Trial Outcomes & Findings for A Phase IIB Pilot Study of a Modified Dosage Regimen of AMG0001 in Subjects With Critical Limb Ischemia (NCT NCT02016755)
NCT ID: NCT02016755
Last Updated: 2021-01-22
Results Overview
All summaries and analyses will be presented in tabular or graphical form. The study is not powered for the statistical inference and the test will be considered to be descriptive. Treatment-emergent adverse events (TEAEs) was evaluated, and a table showing the number and percentage of subjects with occurrences categorized by System Organ Class and Preferred Term was provided by causality (relationship to study drug).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
18 months
Results posted on
2021-01-22
Participant Flow
10 subjects were enrolled at a single clinical site.
Participant milestones
| Measure |
AMG0001
Hepatocyte Growth Factor (HGF) Plasmid
HGF Plasmid: Intramuscular injection in the affected limb.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
Completed Month 18 Clinic Visit
|
5
|
|
Overall Study
Completed Month 36 LTFU Questionnaire
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
AMG0001
Hepatocyte Growth Factor (HGF) Plasmid
HGF Plasmid: Intramuscular injection in the affected limb.
|
|---|---|
|
Overall Study
Major amputation of index limb
|
2
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Death
|
2
|
Baseline Characteristics
A Phase IIB Pilot Study of a Modified Dosage Regimen of AMG0001 in Subjects With Critical Limb Ischemia
Baseline characteristics by cohort
| Measure |
AMG0001
n=10 Participants
Hepatocyte Growth Factor (HGF) Plasmid
HGF Plasmid: Intramuscular injection in the affected limb.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Weight (kg)
|
81.58 kg
STANDARD_DEVIATION 11.052 • n=5 Participants
|
|
Height (cm)
|
171.70 cm
STANDARD_DEVIATION 5.921 • n=5 Participants
|
|
Past Tobacco Use
Yes - Smoking
|
10 Participants
n=5 Participants
|
|
Past Tobacco Use
No
|
0 Participants
n=5 Participants
|
|
Current Tobacco Use
Yes - Smoking
|
1 Participants
n=5 Participants
|
|
Current Tobacco Use
No
|
9 Participants
n=5 Participants
|
|
Alcohol Use
Yes - 1 to 2 drinks per day or less
|
5 Participants
n=5 Participants
|
|
Alcohol Use
Yes - 3 drinks per day or more
|
1 Participants
n=5 Participants
|
|
Alcohol Use
No
|
4 Participants
n=5 Participants
|
|
Mobility
None
|
0 Participants
n=5 Participants
|
|
Mobility
Some
|
7 Participants
n=5 Participants
|
|
Mobility
Confined
|
1 Participants
n=5 Participants
|
|
Mobility
Missing
|
2 Participants
n=5 Participants
|
|
Ability to Self-care
None
|
5 Participants
n=5 Participants
|
|
Ability to Self-care
Some
|
4 Participants
n=5 Participants
|
|
Ability to Self-care
Unable
|
0 Participants
n=5 Participants
|
|
Ability to Self-care
Missing
|
1 Participants
n=5 Participants
|
|
Anxiety/Depression
None
|
4 Participants
n=5 Participants
|
|
Anxiety/Depression
Moderate
|
5 Participants
n=5 Participants
|
|
Anxiety/Depression
Extreme
|
0 Participants
n=5 Participants
|
|
Anxiety/Depression
Missing
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Not every subject analyzed may experience an adverse event likely related or possibly related to injections of AMG0001; therefore, the subject counts in the categories do not always add up to the total number analyzed
All summaries and analyses will be presented in tabular or graphical form. The study is not powered for the statistical inference and the test will be considered to be descriptive. Treatment-emergent adverse events (TEAEs) was evaluated, and a table showing the number and percentage of subjects with occurrences categorized by System Organ Class and Preferred Term was provided by causality (relationship to study drug).
