Systemic and local diffusion of ethanol after administration of ethanol 96% formulated in a gel (L0122 Gel) and ethanol 98% solution (absolute ethanol) by the percutaneous route, in patients with congenital venous malformations (CVM): pharmacokinetic, pharmacodynamic and clinical study.

• Register: EUCTR
• Last refreshed on: 4 April 2022
• Main ID: EUCTR2009-011276-29-FR
• Date of registration: 15/05/2009
• Prospective Registration: Yes
• Primary sponsor: ORFAGEN
• Public title: Systemic and local diffusion of ethanol after administration of ethanol 96% formulated in a gel (L0122 Gel) and ethanol 98% solution (absolute ethanol) by the percutaneous route, in patients with congenital venous malformations (CVM): pharmacokinetic, pharmacodynamic and clinical study.
• Scientific title: Systemic and local diffusion of ethanol after administration of ethanol 96% formulated in a gel (L0122 Gel) and ethanol 98% solution (absolute ethanol) by the percutaneous route, in patients with congenital venous malformations (CVM): pharmacokinetic, pharmacodynamic and clinical study.
• Date of first enrolment: 21/08/2009
• Target sample size: 24
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011276-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion criteria:
-Patients of both sexes, of at least 12 years of age,
-For women of childbearing potential, negative pregnancy test at baseline,
-Patients with one clinically and radiologically (MRI) documented lesion diagnosed as CVM (pure or predominant),
-Patients for which an embolosclerotherapy by the percutaneous route is indicated as first line therapy of the test lesion, or for which previous treatments (i.e. surgery, embolosclerotherapy, laser) have been unsuccessful or insufficient,
-Patients with CVM lesional size of at least 12 cm3 (maximum craniocaudal dimension X mean dimension of 3 transverse equispaced measurements X mean dimension of 3 deepness equispaced measurements dimension) at MRI,
-Patients with focal or multifocal CVM lesion, i.e. with one or several well-interconnecting venous spaces and well-defined margins,
-Patients or parents able to follow study instructions and attend study visits,
-Written informed consent from the patients or parents.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
-Patients under 12 years of age,
-Pregnant women, nursing mothers and women of childbearing potential with no reliable contraception from more than 2 months,
-Women of childbearing potential with a positive pregnancy test at baseline,
-Patients with CVM of non venous predominance,
-Patients with CVM that are not reachable by the percutaneous route,
-Patients with extensive superficial skin CVM (i.e. with high risk of skin necrosis),
-Patients with a test lesion adjacent to major nerves (e.g. facial nerve in the parotid region, intramuscular regions adjacent to major nerves),
-Patients with facial CVM or bone involvement,
-Patients with small CVM lesion (<12 cm3 at MRI),
-Patients requiring more than 1 ml/Kg body weight (b.w.) in USA or more than 0.5 ml/Kg b.w. in france, or more than 30 mL of absolute ethanol to infuse,
-Patients with a known allergy to one of the components of the test products,
-Patients with a suspected allergy to iodinated products,
-Patients with abnormal clotting parameters (platelets, partial thromboplastin, prothrombin time),
-Patients with an active inflammatory episode of the test lesion (i.e. acute or subacute swelling of the test lesion),
-Patients with complex malformations (e.g. Klippel-Trenaunay syndrome, Blue Rubber Bled Nevus syndrome, Muco-cutaneous familial venous malformations, Mafucci’s syndrome),
-Patients in which a surgery, laser therapy or embolosclerotherapy of the test lesion has been performed within the last 12 weeks prior to study entry,
-Asthmatic patients who require daily medications,
-Patients with a non treated or non stabilized cardiac disease,
-Patients with a suspected right-left shunt,
-Patients with an intercurrent condition or a concomitant treatment which may interfere with a good conduct or the evaluation parameters of the study,
-Patients who participated in a study within the 12 weeks prior to study entry,
-Patients or parents who are not able or willing to follow the study instructions,
-Patients or parents who refuse to give written informed consent.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

patients with congenital venous malformations (CVM)

Intervention(s)

Product Name: Ethanol gel
Product Code: L0122
Pharmaceutical Form: Gel for injection
CAS Number: 64-17-5
Other descriptive name: ETHANOL (96 PER CENT)
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 94.12-

Trade Name: Dehydrated Alcohol (Absolute Alcohol) BP for Injection
Product Name: Dehydrated Alcohol (Absolute Alcohol) BP for Injection
Pharmaceutical Form: Solution for injection
CAS Number: 64-17-5
Other descriptive name: ETHANOL BP
Concentration unit: % (V/V) percent volume/volume
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Main Objective: To compare the systemic exposure to ethanol with the two test products.

Primary end point(s): Pharmacokinetic parameter (primary study parameter): Cmax
The parameter will be determined by plasma monitoring of ethanol just before infusion, then 5 mn, 10 mn, 20 mn, 40 mn, 60 mn, 90 mn, 120 mn after infusion at the first site, and every 60 mn onwards until ethanolemia becomes undetectable.

Secondary Objective: - To compare the systemic (cardiopulmonary, hematological, metabolic) and local outcome of the two test products.
- To compare the embolosclerosing activity of L0122 gel and absolute ethanol on size reduction of CVM.
- To compare the clinical efficacy (patient benefit) of the two test products.

Secondary ID(s)

L00122 GI 201 (ORF)

Ethics review

Status: Approved
Approval date: 21/08/2009
Contact:

Results

• Results available: Yes
• Date Posted: 11/08/2016
• Date Completed: 30/06/2010
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-011276-29/results