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.
Absolute ethanol has been used "off-label" as an unmodified formulation (solution) in Congenital Venous Malformations (CVM). Despite its effectiveness, absolute ethanol appears difficult to handle because of its high diffusion capacity outside the CVM and in the blood circulation. A less diffusible ethanol-based product (ethanol gel) has been developed in order to minimize systemic and local diffusion capacities of ethanol. Therefore, the pharmacokinetic parameters and their clinical and paraclinical outcomes between ethanol gel 96% and absolute ethanol need to be carried out.
FDA Office of Orphan Products Development (FDA OOPD) : Funding source.
Congenital Venous Malformation
Drug: Ethanol 96% Gel
Drug: Ethanol 98% Solution
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||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.|
- Systemic Exposure to Ethanol With the Two Test Products: Determination of the Maximum Plasma Concentration (Cmax) [ Time Frame: Baseline visit (just before and during test product infusion procedure) ] [ Designated as safety issue: Yes ]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.
- Systemic (Cardiopulmonary, Hematological, Metabolic) and Local Outcome of the Two Test Products. [ Time Frame: Study end ] [ Designated as safety issue: Yes ]
- Change in Volume of Congenital Venous Malformation (CVM) From Screening to Study End (Day 112 Visit). [ Time Frame: Screening and study end (Day 112) ] [ Designated as safety issue: No ]
- Patient Benefit [ Time Frame: study end ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
|Drug: Ethanol 96% Gel|
Active Comparator: 2
|Drug: Ethanol 98% Solution|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462462
|United States, Maryland|
|Johns Hopkins Medical Institutions|
|Baltimore, Maryland, United States, 21287|
|Hôpital Bretonneau Service de neuroradiologie|
|Tours Cedex 1, France, 37044|
|Study Director:||PATRICK DUPUY, MD||ORFAGEN LABORATORIES (France)|
|Principal Investigator:||SALLY E MITCHELL, MD||Johns Hopkins Medical Institution (Baltimore, USA)|
|Principal Investigator:||Denis HERBRETEAU, MD||Hôpital Bretonneau (Tours, France)|