Outcome measures
| Measure |
AMG0001
n=10 Participants
Hepatocyte Growth Factor (HGF) Plasmid
HGF Plasmid: Intramuscular injection in the affected limb.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) Suspected to be Related to Injections of AMG0001
General disorders & admin site conditions (Mild)
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) Suspected to be Related to Injections of AMG0001
Infections and infestations (Mild)
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) Suspected to be Related to Injections of AMG0001
Investigations (Moderate)
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) Suspected to be Related to Injections of AMG0001
Eye disorders (Moderate)
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) Suspected to be Related to Injections of AMG0001
Vascular disorders (Severe)
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) Suspected to be Related to Injections of AMG0001
Neoplasms benign, malignant, unspecified (Severe)
|
1 Participants
|
PRIMARY outcome
Timeframe: up to 18 MonthsAll summaries and analyses will be presented in tabular or graphical form. The study is not powered for the statistical inference and the test will be considered to be descriptive. Treatment-emergent adverse events (TEAEs) was evaluated, and a table showing the number and percentage of subjects with occurrences categorized by System Organ Class and Preferred Term was provided by whether the AE led to discontinuation.
Outcome measures
| Measure |
AMG0001
n=10 Participants
Hepatocyte Growth Factor (HGF) Plasmid
HGF Plasmid: Intramuscular injection in the affected limb.
|
|---|---|
|
Number of Participants Discontinued Due to AEs From the Injections of AMG0001
Macular edema (likely unrelated)
|
1 Participants
|
|
Number of Participants Discontinued Due to AEs From the Injections of AMG0001
Uterine leiomyosarcoma (possibly related)
|
1 Participants
|
SECONDARY outcome
Timeframe: 18 MonthsPopulation: 4 subjects classified as Rutherford Class 5 at Baseline had available data through Month 6; 1 subject through Month 12; 0 subject through Month 18
All summaries and analyses will be presented in tabular or graphical form. The study is not powered for the statistical inference and the test will be considered to be descriptive. A table showing the number of subjects completely healed in the target ulcer was provided at up to 6 months, \> 6 months to 12 months, from \>12 months to 18 months.
Outcome measures
| Measure |
AMG0001
n=4 Participants
Hepatocyte Growth Factor (HGF) Plasmid
HGF Plasmid: Intramuscular injection in the affected limb.
|
|---|---|
|
Number of Participants in Whom the Largest Ulcer Healed Completely or Gets Smaller (Photo Confirmation)
Day 0 to Month 6
|
0 Participants
|
|
Number of Participants in Whom the Largest Ulcer Healed Completely or Gets Smaller (Photo Confirmation)
Month 6 to Month 12
|
0 Participants
|
|
Number of Participants in Whom the Largest Ulcer Healed Completely or Gets Smaller (Photo Confirmation)
Month 12 to Month 18
|
0 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: 8 subjects had available data through Month 6; 6 subjects through Month 12; 4 subjects through Month 18
All summaries and analyses will be presented in tabular or graphical form. The study is not powered for the statistical inference and the test will be considered to be descriptive. The severity of rest pain (based on the average over previous 7 days) recorded using the 10 cm visual analog scale (VAS). VAS is a 10-cm line (with score ranges 0 to 10), oriented horizontally; the left end of the line (0 mark) indicates "no pain"; the right end indicates "pain as bad as it can be." 1. The subject is asked to mark a place on the line corresponding to the average pain intensity experienced in the last 7 days. 2. The distance along the scale is converted into a numeric reading by measuring the distance of the subjects mark in cm from the beginning of the scale (the 0 mark).
Outcome measures
| Measure |
AMG0001
n=8 Participants
Hepatocyte Growth Factor (HGF) Plasmid
HGF Plasmid: Intramuscular injection in the affected limb.
|
|---|---|
|
Number of Participants in Whom Rest Pain (Based on 10 cm VAS Scale) Reduces by 20 mm (2 cm) or More or Was Completely Relieved.
Day 0 to Month 6
|
1 Participants
|
|
Number of Participants in Whom Rest Pain (Based on 10 cm VAS Scale) Reduces by 20 mm (2 cm) or More or Was Completely Relieved.
Month 6 to Month 12
|
2 Participants
|
|
Number of Participants in Whom Rest Pain (Based on 10 cm VAS Scale) Reduces by 20 mm (2 cm) or More or Was Completely Relieved.
Month 12 to Month 18
|
2 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: At each visit, only subjects who had a non-missing value at both baseline and the specific visit was summarized.
The VascuQol contains 5 domains (pain, symptom, activities, social, and emotional functioning); responses were scored from 0 (lowest QOL, death) to 7 (best QOL, maximum health). Responses were averaged for composite overall and domain-specific scores, giving equal weight to each question and domain. The composite overall is the average of domain-specific scores. Responses after revascularization or major amputation were included in the analysis. In the event of death, subjects were scored as 0. For the effect of treatment on individual domains, pain, symptoms, and activities were considered the most important of the 5 domains.
