279. 巨大静脈奇形(頚部口腔咽頭びまん性病変) Huge venous malformation with cervical, oral and pharyngeal diffuse lesion Clinical trials / Disease details


臨床試験数 : 15 薬物数 : 24 - (DrugBank : 10) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 105

  
No.TrialIDDate_
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PhaseCountries
1ChiCTR2100053242
2022-06-122021-11-17Clinical study on the safety and efficacy of fibrin glue combined with local injection of pingyangmycin in the treatment of head and neck venous malformationsA prospective, open-label, single-arm, phase II clinical trial to evaluate the efficacy of pingyangmycin combined with fibrin glue in the treatment of head and neck venous malformations Head and Neck Venous MalformationExperimental group:Pingyangmycin combined with local injection of fibrin glue;The First Affiliated Hospital of Sun Yat-Sen UniversityNULLRecruiting170BothExperimental group:20;Phase 2China
2NCT04861064
(ClinicalTrials.gov)
January 18, 202223/4/2021Weekly Sirolimus TherapyWeekly Sirolimus Therapy for the Treatment of Venous and Lymphatic MalformationsVenous Malformation;Lymphatic MalformationDrug: SirolimusMedical University of South CarolinaNULLRecruiting2 YearsN/AAll24Phase 2United States
3ChiCTR2100052762
2021-11-012021-11-05Efficacy and safety of topical sirolimus and laser in the treatment of verrucous venous malformationsEfficacy and safety of topical sirolimus and laser in the treatment of verrucous venous malformations Verrucous Venous Malformationgroup 1:topical sirolimus ;group 2:laser ;Shanghai Ninth People's HospitalNULLPending065Bothgroup 1:25;group 2:25;China
4JPRN-jRCT2051200046
15/01/202125/08/2020A study for evaluation of efficacy and safety of ethanolamine oleate in patients with venous malformationsEvaluation of efficacy and safety of ethanolamine oleate in sclerotherapy in patients with venous malformations: A multicenter, open-label, single-arm study - EO-1 Venous malformation difficult to removeInjection of 5% ethanolamine oleate which is double diluted by contrast or normal saline for the venous malformation, within maximum dosage of 0.4 mL/kg. Same method of administration is performed for children. Maximum volume of the drug in once treatment is 30 mL after preparation.Nomura TadashiNomura Tadashi;Ozaki MineRecruitingNot applicableNot applicableBoth44Phase 3Japan
5JPRN-jRCTs061200036
11/12/202011/12/2020Prospective trial to verify the efficacy and safety of sclerotherapy with polidocanol for painful venous malformationsA single-center, one-arm, prospective, openlabel trial to verify the efficacy and safety of sclerotherapy with polidocanol for painful venous malformations - SCIRO-2001 Painful venous malformationsSclerotherapy with polidocanolUka MayuNULLRecruiting>= 12age oldNot applicableBoth13N/AJapan
6NCT04258046
(ClinicalTrials.gov)
March 31, 202016/1/2020Trametinib in the Treatment of Complicated Extracranial Arterial Venous MalformationPhase II Clinical Trial of MEK Inhibitor Trametinib in the Treatment of Complicated Extracranial Arterial Venous Malformation (VM)Venous Malformation;Arterial DiseaseDrug: Trametinib tabletStanford UniversityBoston Children's HospitalNot yet recruiting12 Years60 YearsAll30Phase 2United States
7NCT04930952
(ClinicalTrials.gov)
February 28, 201911/6/2021Complications of Ethanol-amine Oleate Intralesional SclerotherapyComplications of Ethanol-amine Oleate Intralesional Sclerotherapy Injections of Maxillofacial Venous Malformations in Pediatric PatientsVenous MalformationDrug: Ethanol-amine Oleate Sclerotherapy InjectionSuez Canal UniversityNULLCompletedN/A12 YearsAll15Egypt
8NCT03767660
(ClinicalTrials.gov)
July 31, 201824/11/2018Efficacy of Rapamycin (Sirolimus) in the Treatment of BRBNS, Hereditary or Sporadic Venous MalformationEfficacy of Rapamycin (Sirolimus) in the Treatment of Blue Rubber Bleb Nevus Syndrome, Hereditary or Sporadic Venous MalformationBlue Rubber Bleb Nevus Syndrome;Venous MalformationDrug: RapamycinPeking Union Medical College HospitalAir Force General Hospital of the PLA;Chinese Academy of Medical SciencesRecruitingN/AN/AAll20Phase 4China
9ChiCTR-OIB-15007455
2015-03-182015-11-24Effect of sclerotherapy on venous malformation associated with localized intravascular coagulopathy: A prospective, before-after controlled studyEffect of sclerotherapy on venous malformation associated with localized intravascular coagulopathy: A prospective, before-after controlled study venous malformation1:sclerotherapy with ethanol;Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of MedicineNULLRecruitingBoth1:40;I (Phase 1 study)China
