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
| No. | TrialID | Date_ enrollment  | Date_ registration  | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor  | Secondary_ sponsor  | Recruitment_ Status  | Inclusion_ agemin  | Inclusion_ agemax  | Inclusion_ gender  | Target_ size  | Phase | Countries | 
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-001530-33-FR (EUCTR)  | 29/06/2019 | 01/04/2019 | TOPical sirolimus in linGUal microkystic lymphatic malformation-TOPGUN | TOPical 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 TOURS | NULL | Authorised-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): no | France | ||
| 2 | EUCTR2018-001359-11-FR (EUCTR)  | 22/02/2019 | 23/07/2018 | 0.1% 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 | 0.1% 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 TOURS | NULL | Authorised-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): no | France | ||
| 3 | JPRN-UMIN000030522 | 2017/11/14 | 22/12/2017 | A 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 malformations | Body 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 University | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 50 | Not selected | Japan | |
| 4 | NCT02042326 (ClinicalTrials.gov)  | September 12, 2014 | 20/1/2014 | Prospective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous Malformations | Prospective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous Malformations | Arteriovenous Malformations | Drug: Sirolimus | Centre Hospitalier Universitaire, Amiens | NULL | Recruiting | 2 Years | N/A | All | 50 | Phase 2 | Belgium;France |