Outcome measures
| Measure |
AMG0001
n=8 Participants
Hepatocyte Growth Factor (HGF) Plasmid
HGF Plasmid: Intramuscular injection in the affected limb.
|
|---|---|
|
Change From Baseline of VascuQol Score for the Index Limb by Visit
Overall (LOCF)
|
0.58 score on a scale
Standard Deviation 1.567
|
|
Change From Baseline of VascuQol Score for the Index Limb by Visit
Activity (LOCF)
|
0.54 score on a scale
Standard Deviation 1.562
|
|
Change From Baseline of VascuQol Score for the Index Limb by Visit
Emotional (LOCF)
|
0.52 score on a scale
Standard Deviation 0.935
|
|
Change From Baseline of VascuQol Score for the Index Limb by Visit
Pain (LOCF)
|
0.71 score on a scale
Standard Deviation 2.610
|
|
Change From Baseline of VascuQol Score for the Index Limb by Visit
Social (LOCF)
|
0.75 score on a scale
Standard Deviation 1.488
|
|
Change From Baseline of VascuQol Score for the Index Limb by Visit
Symptom (LOCF)
|
0.58 score on a scale
Standard Deviation 2.055
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: At each visit, only subjects who have non-missing values both at baseline and the specific visit was summarized.
Summary statistics was provided for baseline and change from baseline for toe systolic pressure by visit. At each visit, only subjects who have a non-missing value at both baseline and the specific visit was summarized. Two-sided one-sample t-test was performed for each visit and last observation carried forward (LOCF).
Outcome measures
| Measure |
AMG0001
n=6 Participants
Hepatocyte Growth Factor (HGF) Plasmid
HGF Plasmid: Intramuscular injection in the affected limb.
|
|---|---|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Toe Systolic Pressure (mmHg)
Change from Baseline at Month 3
|
0.5 mmHg
Standard Deviation 11.96
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Toe Systolic Pressure (mmHg)
Change from Baseline at Month 6
|
3.7 mmHg
Standard Deviation 12.60
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Toe Systolic Pressure (mmHg)
Change from Baseline at Month 9
|
5.5 mmHg
Standard Deviation 13.48
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Toe Systolic Pressure (mmHg)
Change from Baseline at Month 12
|
4.2 mmHg
Standard Deviation 9.12
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Toe Systolic Pressure (mmHg)
Change from Baseline at Month 15
|
6.7 mmHg
Standard Deviation 7.37
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Toe Systolic Pressure (mmHg)
Change from Baseline at Month 18
|
19.8 mmHg
Standard Deviation 13.33
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Toe Systolic Pressure (mmHg)
Change from Baseline at LOCF
|
16.0 mmHg
Standard Deviation 12.05
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: At each visit, only subjects who have non-missing values both at baseline and the specific visit was summarized.
Summary statistics was provided for baseline and change from baseline for ankle systolic pressure by visit. At each visit, only subjects who have a non-missing value at both baseline and the specific visit was summarized. Two-sided one-sample t-test was performed for each visit and last observation carried forward (LOCF).
Outcome measures
| Measure |
AMG0001
n=6 Participants
Hepatocyte Growth Factor (HGF) Plasmid
HGF Plasmid: Intramuscular injection in the affected limb.
|
|---|---|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit
Change from Baseline at Month 3 (Dorsalis pedis)
|
10.8 mmHg
Standard Deviation 43.50
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit
Change from Baseline at Month 6 (Dorsalis pedis)
|
40.7 mmHg
Standard Deviation 88.18
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit
Change from Baseline at Month 9 (Dorsalis pedis)
|
27.6 mmHg
Standard Deviation 58.12
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit
Change from Baseline at Month 12 (Dorsalis pedis)
|
11.5 mmHg
Standard Deviation 30.16
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit
Change from Baseline at Month 15 (Dorsalis pedis)
|
-13.3 mmHg
Standard Deviation 31.13
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit
Change from Baseline at Month 18 (Dorsalis pedis)
|
31.3 mmHg
Standard Deviation 22.81
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit
Change from Baseline at LOCF (Dorsalis pedis)
|
55.0 mmHg
Standard Deviation 39.07
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit
Change from Baseline at Month 3 (Posterior tibial)
|
10.5 mmHg
Standard Deviation 52.45
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit
Change from Baseline at Month 6 (Posterior tibial)
|
-4.8 mmHg
Standard Deviation 18.41
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit
Change from Baseline at Month 9 (Posterior tibial)
|
-8.0 mmHg
Standard Deviation 25.02
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit
Change from Baseline at Month 12 (Posterior tibial
|
2.8 mmHg
Standard Deviation 20.76
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit
Change from Baseline at Month 15 (Posterior tibial
|
-14.3 mmHg
Standard Deviation 23.18
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit
Change from Baseline at Month 18 (Posterior tibial
|
36.7 mmHg
Standard Deviation 29.28
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit
Change from Baseline at LOCF (Posterior tibial)
|
19.8 mmHg
Standard Deviation 33.66
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: At each visit, only subjects who have non-missing values both at baseline and the specific visit was summarized.
