Trial Outcomes & Findings for Systemic and Local Diffusion of Ethanol After Administration of Ethanol 96% Formulated in a Gel and Ethanol 98% Solution by the Percutaneous Route, in Patients With Congenital Venous Malformations:Pharmacokinetic, Pharmacodynamic and Clinical Study. (NCT NCT00462462)
NCT ID: NCT00462462
Last Updated: 2015-01-15
Results Overview
Blood samples were performed, just before infusion, then 5 min, 10 min, 20 min, 40 min, 60 min, 90 min, and 120 min after infusion at the first site, then every 60 min onwards until ethanol levels are found under the detection limit. Cmax was estimated directly from experimental data. If all the ethanol concentrations of a patient was below the limit of quantification of the laboratory (LOQ), Cmax was reported as LOQ/2 for this patient.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Baseline visit (just before and during test product infusion procedure)
Results posted on
2015-01-15
Participant Flow
32 patients were enrolled in the study, but 31 received the study product (1 patient not treated; inclusion mistake).
Participant milestones
| Measure |
L0122 Gel Group
Patients who received one intralesional administration of L0122 gel
|
Absolute Ethanol Group
Patients who received one intralesional administration of Absolute Ethanol
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
14
|
|
Overall Study
COMPLETED
|
17
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
L0122 Gel Group
Patients who received one intralesional administration of L0122 gel
|
Absolute Ethanol Group
Patients who received one intralesional administration of Absolute Ethanol
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Systemic and Local Diffusion of Ethanol After Administration of Ethanol 96% Formulated in a Gel and Ethanol 98% Solution by the Percutaneous Route, in Patients With Congenital Venous Malformations:Pharmacokinetic, Pharmacodynamic and Clinical Study.
Baseline characteristics by cohort
| Measure |
L0122 Gel Group
n=17 Participants
Patients who received one intralesional administration of L0122 gel
|
Absolute Ethanol Group
n=14 Participants
Patients who received one intralesional administration of Absolute Ethanol
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Lesional volume
|
82.712 cm3
STANDARD_DEVIATION 156.316 • n=5 Participants
|
561.472 cm3
STANDARD_DEVIATION 1147.306 • n=7 Participants
|
298.926 cm3
STANDARD_DEVIATION 801.306 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline visit (just before and during test product infusion procedure)Blood samples were performed, just before infusion, then 5 min, 10 min, 20 min, 40 min, 60 min, 90 min, and 120 min after infusion at the first site, then every 60 min onwards until ethanol levels are found under the detection limit. Cmax was estimated directly from experimental data. If all the ethanol concentrations of a patient was below the limit of quantification of the laboratory (LOQ), Cmax was reported as LOQ/2 for this patient.
Outcome measures
| Measure |
L0122 Gel Group
n=17 Participants
Patients who received one intralesional administration of L0122 gel and who had blood samples just before and during infusion procedure.
|
Absolute Ethanol Group
n=13 Participants
Patients who received one intralesional administration of Absolute Ethanol and who had blood samples just before and during infusion procedure (one patient who received Absolute Ethanol was not sampled during infusion procedure).
|
|---|---|---|
|
Systemic Exposure to Ethanol With the Two Test Products: Determination of the Maximum Plasma Concentration (Cmax)
|
0.0604 g/L
Interval 0.015 to 0.4
|
0.202 g/L
Interval 0.05 to 0.94
|
SECONDARY outcome
Timeframe: Study endOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening and study end (Day 112)Outcome measures
| Measure |
L0122 Gel Group
n=17 Participants
Patients who received one intralesional administration of L0122 gel and who had blood samples just before and during infusion procedure.
|
Absolute Ethanol Group
n=13 Participants
Patients who received one intralesional administration of Absolute Ethanol and who had blood samples just before and during infusion procedure (one patient who received Absolute Ethanol was not sampled during infusion procedure).
|
|---|---|---|
|
Change in Volume of Congenital Venous Malformation (CVM) From Screening to Study End (Day 112 Visit).
|
-10.328 cm3
Standard Deviation 36.667
|
-126.944 cm3
Standard Deviation 367.229
|
SECONDARY outcome
Timeframe: study endOutcome measures
Outcome data not reported
Adverse Events
L0122 Gel Group
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Absolute Ethanol Group
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
L0122 Gel Group
n=17 participants at risk
Patients who received one intralesional administration of L0122 gel
|
Absolute Ethanol Group
n=14 participants at risk
Patients who received one intralesional administration of Absolute Ethanol
|
|---|---|---|
|
Investigations
Blood ethanol increased
|
0.00%
0/17
|
21.4%
3/14
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
11.8%
2/17
|
7.1%
1/14
|
Other adverse events
| Measure |
L0122 Gel Group
n=17 participants at risk
Patients who received one intralesional administration of L0122 gel
|
Absolute Ethanol Group
n=14 participants at risk
Patients who received one intralesional administration of Absolute Ethanol
|
|---|---|---|
|
General disorders
Injection site paraesthesia
|
17.6%
3/17
|
0.00%
0/14
|
|
General disorders
Pain
|
5.9%
1/17
|
7.1%
1/14
|
|
General disorders
Chest pain
|
5.9%
1/17
|
0.00%
0/14
|
|
General disorders
Injection site discolouration
|
5.9%
1/17
|
0.00%
0/14
|
|
General disorders
Injection site extravasation
|
5.9%
1/17
|
0.00%
0/14
|
|
General disorders
Injection site thrombosis
|
5.9%
1/17
|
0.00%
0/14
|
|
General disorders
Complication of device insertion
|
0.00%
0/17
|
7.1%
1/14
|
|
General disorders
Injection site haematoma
|
0.00%
0/17
|
7.1%
1/14
|
|
General disorders
Injection site pain
|
0.00%
0/17
|
7.1%
1/14
|
|
General disorders
Injection site ulcer
|
0.00%
0/17
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
11.8%
2/17
|
28.6%
4/14
|
|
Injury, poisoning and procedural complications
Delayed recovery from anaesthesia
|
5.9%
1/17
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
5.9%
1/17
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Airway complication of anaesthesia
|
0.00%
0/17
|
7.1%
1/14
|
|
Blood and lymphatic system disorders
Haemolysis
|
11.8%
2/17
|
28.6%
4/14
|
|
Blood and lymphatic system disorders
Coagulopathy
|
5.9%
1/17
|
35.7%
5/14
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.00%
0/17
|
7.1%
1/14
|
|
Investigations
Fibrin degradation products increased
|
5.9%
1/17
|
7.1%
1/14
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/17
|
7.1%
1/14
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.9%
1/17
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.9%
1/17
|
0.00%
0/14
|
|
Vascular disorders
Deep vein thrombosis
|
5.9%
1/17
|
0.00%
0/14
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/17
|
7.1%
1/14
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17
|
7.1%
1/14
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/17
|
7.1%
1/14
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17
|
7.1%
1/14
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/17
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/17
|
7.1%
1/14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60