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 | NCT04994002 (ClinicalTrials.gov) | September 3, 2021 | 20/7/2021 | A Pharmacokinetic, Pharmacodynamic, Safety and Tolerability Study of CERC-006 in Adults With Complex Lymphatic Malformations | A Phase 1b, Open-Label, Pharmacokinetic, Pharmacodynamic, Safety and Tolerability Study of CERC-006 in Adults (Aged 18-31 Years) With Complex Lymphatic Malformations | Lymphatic Malformation | Drug: CERC-006 | Cerecor Inc | NULL | Recruiting | 18 Years | 31 Years | All | 10 | Phase 1 | United States |
| 4 | 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 |
| 5 | 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 |
| 6 | 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 | ||
| 7 | 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 |
| 8 | 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 | ||
| 9 | 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 |
| 10 | JPRN-jRCTs041190036 | 03/08/2017 | 04/06/2019 | Visualization of lymphatic malformation | The efficacy of local injection of indocyanine green for visualizing lymphatic malformation | lymphatic malformation | Local injection of indocyanine green | Aitaro Takimoto | NULL | Recruiting | Not applicable | Not applicable | Both | 25 | Phase 2 | Japan |
| 11 | JPRN-UMIN000025845 | 2017/03/01 | 25/01/2017 | The efficacy of local injection of indocyanine green for visualizing lymphatic malformation | The efficacy of local injection of indocyanine green for visualizing lymphatic malformation - Visualization of lymphatic malformation | lymphatic malformation | Local injection of indocyanine green | Nagoya University Graduate School ofMedicine | NULL | Recruiting | 1years-old | 30years-old | Male and Female | 25 | Not selected | Japan |
| 12 | JPRN-jRCTs031180265 | 10/08/2016 | 13/03/2019 | Study of bleomycin and OK-432 combined scletotherapy for LMs | Clinical study of bleomycin and OK-432 combined local injection sclerotherapy for intractable lymphatic malformations | Lymphangioma (lymphatic malformation, common or cystic lymphatic malformation), and other lymphatic lymphangioma, lymphatic malformation,;D18.1 | OK-432 and bleomycin slolution (0.05 kE / mL and 0.5 mg / mL, respectively) will be injected into the lesion with water-soluble contrast agent Maximum dose of bleomycin is 10 mg /dose and 5 mg/kgBW.Cumulative maximum dose in repeated treatment is 10 mg/kgBW | Fujino Akihiro | NULL | Not Recruiting | Not applicable | Not applicable | Both | 21 | N/A | Japan |
| 13 | NCT02335242 (ClinicalTrials.gov) | May 23, 2015 | 7/1/2015 | Sildenafil for the Treatment of Lymphatic Malformations | Phase 2 Study of Sildenafil for the Treatment of Lymphatic Malformations | Lymphatic Malformations;Lymphatic Diseases | Drug: Sildenafil 20 mg tablets;Other: Placebo tablets (resembling Revatio) | Stanford University | Ann & Robert H Lurie Children's Hospital of Chicago | Active, not recruiting | 6 Months | 10 Years | All | 18 | Phase 2 | United States |
| 14 | ChiCTR-OPC-16008702 | 2014-05-01 | 2016-06-22 | Efficacy and safety of oral sildenafil in the treatment of pediatric lymphatic malformations in China | Sildenafil in the treatment of pediatric lymphatic malformations | pediatric lymphatic malformations | Sildenafil-treated group:oral sildenafil; | Beijing Children's Hospital | NULL | Recruiting | Both | Sildenafil-treated group:40; | China | |||
| 15 | JPRN-UMIN000008498 | 2012/07/25 | 24/07/2012 | Propranolol for a treatment of lymphatic malformation | Propranolol for a treatment of lymphatic malformation - Propranolol study for lymphatic malformation | lymphatic malformation | propranolol therapy | University of Tokyo | NULL | Complete: follow-up complete | Not applicable | 65years-old | Male and Female | 20 | Phase 2 | Japan |
| 16 | NCT01212965 (ClinicalTrials.gov) | September 2010 | 24/9/2010 | Selenium in the Treatment of Complicated Lymphatic Malformations | Pilot Clinical Trial to Estimate the Safety and Efficacy of Selenium in the Treatment of Complicated Lymphatic Malformations in Adolescents and Young Adults | Lymphatic Malformations | Drug: Selenium | Medical College of Wisconsin | NULL | Terminated | 14 Years | 30 Years | Both | 5 | Phase 1 | United States |
| 17 | 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 |
| 18 | NCT00010452 (ClinicalTrials.gov) | April 2000 | 2/2/2001 | Study of Picibanil (OK432) Sclerotherapy in Children With Macrocystic Lymphatic Malformations | Treatment of Cystic Hygroma (Lymphangiomas) in Children- Picibanil(OK432) Sclerotherapy-Multicenter Trial | Lymphatic Malformations | Drug: picibanil | University of Iowa | NULL | Completed | 6 Months | 18 Years | Both | 150 | Phase 2/Phase 3 | United States |
| 19 | NCT03427619 (ClinicalTrials.gov) | January 1, 1998 | 10/1/2018 | OK432 (Picibanil) in the Treatment of Lymphatic Malformations | OK432 (Picibanil) in the Treatment of Lymphatic Malformations | Lymphatic Malformations | Drug: OK432 | Richard JH Smith | NULL | Completed | 6 Months | 17 Years | All | 701 | Phase 4 | United States |