Summary statistics was provided for baseline and change from baseline for right/left brachial systolic pressure by visit. At each visit, only subjects who have a non-missing value at both baseline and the specific visit was summarized. Two-sided one-sample t-test was performed for each visit and last observation carried forward (LOCF).
Outcome measures
| Measure |
AMG0001
n=8 Participants
Hepatocyte Growth Factor (HGF) Plasmid
HGF Plasmid: Intramuscular injection in the affected limb.
|
|---|---|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg)
Change from Baseline at Month 12 (Left)
|
-6.6 mmHg
Standard Deviation 16.79
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg)
Change from Baseline at Month 3 (Right)
|
-4.5 mmHg
Standard Deviation 24.42
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg)
Change from Baseline at Month 6 (Right)
|
-1.1 mmHg
Standard Deviation 30.80
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg)
Change from Baseline at Month 9 (Right)
|
-4.2 mmHg
Standard Deviation 13.12
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg)
Change from Baseline at Month 12 (Right)
|
-9.6 mmHg
Standard Deviation 18.12
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg)
Change from Baseline at Month 15 (Right)
|
-4.3 mmHg
Standard Deviation 8.14
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg)
Change from Baseline at Month 18 (Right)
|
5.8 mmHg
Standard Deviation 15.22
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg)
Change from Baseline at LOCF (Right)
|
12.5 mmHg
Standard Deviation 20.91
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg)
Change from Baseline at Month 3 (Left)
|
-10.9 mmHg
Standard Deviation 18.67
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg)
Change from Baseline at Month 6 (Left)
|
-7.8 mmHg
Standard Deviation 20.52
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg)
Change from Baseline at Month 9 (Left)
|
-0.6 mmHg
Standard Deviation 13.90
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg)
Change from Baseline at Month 15 (Left)
|
1.0 mmHg
Standard Deviation 15.77
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg)
Change from Baseline at Month 18 (Left)
|
8.3 mmHg
Standard Deviation 13.20
|
|
Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg)
Change from Baseline at LOCF (Left)
|
6.6 mmHg
Standard Deviation 13.70
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: At each visit, only subjects who have non-missing values both at baseline and the specific visit was summarized.
Summary statistics was provided for baseline and change from baseline for toe brachial index (TBI) by visit. At each visit, only subjects who have a non-missing value at both baseline and the specific visit was summarized. Two-sided one-sample t-test was performed for each visit and last observation carried forward (LOCF). TBI was calculated by dividing the toe systolic blood pressure by the brachial systolic blood pressure. TBI was calculated at baseline and at each visit. The change in TBI at each visit compared to the baseline value was recorded.
Outcome measures
| Measure |
AMG0001
n=6 Participants
Hepatocyte Growth Factor (HGF) Plasmid
HGF Plasmid: Intramuscular injection in the affected limb.
|
|---|---|
|
Change in Hemodynamic Measurement of Baseline Calculated Toe Brachial Index (TBI) of the Index Leg by Visit
Change from Baseline at Month 3
|
0.0180 ratio
Standard Deviation 0.0709
|
|
Change in Hemodynamic Measurement of Baseline Calculated Toe Brachial Index (TBI) of the Index Leg by Visit
Change from Baseline at Month 6
|
0.040 ratio
Standard Deviation 0.0710
|
|
Change in Hemodynamic Measurement of Baseline Calculated Toe Brachial Index (TBI) of the Index Leg by Visit
Change from Baseline at Month 9
|
0.040 ratio
Standard Deviation 0.0779
|
|
Change in Hemodynamic Measurement of Baseline Calculated Toe Brachial Index (TBI) of the Index Leg by Visit
Change from Baseline at Month 12
|
0.044 ratio
Standard Deviation 0.0619
|
|
Change in Hemodynamic Measurement of Baseline Calculated Toe Brachial Index (TBI) of the Index Leg by Visit
Change from Baseline at Month 15
|
0.060 ratio
Standard Deviation 0.0557
|
|
Change in Hemodynamic Measurement of Baseline Calculated Toe Brachial Index (TBI) of the Index Leg by Visit
Change from Baseline at Month 18
|
0.123 ratio
Standard Deviation 0.0907
|
|
Change in Hemodynamic Measurement of Baseline Calculated Toe Brachial Index (TBI) of the Index Leg by Visit
Change from Baseline at LOCF
|
0.095 ratio
Standard Deviation 0.0831
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: At each visit, only subjects who have non-missing values both at baseline and the specific visit was summarized.
