278. 巨大リンパ管奇形（頚部顔面病変） Huge lymphatic malformation with cervicofacial lesion Clinical trials / Disease details
臨床試験数 : 19 / 薬物数 : 22 - (DrugBank : 7) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 63
| 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 | NCT04861064 (ClinicalTrials.gov) | January 18, 2022 | 23/4/2021 | Weekly Sirolimus Therapy | Weekly Sirolimus Therapy for the Treatment of Venous and Lymphatic Malformations | Venous Malformation;Lymphatic Malformation | Drug: Sirolimus | Medical University of South Carolina | NULL | Recruiting | 2 Years | N/A | All | 24 | Phase 2 | United States |
| 2 | NCT04921722 (ClinicalTrials.gov) | October 22, 2021 | 6/6/2021 | Percutaneous Administration of Sirolimus in the Treatment of Superficial Complicated Vascular Anomalies | Percutaneous Administration of Sirolimus in the Treatment of Superficial Complicated Vascular Anomalies: a Randomized Controlled Trial | Kaposiform Hemangioendothelioma;Tufted Angioma;Superficial Vascular Anomalies;Superficial Lymphatic Malformations | Drug: Percutaneous sirolimus;Drug: Oral sirolimus | Children's Hospital of Fudan University | NULL | Recruiting | 0 Years | 18 Years | All | 75 | Phase 4 | China |
| 3 | NCT04128722 (ClinicalTrials.gov) | February 14, 2020 | 24/9/2019 | TOPical Sirolimus in linGUal Microcystic Lymphatic Malformation -TOPGUN | TOPical Sirolimus in linGUal Microcystic Lymphatic Malformation -TOPGUN | Lingual Microcystic Lymphatic Malformations | Drug: Sirolimus Oral Liquid Product 1mg/mL | University Hospital, Tours | NULL | Recruiting | 5 Years | N/A | All | 12 | Phase 2 | France |
| 4 | JPRN-UMIN000038973 | 2020/01/06 | 25/12/2019 | A multicenter, phase 3 study assessing efficacy and safety of the Sirolimus (Granules and Tablets) in the Treatment of intractable vascular anomalies | A multicenter, phase 3 study assessing efficacy and safety of the Sirolimus (Granules and Tablets) in the Treatment of intractable vascular anomalies - Sirolimus for Intractable Vascular Anomalies(SIVA) | Kaposiform hemangioendothelioma or Tufted angiomaLymphangioma (cystic lymphatic malformation), lymphangiomatosis (generalized lymphatic anomaly) or Gorham-Stout diseaseVenous malformation or blue rubber bleb nevus syndromeComplex-combined vascular malformations or Klippel-Trenanay-Weber syndrome | An initial dose of sirolimus is single orally administered under fed or fasting condition. Subsequently, the sirolimus dosage is adjusted to achieve trough levels between 5-15 ng/mL. | Gifu University Hospital | NULL | Complete: follow-up continuing | 1months-old | Not applicable | Male and Female | 10 | Phase 3 | Japan |
| 5 | 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 | ||
| 6 | NCT03972592 (ClinicalTrials.gov) | June 5, 2019 | 24/5/2019 | Topical Sirolimus in Cutaneous Lymphatic Malformations | 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 | Vascular Malformations;Lymphatic Malformation | Drug: Topical 0.1% Sirolimus;Drug: Topical Vehicle | University Hospital, Tours | University Hospital, Angers | Recruiting | 6 Years | N/A | All | 55 | Phase 2 | France |
| 7 | 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 | ||
| 8 | 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 | A multicenter, single-arm, prospective study assessing efficacy and safety of the Sirolimus in the Treatment of intractable vascular anomalies - Sirolimus for 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 |
| 9 | NCT00975819 (ClinicalTrials.gov) | October 2009 | 10/9/2009 | Safety and Efficacy Study of Sirolimus in Complicated Vascular Anomalies | A Phase 2 Study - Clinical Trial Assessing Efficacy and Safety of the mTOR Inhibitor Sirolimus in the Treatment of Complicated Vascular Anomalies | Kaposiform 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 Syndromes | Drug: sirolimus | Children's Hospital Medical Center, Cincinnati | NULL | Active, not recruiting | N/A | 31 Years | Both | 60 | Phase 2 | United States |