Trial Outcomes & Findings for Study of Hepatocyte Growth Factor (HGF) Via Plasmid Vector to Improve Perfusion in Critical Limb Ischemia Patients With Peripheral Ischemic Ulcers (NCT NCT00189540)
NCT ID: NCT00189540
Last Updated: 2021-10-28
Results Overview
Wound healing measured by change in mean total wound area of all ischemic ulcers at Month 3 and Month 6
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Baseline, Month 3, Month 6
Results posted on
2021-10-28
Participant Flow
Screening was up to 30 days
Participant milestones
| Measure |
Active Group
4.0 mg AMG0001 via IM injections on days 0, 14, and 28
|
Placebo Group
Placebo (saline)via IM injections on days 0, 14, and 28
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
6
|
|
Overall Study
COMPLETED
|
14
|
5
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
| Measure |
Active Group
4.0 mg AMG0001 via IM injections on days 0, 14, and 28
|
Placebo Group
Placebo (saline)via IM injections on days 0, 14, and 28
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Death
|
4
|
1
|
Baseline Characteristics
Study of Hepatocyte Growth Factor (HGF) Via Plasmid Vector to Improve Perfusion in Critical Limb Ischemia Patients With Peripheral Ischemic Ulcers
Baseline characteristics by cohort
| Measure |
Active Group
n=21 Participants
4.0 mg AMG0001 via IM injections on days 0, 14, and 28
|
Placebo Group
n=6 Participants
Placebo (saline)via IM injections on days 0, 14, and 28
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.7 years
STANDARD_DEVIATION 2.49 • n=5 Participants
|
78.0 years
STANDARD_DEVIATION 1.86 • n=7 Participants
|
76.2 years
STANDARD_DEVIATION 1.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6Population: Per protocol population - Efficacy Evaluable or EE
Wound healing measured by change in mean total wound area of all ischemic ulcers at Month 3 and Month 6
Outcome measures
| Measure |
Active Group
n=16 Participants
4.0 mg AMG0001 via IM injections on days 0, 14, and 28
|
Placebo Group
n=5 Participants
Placebo (saline)via IM injections on days 0, 14, and 28
|
|---|---|---|
|
Wound Healing (Change in Total Wound Area of All Ischemic Ulcers)
Baseline
|
5.75 total wound area (cm^2)
Standard Error 1.8134
|
12.600 total wound area (cm^2)
Standard Error 9.4435
|
|
Wound Healing (Change in Total Wound Area of All Ischemic Ulcers)
Month 3
|
15.766 total wound area (cm^2)
Standard Error 6.8421
|
12.200 total wound area (cm^2)
Standard Error 8.7022
|
|
Wound Healing (Change in Total Wound Area of All Ischemic Ulcers)
Month 6
|
16.375 total wound area (cm^2)
Standard Error 7.1336
|
12.700 total wound area (cm^2)
Standard Error 9.7190
|
SECONDARY outcome
Timeframe: Month 3 and Month 6Population: Per protocol population Efficacy Evaluable "EE"
This outcome is a percentage of participants where all of their baseline ulcers healed.
Outcome measures
| Measure |
Active Group
n=16 Participants
4.0 mg AMG0001 via IM injections on days 0, 14, and 28
|
Placebo Group
n=5 Participants
Placebo (saline)via IM injections on days 0, 14, and 28
|
|---|---|---|
|
Percentage of Participants Where All Ulcers Healed
Month 3
|
6 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Where All Ulcers Healed
Month 6
|
19 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Where All Ulcers Healed
Month 12
|
31 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3 and Month 6Population: Per protocol population or Efficacy Evaluable "EE"
The mean VAS score where 0 = no pain; 10 = worst possible pain.