Summary statistics was provided for baseline and change from baseline for ankle brachial index (ABI) by visit. At each visit, only subjects who have a non-missing value at both baseline and the specific visit was summarized. Two-sided one-sample t-test was performed for each visit and last observation carried forward (LOCF). ABI was calculated by dividing the ankle systolic blood pressure by the brachial systolic blood pressure. ABI was calculated at baseline and at each visit. The change in ABI at each visit compared to the baseline value was recorded.
Outcome measures
| Measure |
AMG0001
n=7 Participants
Hepatocyte Growth Factor (HGF) Plasmid
HGF Plasmid: Intramuscular injection in the affected limb.
|
|---|---|
|
Change in Hemodynamic Measurement of Baseline Calculated ABI of the Index Leg by Visit
Change from Baseline at Month 3
|
0.286 ratio
Standard Deviation 0.4711
|
|
Change in Hemodynamic Measurement of Baseline Calculated ABI of the Index Leg by Visit
Change from Baseline at Month 6
|
0.115 ratio
Standard Deviation 0.3642
|
|
Change in Hemodynamic Measurement of Baseline Calculated ABI of the Index Leg by Visit
Change from Baseline at Month 9
|
0.102 ratio
Standard Deviation 0.2395
|
|
Change in Hemodynamic Measurement of Baseline Calculated ABI of the Index Leg by Visit
Change from Baseline at Month 12
|
0.254 ratio
Standard Deviation 0.3909
|
|
Change in Hemodynamic Measurement of Baseline Calculated ABI of the Index Leg by Visit
Change from Baseline at Month 15
|
-0.097 ratio
Standard Deviation 0.1815
|
|
Change in Hemodynamic Measurement of Baseline Calculated ABI of the Index Leg by Visit
Change from Baseline at Month 18
|
0.210 ratio
Standard Deviation 0.1709
|
|
Change in Hemodynamic Measurement of Baseline Calculated ABI of the Index Leg by Visit
Change from Baseline at LOCF
|
0.431 ratio
Standard Deviation 0.3365
|
SECONDARY outcome
Timeframe: 18 monthsA summary table including counts and percentages was provided for subjects who had MI, stroke, major amputation, revascularization, or all-cause death for the time periods: 0 to Month 6, 0 to Month 12, 0 to Month 18.
Outcome measures
| Measure |
AMG0001
n=10 Participants
Hepatocyte Growth Factor (HGF) Plasmid
HGF Plasmid: Intramuscular injection in the affected limb.
|
|---|---|
|
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death
Month 0 to 6 · Myocardial infarction
|
0 Participants
|
|
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death
Month 0 to 6 · Stroke
|
0 Participants
|
|
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death
Month 0 to 6 · Major amputation of the index leg
|
1 Participants
|
|
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death
Month 0 to 6 · Revascularization of the index leg
|
1 Participants
|
|
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death
Month 0 to 6 · All-cause death
|
1 Participants
|
|
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death
Month 0 to 6 · No events recorded
|
7 Participants
|
|
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death
Month 0 to 12 · Myocardial infarction
|
0 Participants
|
|
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death
Month 0 to 12 · Stroke
|
0 Participants
|
|
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death
Month 0 to 12 · Major amputation of the index leg
|
2 Participants
|
|
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death
Month 0 to 12 · Revascularization of the index leg
|
1 Participants
|
|
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death
Month 0 to 12 · All-cause death
|
2 Participants
|
|
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death
Month 0 to 12 · No events recorded
|
5 Participants
|
|
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death
Month 0 to 18 · Myocardial infarction
|
0 Participants
|
|
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death
Month 0 to 18 · Stroke
|
0 Participants
|
|
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death
Month 0 to 18 · Major amputation of the index leg
|
2 Participants
|
|
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death
Month 0 to 18 · Revascularization of the index leg
|
3 Participants
|
|
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death
Month 0 to 18 · All-cause death
|
3 Participants
|
|
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death
Month 0 to 18 · No events recorded
|
2 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Number analyzed in one or more rows differs from overall number analyzed due to subject study discontinuation.
