277. Lymphangiomatosis Clinical trials / Disease details


Clinical trials : 6 Drugs : 2 - (DrugBank : 2) / Drug target gene : 1 - Drug target pathways : 51

  
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1JPRN-UMIN000038973
2020/01/0625/12/2019A multicenter, phase 3 study assessing efficacy and safety of the Sirolimus (Granules and Tablets) in the Treatment of intractable vascular anomaliesA 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 syndromeAn 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 HospitalNULLComplete: follow-up continuing1months-oldNot applicableMale and Female10Phase 3Japan
2JPRN-UMIN000030522
2017/11/1422/12/2017A multicenter, single-arm, prospective study assessing efficacy and safety of the Sirolimus in the Treatment of intractable vascular anomaliesA 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 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
3JPRN-UMIN000029843
2017/11/0606/11/2017Sirolimus for the treatment of refractory lymphangiomatosis/ Gorham Stout diseaseSirolimus for the treatment of refractory lymphangiomatosis/ Gorham Stout disease - Sirolimus for the treatment of refractory lymphangiomatosis/ Gorham Stout disease Refractory lymphangiomatosis, Gorham-Stout diseaseOral sirolimusKyushu University HospitalNULLRecruiting8years-old30years-oldMale and Female2Not selectedJapan
4JPRN-UMIN000016580
2015/02/0119/02/2015Sirolimus for the treatment of lymphangiomatosis, Gorham-Stout disease and vascular anomaliesSirolimus for the treatment of lymphangiomatosis, Gorham-Stout disease and vascular anomalies - Sirolimus for vascular anomalies Lymphangiomatosis, Gorham-Stout disease and vascular anomaliesOral sirolimusGifu universityNULLComplete: follow-up completeNot applicable30years-oldMale and Female30Phase 1,2Japan
5JPRN-UMIN000014888
2014/06/0119/08/2014Everolimus for the treatment of lymphangiomatosis, Gorham-Stout disease and vascular anomaliesEverolimus for the treatment of lymphangiomatosis, Gorham-Stout disease and vascular anomalies - Everolimus for vascular anomalies Lymphangiomatosis, Gorham-Stout disease and vascular anomaliesOral everolimusGifu universityNULLComplete: follow-up completeNot applicable30years-oldMale and Female30Phase 1Japan
6NCT00975819
(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