose)
* DVC1-0101, 1 x 10^9 ciu/patient (Low dose)
* Placebo
Participants will be invited to participate in an optional extension period following completion of a six month period (open-label), All participants in the extension period will receive a single dose (30 IM injections) of DVC1-0101, 5 x 1
A single dose (30 intramuscular injections) of DVC1-0101 or placebo will be administered to the affected lower leg limb. The doses planned for this study are: * DVC1-0101, 5 x 10^9 ciu/patient (High dose) * DVC1-0101, 1 x 10^9 ciu/patient (Low dose) * Placebo Participants will be invited to participate in an optional extension period following completion of a six month period (open-label), All participants in the extension period will receive a single dose (30 IM injections) of DVC1-0101, 5 x 10^9 ciu/patient (High dose). The study drug will be administered in the clinical research unit to the lower limb of the most affected leg. Thirty intramuscular injections will be administered to pre-determined locations between the knee and ankle.
Sponsors
CMAX - a division of IDT Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of PAD secondary to atherosclerosis, confirmed by medical history and one of the following observed in either leg at the screening visit: a. Resting ABI less than or equal to 0.90 b. Resting ABI greater than 0.90 and less than or equal to 1.30, with a reduction of greater than or equal to 0.20 in ABI when measured within 2 minutes after completion of treadmill exercise. c. TBI less than 0.75 if the subject has non-compressible calf arteries. i.e. Rutherford category 1-5. (Rutherford RJ, 1997) Claudication symptoms of stable severity for at least 3 months prior to screening OR the highest ACD from either the screening or baseline exercise treadmill test (ETT), utilizing a modified Gardner protocol, must be between 1 and 12 minutes (inclusive).
Exclusion criteria
PAD secondary to non-atherosclerotic conditions. Proximal severe obstructive disease amenable to revascularisation. Lower extremity amputation(s), including a toe amputation, which interfere(s) with walking on the treadmill. Percutaneous revascularization procedure within 3 months prior to Screening, or procedures that are planned during the study. Poorly controlled diabetes mellitus as evidenced by a haemoglobin A1C (HbA1c) > 12%. Coronary artery bypass graft surgery (CABG), open peripheral vascular revascularization, or major surgical procedures within 3 months prior to screening, or planned at any time during the study Unstable cardiovascular disease (CVD), defined as unstable both by clinical criteria and / or major changes in medication within 3 months prior to Screening or Baseline of the Extension Period. History of congestive heart failure (CHF) or presence of CHF as defined by modified Framingham criteria class II- IV. Myocardial infarction (MI) within 3 months prior to Screening or at Baseline of the Extension Period.
Outcome results
None listed