A summary table and listing of worsening CLI-related events of the index leg including any new or worsening events, worsening rest pain, new ulcer or worsening ulcer, new or worsening wound infection, peripheral vascular intervention, complication of a peripheral vascular intervention, cellulitis, and amputation due to worsening CLI was provided.
Outcome measures
| Measure |
AMG0001
n=7 Participants
Hepatocyte Growth Factor (HGF) Plasmid
HGF Plasmid: Intramuscular injection in the affected limb.
|
|---|---|
|
Number of Participants With Worsening CLI Event of Index Leg
Month 12 up to 15 : Worsening of ulcer
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
15M to 18M : Any CLI-related events
|
2 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Month 15 up to 18 : Worsening rest pain
|
1 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Month 15 up to 18 : New ulcer
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
15M to 18M : Wound infection (new or worsening)
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Up to 3M : Any CLI-related events
|
3 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Up to 3M : Worsening rest pain
|
3 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Up to 3M : New ulcer
|
2 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Up to 3M : Wound infection (new or worsening)
|
1 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Up to 3M : Amputation due to Worsening CLI
|
1 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Up to 3M : Peripheral vascular intervention
|
1 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Up to 3M : Complication vascular intervention
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Up to 3M : Cellulitis
|
1 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Up to 3M : Worsening of ulcer
|
1 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
3M to 6M : Any CLI-related events
|
2 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
3M to 6M : Worsening rest pain
|
2 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
3M to 6M : New ulcer
|
2 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
3M to 6M : Wound infection (new or worsening)
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
3M to 6M : Amputation due to Worsening CLI
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
3M to 6M : Peripheral vascular intervention
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
3M to 6M : Complication of vascular intervention
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
3M to 6M : Cellulitis
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
3M to 6M : Worsening of ulcer
|
1 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
6M to 9M : Any CLI-related events
|
2 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
6M to 9M : Worsening rest pain
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
6M to 9M : New ulcer
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
6M to 9M : Wound infection (new or worsening)
|
1 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Month 6 up to 9 : Amputation due to Worsening CLI
|
2 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Month 6 up to 9 : Peripheral vascular intervention
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
6M to 9M : Complication of vascular intervention
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Month 6 up to 9 : Cellulitis
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Month 6 up to 9 : Worsening of ulcer
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
9M to 12M : Any CLI-related events
|
1 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Month 9 up to 12 : Worsening rest pain
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Month 9 up to 12 : New ulcer
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
9M to 12M : Wound infection (new or worsening)
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Month 9 up to 12 : Amputation due to Worsening CLI
|
1 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
9M to 12M : Peripheral vascular intervention
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
9M to 12M : Complication of vascular intervention
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Month 9 up to 12 : Cellulitis
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Month 9 up to 12 : Worsening of ulcer
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
12M to 15M : Any CLI-related events
|
2 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Month 12 up to 15 : Worsening rest pain
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Month 12 up to 15 : New ulcer
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
12M to 15M : Wound infection (new or worsening)
|
1 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
12M to 15M : Amputation due to Worsening CLI
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
12M to 15M : Peripheral vascular intervention
|
1 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
12M to 15M : Complication of vascular intervention
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Month 12 up to 15 : Cellulitis
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
15M to 18M : Amputation due to Worsening CLI
|
1 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
15M to 18M : Peripheral vascular intervention
|
1 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
15M to 18M : Complication of vascular intervention
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Month 15 up to 18 : Cellulitis
|
0 Participants
|
|
Number of Participants With Worsening CLI Event of Index Leg
Month 15 up to 18 : Worsening of ulcer
|
0 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Number analyzed in one or more rows differs from overall number analyzed due to subject study discontinuation.