Outcome measures
| Measure |
Active Group
n=16 Participants
4.0 mg AMG0001 via IM injections on days 0, 14, and 28
|
Placebo Group
n=5 Participants
Placebo (saline)via IM injections on days 0, 14, and 28
|
|---|---|---|
|
Change in Pain at Rest as Measured on the Visual Analog Scale (VAS)
Baseline
|
5.31 cm
Standard Error 0.60
|
6.04 cm
Standard Error 1.20
|
|
Change in Pain at Rest as Measured on the Visual Analog Scale (VAS)
Month 3
|
4.26 cm
Standard Error 0.92
|
6.52 cm
Standard Error 1.5
|
|
Change in Pain at Rest as Measured on the Visual Analog Scale (VAS)
Month 6
|
3.40 cm
Standard Error 0.99
|
6.66 cm
Standard Error 1.3
|
SECONDARY outcome
Timeframe: Month 3 and Month 6Outcome measures
| Measure |
Active Group
n=16 Participants
4.0 mg AMG0001 via IM injections on days 0, 14, and 28
|
Placebo Group
n=5 Participants
Placebo (saline)via IM injections on days 0, 14, and 28
|
|---|---|---|
|
Number of Subjects Who Undergo a Major Amputation
3 months
|
3 participants
|
0 participants
|
|
Number of Subjects Who Undergo a Major Amputation
6 months
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: Population is per protocol - Efficacy Evaluable (EE)
Outcome measures
| Measure |
Active Group
n=16 Participants
4.0 mg AMG0001 via IM injections on days 0, 14, and 28
|
Placebo Group
n=5 Participants
Placebo (saline)via IM injections on days 0, 14, and 28
|
|---|---|---|
|
Change in Hemodynamic Measurements - Mean Change in Ankle Brachial Index (ABI)
Baseline
|
0.492 mm Hg / mm Hg
Standard Error 0.0662
|
0.430 mm Hg / mm Hg
Standard Error 0.0957
|
|
Change in Hemodynamic Measurements - Mean Change in Ankle Brachial Index (ABI)
Month 3
|
0.476 mm Hg / mm Hg
Standard Error 0.0657
|
0.448 mm Hg / mm Hg
Standard Error 0.1248
|
|
Change in Hemodynamic Measurements - Mean Change in Ankle Brachial Index (ABI)
Month 6
|
0.472 mm Hg / mm Hg
Standard Error 0.0846
|
0.303 mm Hg / mm Hg
Standard Error 0.1481
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: Population is per protocol - Efficacy Evaluable (EE)
Outcome measures
| Measure |
Active Group
n=16 Participants
4.0 mg AMG0001 via IM injections on days 0, 14, and 28
|
Placebo Group
n=5 Participants
Placebo (saline)via IM injections on days 0, 14, and 28
|
|---|---|---|
|
Change in Hemodynamic Measurements - Mean Change in Toe Brachial Index (TBI)
Baseline
|
0.19 mm Hg / mm Hg
Standard Error 0.04
|
0.28 mm Hg / mm Hg
Standard Error 0.06
|
|
Change in Hemodynamic Measurements - Mean Change in Toe Brachial Index (TBI)
Month 3
|
0.22 mm Hg / mm Hg
Standard Error 0.05
|
0.14 mm Hg / mm Hg
Standard Error 0.06
|
|
Change in Hemodynamic Measurements - Mean Change in Toe Brachial Index (TBI)
Month 6
|
0.24 mm Hg / mm Hg
Standard Error 0.06
|
0.11 mm Hg / mm Hg
Standard Error 0.07
|
Adverse Events
Active Group
Serious events: 17 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo Group
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Group
n=21 participants at risk
4.0 mg AMG0001 via IM injections on days 0, 14, and 28
|
Placebo Group
n=6 participants at risk
Placebo (saline)via IM injections on days 0, 14, and 28
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/21
|
16.7%
1/6
|
|
Cardiac disorders
Cardiac Failure Congestive
|
4.8%
1/21
|
0.00%
0/6
|
|
General disorders
Death
|
4.8%
1/21
|
0.00%
0/6
|
|
General disorders
Multi-organ failure
|
4.8%
1/21
|
0.00%
0/6
|
|
General disorders
Oedema Peripheral
|
4.8%
1/21
|
0.00%
0/6
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/21
|
16.7%
1/6
|
|
Infections and infestations
Cellulitis
|
0.00%
0/21
|
33.3%
2/6
|
|
Infections and infestations
Lobar Pneumonia
|
4.8%
1/21
|
0.00%
0/6
|
|
Infections and infestations
Osteomyelitis
|
14.3%
3/21
|
0.00%
0/6
|
|
Infections and infestations
Pneumonia
|
9.5%
2/21
|
16.7%
1/6
|
|
Infections and infestations
Sepsis
|
4.8%
1/21
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
4.8%
1/21
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Dehydration
|
9.5%
2/21
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
4.8%
1/21
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.8%
1/21
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/21
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
4.8%
1/21
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Gouty Arthritis
|
4.8%
1/21
|
0.00%
0/6
|
|
Nervous system disorders
Cerebrovascular accident
|
4.8%
1/21
|
16.7%
1/6
|
|
Psychiatric disorders
Depression
|
4.8%
1/21
|
0.00%
0/6
|
|
Psychiatric disorders
Mental Status Change
|
4.8%
1/21
|
0.00%
0/6
|
|
Surgical and medical procedures
Knee Arthroplasty
|
4.8%
1/21
|
0.00%
0/6
|
|
Vascular disorders
Aortic thrombosis
|
4.8%
1/21
|
0.00%
0/6
|
|
Vascular disorders
Ischaemic ulcer
|
4.8%
1/21
|
0.00%
0/6
|
|
Vascular disorders
Peripheral Arterial occlusive disease
|
42.9%
9/21
|
33.3%
2/6
|
|
Infections and infestations
Localised Infection
|
9.5%
2/21
|
0.00%
0/6
|
Other adverse events
| Measure |
Active Group