10EUCTR2011-001455-37-NO
(EUCTR)
21/12/201101/06/2011Prospective randomized interventional study in patients with venous malformations.Prospective randomized interventional study. Compare the effect of bleomycin and Tetradecyl Sodium Sulphate (Fibrovein) in the treatment of venous malformations. Clinical neurological and neurophysiological study of a subpopulation of patients with venous malformations. Venous malformation
MedDRA version: 13.1;Level: LLT;Classification code 10047229;Term: Venous malformation NOS;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Bleomycin Baxter
Product Name: Bleomycin
Trade Name: Fibrovein 3%
Product Name: Fibrovein 3%
Department of Radiology, Oslo University Hospital, NorwayNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Norway
11NCT01347294
(ClinicalTrials.gov)
August 201111/4/2011Compare Two Different Sclerosing Agents in the Treatment of Venous MalformationsCompare the Effect of Bleomycin and Tetradecyl Sodium Sulphate in the Treatment of Venous MalformationsVenous MalformationDrug: Bleomycin;Drug: Fibrovein;Drug: Bleomycin + FibroveinOslo University HospitalNULLRecruiting12 Years80 YearsAll126Phase 4Norway
12JPRN-jRCTs071180067
23/10/200920/03/2019Clinical research of intralesional sclerotherapy in the oral and maxillofacial regionClinical research for safty and efficacy in intralesional sclerotherapy with ethanolamine oleate for subcutaneous venous malformation in the oral and maxillofacial region - EOST-OMS Venous malformation in the oral and maxillofacial region
Sclerotherapy, Venous malformation, ethanolamine oleate;angioma, venous
Single arm study, open (masking not used), no assignment
All procedures will be done with oral surgeon and radiologist in angiography room. (For superficial lesion, procedures will be done with intermittent simple X-ray for reduction of exposure, despite using angiography to confirm drainage veins in oral and maxillofacial outpatient clinic.)
1. Local anesthesia into the lesion.
2. Puncture with 22-24G needle and confirm the backflow of blood.
3. Stabilize the needle and check the distribution and blood flow of the lesion by angiography and computed tomography (CT) with contrast medium. If there is any risk that sclerosing agent will escape whole body, we must decide the cancellation of the trial. If we can block the drainage vein over 5 minutes, we decide that the trial can continue. (For superficial lesions, we inject contrast medium in oral and maxillofacial outpatient clinic and confirm retention of contrast medium using intermittent simple X-ray.)
4. Treat with injection 5% ethanolamine oleate(EO) (diluted by Iopamiron 300) . Volume of the 5%EO will be decided by situation, but the maximum volume is 20ml (5% EO) by one treatment. After 5 minites, the 5%EO collect as possible.
5. Check the hemostasis of the injection point(s).
Danjo AtsushiNULLRecruitingNot applicableNot applicableBoth25Phase 2Japan
13NCT00975819
(ClinicalTrials.gov)
October 200910/9/2009Safety and Efficacy Study of Sirolimus in Complicated Vascular AnomaliesA Phase 2 Study - Clinical Trial Assessing Efficacy and Safety of the mTOR Inhibitor Sirolimus in the Treatment of Complicated Vascular AnomaliesKaposiform Hemangioendotheliomas;Tufted Angioma;Capillary Venous Lymphatic Malformation;Venous Lymphatic Malformation;Microcystic Lymphatic Malformation;Mucocutaneous Lymphangiomatosis and Thrombocytopenia;Capillary Lymphatic Arterial Venous Malformations;PTEN Overgrowth Syndrome With Vascular Anomaly;Lymphangiectasia SyndromesDrug: sirolimusChildren's Hospital Medical Center, CincinnatiNULLActive, not recruitingN/A31 YearsBoth60Phase 2United States
14EUCTR2009-011276-29-FR
(EUCTR)
21/08/200915/05/2009Systemic 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.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. patients with congenital venous malformations (CVM)Product Name: Ethanol gel
Product Code: L0122
Other descriptive name: ETHANOL (96 PER CENT)
Trade Name: Dehydrated Alcohol (Absolute Alcohol) BP for Injection
Product Name: Dehydrated Alcohol (Absolute Alcohol) BP for Injection
Other descriptive name: ETHANOL BP
ORFAGENNULLNot RecruitingFemale: yes
Male: yes
24Phase 2France
15NCT00462462
(ClinicalTrials.gov)
May 200716/4/2007Systemic 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 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.Congenital Venous MalformationDrug: Ethanol 96% Gel;Drug: Ethanol 98% SolutionOrfagenFDA Office of Orphan Products DevelopmentCompleted12 YearsN/AAll32Phase 2United States;France