Shift from baseline in Rutherford classification was summarized by study visit. Patients enrolled in the study were classified as either Rutherford 4 or Rutherford 5 at baseline. Rutherford category (clinical description) 0 (Asymptomatic - no hemodynamically significant occlusive disease) 1. (Mild claudication) 2. (Moderate claudication) 3. (Severe claudication) 4. (Ischemic rest pain) 5. (Minor tissue loss - nonhealing ulcer, focal gangrene with diffuse pedal ischemia) 6. (Major tissue loss - extending above TM level, functional foot no longer salvageable)
Outcome measures
| Measure |
AMG0001
n=5 Participants
Hepatocyte Growth Factor (HGF) Plasmid
HGF Plasmid: Intramuscular injection in the affected limb.
|
|---|---|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Up to Month 3 (Baseline R4) · Shift to R2
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 6 to 9 (Baseline R4) · Shift to R1
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 6 to 9 (Baseline R4) · Shift to R2
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 6 to 9 (Baseline R4) · Shift to R3
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 6 to 9 (Baseline R4) · Shift to R4
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 6 to 9 (Baseline R4) · Shift to R5
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 6 to 9 (Baseline R4) · Shift to R6
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 6 to 9 (Baseline R4) · Discontinuation due to Death, AE or CLI Event
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 9 to 12 (Baseline R4) · Shift to R1
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 9 to 12 (Baseline R4) · Shift to R2
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 9 to 12 (Baseline R4) · Shift to R3
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 9 to 12 (Baseline R4) · Shift to R4
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 9 to 12 (Baseline R4) · Shift to R5
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 9 to 12 (Baseline R4) · Shift to R6
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 9 to 12 (Baseline R4) · Discontinuation due to Death, AE or CLI Event
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 12 to 15 (Baseline R4) · Shift to R1
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 12 to 15 (Baseline R4) · Shift to R2
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 12 to 15 (Baseline R4) · Shift to R3
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 12 to 15 (Baseline R4) · Shift to R4
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 12 to 15 (Baseline R4) · Shift to R5
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 12 to 15 (Baseline R4) · Shift to R6
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 12 to 15 (Baseline R4) · Discontinuation due to Death, AE or CLI Event
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 15 to 18 (Baseline R4) · Shift to R1
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 15 to 18 (Baseline R4) · Shift to R2
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 15 to 18 (Baseline R4) · Shift to R3
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 15 to 18 (Baseline R4) · Shift to R4
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 15 to 18 (Baseline R4) · Shift to R5
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 15 to 18 (Baseline R4) · Shift to R6
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 15 to 18 (Baseline R4) · Discontinuation due to Death, AE or CLI Event
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Up to Month 3 (Baseline R5) · Shift to R1
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Up to Month 3 (Baseline R5) · Shift to R2
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Up to Month 3 (Baseline R5) · Shift to R3
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Up to Month 3 (Baseline R5) · Shift to R4
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Up to Month 3 (Baseline R5) · Shift to R5
|
3 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Up to Month 3 (Baseline R5) · Shift to R6
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Up to Month 3 (Baseline R5) · Discontinuation due to Death, AE or CLI Event
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 3 to 6 (Baseline R5) · Shift to R1
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 3 to 6 (Baseline R5) · Shift to R2
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 3 to 6 (Baseline R5) · Shift to R3
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 3 to 6 (Baseline R5) · Shift to R4
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 3 to 6 (Baseline R5) · Shift to R5
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 3 to 6 (Baseline R5) · Shift to R6
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 3 to 6 (Baseline R5) · Discontinuation due to Death, AE or CLI Event
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 6 to 9 (Baseline R5) · Shift to R1
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 6 to 9 (Baseline R5) · Shift to R2
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 6 to 9 (Baseline R5) · Shift to R3
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 6 to 9 (Baseline R5) · Shift to R4
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 6 to 9 (Baseline R5) · Shift to R5
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 6 to 9 (Baseline R5) · Shift to R6
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 6 to 9 (Baseline R5) · Discontinuation due to Death, AE or CLI Event
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 9 to 12 (Baseline R5) · Shift to R1
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 9 to 12 (Baseline R5) · Shift to R2
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 9 to 12 (Baseline R5) · Shift to R3
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 9 to 12 (Baseline R5) · Shift to R4
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 9 to 12 (Baseline R5) · Shift to R5
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 9 to 12 (Baseline R5) · Shift to R6
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 9 to 12 (Baseline R5) · Discontinuation due to Death, AE or CLI Event
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 12 to 15 (Baseline R5) · Shift to R1
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 12 to 15 (Baseline R5) · Shift to R2
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 12 to 15 (Baseline R5) · Shift to R3
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 12 to 15 (Baseline R5) · Shift to R4
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 12 to 15 (Baseline R5) · Shift to R5
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 12 to 15 (Baseline R5) · Shift to R6
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 12 to 15 (Baseline R5) · Discontinuation due to Death, AE or CLI Event