n=21 participants at risk
4.0 mg AMG0001 via IM injections on days 0, 14, and 28
|
Placebo Group
n=6 participants at risk
Placebo (saline)via IM injections on days 0, 14, and 28
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
7/21
|
50.0%
3/6
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/21
|
16.7%
1/6
|
|
Cardiac disorders
Angina Pectoris
|
4.8%
1/21
|
16.7%
1/6
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/21
|
16.7%
1/6
|
|
Cardiac disorders
Cardiac Failure Congestive
|
9.5%
2/21
|
0.00%
0/6
|
|
Cardiac disorders
Myocardial Infarction
|
9.5%
2/21
|
0.00%
0/6
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/21
|
16.7%
1/6
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/21
|
16.7%
1/6
|
|
Gastrointestinal disorders
Constipation
|
23.8%
5/21
|
16.7%
1/6
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
3/21
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/21
|
16.7%
1/6
|
|
Gastrointestinal disorders
Nausea
|
4.8%
1/21
|
50.0%
3/6
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21
|
16.7%
1/6
|
|
General disorders
Injection Site Discomfort
|
9.5%
2/21
|
0.00%
0/6
|
|
General disorders
Oedema Peripheral
|
23.8%
5/21
|
16.7%
1/6
|
|
General disorders
Pyrexia
|
23.8%
5/21
|
16.7%
1/6
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/21
|
16.7%
1/6
|
|
Infections and infestations
Cellulitis
|
9.5%
2/21
|
50.0%
3/6
|
|
Infections and infestations
Localised infection
|
9.5%
2/21
|
0.00%
0/6
|
|
Infections and infestations
Osteomyelitis
|
23.8%
5/21
|
0.00%
0/6
|
|
Infections and infestations
Sepsis
|
9.5%
2/21
|
0.00%
0/6
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/21
|
16.7%
1/6
|
|
Infections and infestations
Urinary Tract Infection
|
19.0%
4/21
|
16.7%
1/6
|
|
Injury, poisoning and procedural complications
Contusion
|
9.5%
2/21
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Excoriation
|
9.5%
2/21
|
0.00%
0/6
|
|
Investigations
Blood creatinine increased
|
4.8%
1/21
|
16.7%
1/6
|
|
Investigations
Blood lactate dehydrogenase increased
|
4.8%
1/21
|
16.7%
1/6
|
|
Investigations
Blood urea increased
|
4.8%
1/21
|
16.7%
1/6
|
|
Investigations
Blood uric acid increased
|
0.00%
0/21
|
16.7%
1/6
|
|
Investigations
Chest x-ray abnormal
|
9.5%
2/21
|
0.00%
0/6
|
|
Investigations
Creatinine renal clearance decreased
|
4.8%
1/21
|
16.7%
1/6
|
|
Investigations
Electrocardiogram abnormal
|
9.5%
2/21
|
16.7%
1/6
|
|
Investigations
International normalised ratio increased
|
9.5%
2/21
|
0.00%
0/6
|
|
Investigations
Occult blood positive
|
0.00%
0/21
|
16.7%
1/6
|
|
Investigations
White blood cell count increased
|
14.3%
3/21
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
3/21
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
9.5%
2/21
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
19.0%
4/21
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.8%
1/21
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.8%
1/21
|
16.7%
1/6
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/21
|
16.7%
1/6
|
|
Nervous system disorders
Aphasia
|
0.00%
0/21
|
16.7%
1/6
|
|
Nervous system disorders
Cerebrovascular accident
|
19.0%
4/21
|
33.3%
2/6
|
|
Nervous system disorders
Depressed level of conciousness
|
0.00%
0/21
|
16.7%
1/6
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/21
|
16.7%
1/6
|
|
Nervous system disorders
Headache
|
0.00%
0/21
|
16.7%
1/6
|
|
Psychiatric disorders
Agitation
|
0.00%
0/21
|
16.7%
1/6
|
|
Psychiatric disorders
Confusional state
|
14.3%
3/21
|
33.3%
2/6
|
|
Psychiatric disorders
Depression
|
9.5%
2/21
|
0.00%
0/6
|
|
Psychiatric disorders
Auditory hallucination
|
0.00%
0/21
|
16.7%
1/6
|
|
Renal and urinary disorders
Renal failure acute
|
19.0%
4/21
|
0.00%
0/6
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/21
|
33.3%
2/6
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.5%
2/21
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
9.5%
2/21
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
9.5%
2/21
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.0%
4/21
|
16.7%
1/6
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/21
|
16.7%
1/6
|
|
Vascular disorders
Hypertension
|
9.5%
2/21
|
0.00%
0/6
|
|
Vascular disorders
Hypotension
|
4.8%
1/21
|
16.7%
1/6
|
|
Vascular disorders
Ischaemic limb pain
|
9.5%
2/21
|
0.00%
0/6
|
|
Vascular disorders
Ischaemic ulcer
|
38.1%
8/21
|
16.7%
1/6
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
52.4%
11/21
|
33.3%
2/6
|
|
Vascular disorders
Peripheral ischaemia
|
4.8%
1/21
|
16.7%
1/6
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/21
|
16.7%
1/6
|
|
Infections and infestations
Furuncle
|
0.00%
0/21
|
16.7%
1/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Multi-center all inclusive initial publication planned. Any proposed publications must be submitted to the steering committee and sponsor thirty (30) days prior to publication submission.
- Publication restrictions are in place
Restriction type: OTHER