280. 巨大動静脈奇形(頚部顔面又は四肢病変) Huge arteriovenous malformation with cervicofacial or limb lesion Clinical trials / Disease details


臨床試験数 : 25 薬物数 : 29 - (DrugBank : 15) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 153

  
4 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-001530-33-FR
(EUCTR)
29/06/201901/04/2019TOPical sirolimus in linGUal microkystic lymphatic malformation-TOPGUNTOPical sirolimus in linGUal microkystic lymphatic malformation-TOPGUN - TOPGUN Lingual microcystic lymphatic malformations (LMLM) in children and adults
MedDRA version: 20.0;Level: LLT;Classification code 10003229;Term: Arteriovenous malformations;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: RAPAMUNE
Product Name: Sirolimus 1mg/mL
Product Code: L04AA10
CHRU TOURSNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
12 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance
2EUCTR2018-001359-11-FR
(EUCTR)
22/02/201923/07/20180.1% topical sirolimus in the treatment of cutaneous microcystic lymphatic malformations in children and adults: phase II, split-body randomized, double-blind, vehicle-controlled clinical trial0.1% topical sirolimus in the treatment of cutaneous microcystic lymphatic malformations in children and adults: phase II, split-body randomized, double-blind, vehicle-controlled clinical trial - TOPICAL Cutaneous microcystic lymphatic malformations (CMLM) in children and adults
MedDRA version: 20.0;Level: LLT;Classification code 10003229;Term: Arteriovenous malformations;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Sirolimus 0,1% crème
INN or Proposed INN: SIROLIMUS
CHRU TOURSNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
55 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance
3JPRN-UMIN000030522
2017/11/1422/12/2017A multicenter, single-arm, prospective study assessing efficacy and safety of the Sirolimus in the Treatment of intractable vascular anomalies Intractable vascular anomalies: Cystic lymphatic malformation, Lymphangiomatosis (Generalized lymphatic anomaly, Kaposiform lymphangiomatosis), Gorham-Stout disease, Kaposiform hemangioendothelioma and Tuffted angioma with Kasabach-Merritt phenomenon, Nenous malformation, Arteriovenous malformation, Klippel-Trenaunay-Weber syndrome,Bluerubber bleb nevus syndrome, Complex-combined vascular malformationsBody surface area (BSA) >= 1.0m2: an initial dose of sirolimus (2mg/day) is single orally administered under fed or fasting condition. Subsequently, the sirolimus dosage is adjusted to achieve trough levels between 5-15 ng/mL. Maximum dose of sirolimus is 4 mg per day.
BSA < 1.0m2: an initial dose of sirolimus (1mg/day) is single orally administered under fed or fasting condition. Subsequently, the sirolimus dosage is adjusted to achieve trough levels between 5-15 ng/mL. Maximum dose of sirolimus is 4 mg per day.
Gifu UniversityNULLRecruitingNot applicableNot applicableMale and Female50Not selectedJapan
4NCT02042326
(ClinicalTrials.gov)
September 12, 201420/1/2014Prospective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous MalformationsProspective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous MalformationsArteriovenous MalformationsDrug: SirolimusCentre Hospitalier Universitaire, AmiensNULLRecruiting2 YearsN/AAll50Phase 2Belgium;France