Disease details

臨床試験数 : 6 / 薬物数 : 2 - (DrugBank : 2) / 標的遺伝子数 : 1 - 標的パスウェイ数 : 51

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	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
2	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
3	JPRN-UMIN000029843	2017/11/06	06/11/2017	Sirolimus for the treatment of refractory lymphangiomatosis/ Gorham Stout disease	Sirolimus for the treatment of refractory lymphangiomatosis/ Gorham Stout disease - Sirolimus for the treatment of refractory lymphangiomatosis/ Gorham Stout disease	Refractory lymphangiomatosis, Gorham-Stout disease	Oral sirolimus	Kyushu University Hospital	NULL	Recruiting	8years-old	30years-old	Male and Female	2	Not selected	Japan
4	JPRN-UMIN000016580	2015/02/01	19/02/2015	Sirolimus for the treatment of lymphangiomatosis, Gorham-Stout disease and vascular anomalies	Sirolimus for the treatment of lymphangiomatosis, Gorham-Stout disease and vascular anomalies - Sirolimus for vascular anomalies	Lymphangiomatosis, Gorham-Stout disease and vascular anomalies	Oral sirolimus	Gifu university	NULL	Complete: follow-up complete	Not applicable	30years-old	Male and Female	30	Phase 1,2	Japan
5	JPRN-UMIN000014888	2014/06/01	19/08/2014	Everolimus for the treatment of lymphangiomatosis, Gorham-Stout disease and vascular anomalies	Everolimus for the treatment of lymphangiomatosis, Gorham-Stout disease and vascular anomalies - Everolimus for vascular anomalies	Lymphangiomatosis, Gorham-Stout disease and vascular anomalies	Oral everolimus	Gifu university	NULL	Complete: follow-up complete	Not applicable	30years-old	Male and Female	30	Phase 1	Japan
6	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

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