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 15 to 18 (Baseline R5) · Shift to R1
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 15 to 18 (Baseline R5) · Shift to R2
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 15 to 18 (Baseline R5) · Shift to R3
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 15 to 18 (Baseline R5) · Shift to R4
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 15 to 18 (Baseline R5) · Shift to R5
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 15 to 18 (Baseline R5) · Shift to R6
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 15 to 18 (Baseline R5) · Discontinuation due to Death, AE or CLI Event
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Up to Month 3 (Baseline R4) · Shift to R1
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Up to Month 3 (Baseline R4) · Shift to R3
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Up to Month 3 (Baseline R4) · Shift to R4
|
4 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Up to Month 3 (Baseline R4) · Shift to R5
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Up to Month 3 (Baseline R4) · Shift to R6
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Up to Month 3 (Baseline R4) · Discontinuation due to Death, AE or CLI Event
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 3 to 6 (Baseline R4) · Shift to R1
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 3 to 6 (Baseline R4) · Shift to R2
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 3 to 6 (Baseline R4) · Shift to R3
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 3 to 6 (Baseline R4) · Shift to R4
|
2 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 3 to 6 (Baseline R4) · Shift to R5
|
1 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 3 to 6 (Baseline R4) · Shift to R6
|
0 Participants
|
|
Number of Participants With Shift From Baseline in Rutherford Classification
Month 3 to 6 (Baseline R4) · Discontinuation due to Death, AE or CLI Event
|
0 Participants
|
Adverse Events
AMG0001
Serious events: 7 serious events
Other events: 10 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
AMG0001
n=10 participants at risk
Hepatocyte Growth Factor (HGF) Plasmid
HGF Plasmid: Intramuscular injection in the affected limb.
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Cardiac disorders
Cardiac failure
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Cardiac disorders
Cardiac failure congestive
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Gastrointestinal disorders
Colitis
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Gastrointestinal disorders
Intestinal ischemia
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Infections and infestations
Pneumonia
|
20.0%
2/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Injury, poisoning and procedural complications
Post procedural hematoma
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Nervous system disorders
Carotid artery stenosis
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Nervous system disorders
Diabetic neuropathy
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Renal and urinary disorders
Renal failure acute
|
20.0%
2/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Surgical and medical procedures
Leg amputation
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Surgical and medical procedures
Toe amputation
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Vascular disorders
Ischemic limb pain
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Vascular disorders
Peripheral ischemia
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyosarcoma
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
Other adverse events
| Measure |
AMG0001
n=10 participants at risk
Hepatocyte Growth Factor (HGF) Plasmid
HGF Plasmid: Intramuscular injection in the affected limb.
|
|---|---|
|
General disorders
Administration site reaction
|
90.0%
9/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
General disorders
Injection site discharge
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
General disorders
Oversensing
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Injury, poisoning and procedural complications
Excoriation
|
40.0%
4/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Injury, poisoning and procedural complications
Contusion
|
30.0%
3/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Injury, poisoning and procedural complications
Laceration
|
20.0%
2/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Injury, poisoning and procedural complications
Anemia postoperative
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Injury, poisoning and procedural complications
Limb injury
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Injury, poisoning and procedural complications
Skin wound
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Infections and infestations
Pneumonia
|
20.0%
2/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Infections and infestations
Urinary tract infection
|
20.0%
2/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Infections and infestations
Pseudomonas infection
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Infections and infestations
Wound infection
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Cardiac disorders
Cardiac failure
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Cardiac disorders
Atrial flutter
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Cardiac disorders
Cardiac failure acute
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Cardiac disorders
Ventricular tachycardia
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Gastrointestinal disorders
Duodenal ulcer
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
2/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Skin and subcutaneous tissue disorders
Blister
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Investigations
Blood glucose increased
|
20.0%
2/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Investigations
Oxygen saturation decreased
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Nervous system disorders
Myoclonus
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Psychiatric disorders
Delirium
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Blood and lymphatic system disorders
anaemia
|
20.0%
2/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Eye disorders
Diabetic retinopathy
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Eye disorders
Macular oedema
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Eye disorders
Vitreous adhesions
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Metabolism and nutrition disorders
hypomagnesaemia
|
20.0%
2/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Renal and urinary disorders
Renal failure chronic
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place