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 : 22 / 薬物数 : 27 - (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 | 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 | N/A | 18 Years | All | 75 | Phase 4 | China |
| 2 | NCT05050149 (ClinicalTrials.gov) | September 15, 2021 | 8/9/2021 | Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic Malformations | A Multicenter, Phase 2, Open-Label Study Evaluating The Safety And Efficacy of Sirolimus 3.9% Topical Gel (PTX-022) In The Treatment of Microcystic Lymphatic Malformations | Microcystic Lymphatic Malformation | Drug: PTX-022 | Palvella Therapeutics, Inc. | NULL | Recruiting | 13 Years | N/A | All | 15 | Phase 2 | United States |
| 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 | NCT04861064 (ClinicalTrials.gov) | May 18, 2021 | 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 |
| 5 | NCT04409145 (ClinicalTrials.gov) | October 1, 2020 | 11/5/2020 | First in Human Trial of Topical VT30 in Pts With Venous/Lymphatic Malformations Assoc With PIK3CA or TEK Gene Mutations | Open-Label, Intra Subject, Dose Escalation (Part 1) Followed by Randomized, Double Blind, Placebo Controlled (Part 2) Trial of Topical VT30 in Pts With Venous, Lymphatic or Mixed Malformations Associated With PIK3CA or TEK Genetic Mutations | Venous Malformation;Lymphatic Malformation;Venolymphatic Malformation | Drug: VT30 | Venthera, Inc., a BridgeBio company | NULL | Recruiting | 18 Years | 60 Years | All | 51 | Phase 1/Phase 2 | United States |
| 6 | 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 |
| 7 | 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 |
| 8 | 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 | ||
| 9 | 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 |
| 10 | 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 | ||
| 11 | NCT03243019 (ClinicalTrials.gov) | June 25, 2018 | 1/8/2017 | Efficacy of Rapamycin in the Treatment of Cervico-facial Lymphatic Malformations | Evaluation of the Efficacy of Rapamycin in the Treatment of Cervico-facial Lymphatic Malformations of Poor Prognosis | Lymphatic Malformation;Pediatric | Drug: rapamycin;Device: MRI;Biological: Rapamycin dosage | University Hospital, Lille | Ministry of Health, France | Recruiting | 1 Year | 18 Years | All | 28 | Phase 2 | France |
| 12 | 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 | |
| 13 | 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 |
| 14 | JPRN-UMIN000025845 | 2017/03/01 | 25/01/2017 | The efficacy of local injection of indocyanine green for visualizing 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 | |
| 15 | 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 |
| 16 | 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 |
| 17 | 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 | |||
| 18 | JPRN-UMIN000008498 | 2012/07/25 | 24/07/2012 | Propranolol for a treatment of 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 | |
| 19 | 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 |
| 20 | 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 |
| 21 | 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 |
| 22 | 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 |