89. リンパ脈管筋腫症 Lymphangioleiomyomatosis Clinical trials / Disease details
臨床試験数 : 38 / 薬物数 : 38 - (DrugBank : 15) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 118
| 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 | NCT03253913 (ClinicalTrials.gov) | March 31, 2018 | 10/8/2017 | Resveratrol and Sirolimus in Lymphangioleiomyomatosis Trial | Resveratrol and Sirolimus in Lymphangioleiomyomatosis Trial (RESULT) | Lymphangioleiomyomatosis | Drug: Sirolimus;Drug: Resveratrol | University of Cincinnati | National Heart, Lung, and Blood Institute (NHLBI) | Active, not recruiting | 18 Years | N/A | Female | 25 | Phase 2 | United States |
| 2 | NCT03150914 (ClinicalTrials.gov) | January 1, 2018 | 10/5/2017 | Multicenter Interventional Lymphangioleiomyomatosis (LAM) Early Disease Trial | Multicenter Interventional Lymphangioleiomyomatosis (LAM) Early Disease Trial | LAM;Lymphangioleiomyomatosis | Drug: Sirolimus | University of Cincinnati | National Heart, Lung, and Blood Institute (NHLBI);National Center for Advancing Translational Science (NCATS);The LAM Foundation | Recruiting | 18 Years | N/A | Female | 60 | Phase 3 | United States |
| 3 | NCT02432560 (ClinicalTrials.gov) | March 2015 | 4/3/2015 | Safety and Durability of Sirolimus for Treatment of LAM | Multicenter International Durability and Safety of Sirolimus in LAM Trial (MIDAS) | Lymphangioleiomyomatosis | Drug: Sirolimus;Drug: Everolimus | University of Cincinnati | Rare Diseases Clinical Research Network;National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);The LAM Foundation | Recruiting | 18 Years | N/A | Female | 600 | United States | |
| 4 | JPRN-UMIN000016677 | 2015/01/01 | 02/03/2015 | Efficacy and safety of low dose sirolimus in lymphangioleiomyomatosis | Efficacy and safety of low dose sirolimus in lymphangioleiomyomatosis - Low dose sirolimus study | lymphangioleiomyomatosis | sirolimus 1mg/day / sirolimus 2mg/day | National Hospital Organization Kinki-chuo Chest Medical Center | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 20 | Not selected | Japan |
| 5 | NCT02061397 (ClinicalTrials.gov) | March 2014 | 23/1/2014 | Safety of Simvastatin in LAM and TSC | The Safety of Simvastatin (SOS) in Patients With Pulmonary Lymphangioleiomyomatosis (LAM) and With Tuberous Sclerosis Complex (TSC) | Lymphangioleiomyomatosis;Tuberous Sclerosis Complex | Drug: Simvastatin;Drug: Sirolimus Oral Product;Drug: Everolimus Oral Product | University of Pennsylvania | The LAM Foundation | Completed | 18 Years | N/A | Female | 10 | Phase 1/Phase 2 | United States |
| 6 | JPRN-JMA-IIA00096 | 05/09/2012 | 17/08/2012 | multicenter lymphangioleiomyomatosis sirolimus trial for safety | multicenter lymphangioleiomyomatosis sirolimus trial for safety | lymphangioleiomyomatosis | Intervention type:DRUG. Intervention1:Srolimus, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:LAM patients will be medicated with 2mg of sirolimus every day for 2 years and modified dosage between 1mg and 3mg QD depend on the plasma concentration monitoring.. | Koh Nakata, MD, PhD | Yoshikazu InoueKuniaki SeyamaRyushi TazawaToshinori Takada | Completed | >=18 YEARS | No Limit | Female | 65 | Phase 2 | Japan |
| 7 | NCT01687179 (ClinicalTrials.gov) | September 2012 | 2/8/2012 | Safety Study of Sirolimus and Hydroxychloroquine in Women With Lymphangioleiomyomatosis | Targeting Autophagy for the Treatment of TSC and LAM: a Phase I Trial of Hydroxychloroquine and Sirolimus | Lymphangioleiomyomatosis | Drug: Sirolimus and Hydroxychloroquine 200 mg;Drug: Sirolimus and Hydroxychloroquine 400 mg | Brigham and Women's Hospital | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 18 Years | 85 Years | Female | 14 | Phase 1 | United States |
| 8 | JPRN-UMIN000007387 | 2012/03/31 | 01/04/2012 | Clinical trials for long-term administration of sirolimus for lymphangioleiomyomatosis | Clinical trials for long-term administration of sirolimus for lymphangioleiomyomatosis - Long-term administration of sirolimus for lymphangioleiomyomatosis | lymphangioleiomyomatosis | sirolimus | Kobe University Graduate School of Medicine | NULL | Complete: follow-up complete | Not applicable | Not applicable | Female | 1 | Not applicable | Japan |
| 9 | JPRN-JMA-IIA00037 | 01/10/2011 | 15/03/2010 | MLLTS trial | Multicenter Lymphangioleiomyomatosis Long Term Sirolimus Trial | lymphangioleiomyomatosis | Intervention type:DRUG. Intervention1:sirolimus, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:LAM patients will be medicated with 2mg of sirolimus every day for 2 years.. | Koh Nakata, MD, Ph.D | Ryushi Tazawa | Other | >=18 YEARS | No Limit | Female | 50 | Phase 2 | Japan |
| 10 | JPRN-JMA-IIA00011 | 08/05/2008 | 29/06/2007 | Multicenter International Lymphangioleiomyomatosis Efficacy of Sirolimus Trial (The MILES Trial) | Multicenter International Lymphangioleiomyomatosis Efficacy of Sirolimus Trial (The MILES Trial) | Lymphangioleiomyomatosis (LAM) | Intervention type:DRUG. Intervention1:Sirolimus, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:12 months on, 12 months off. Control intervention1:Placebo, Dose form:TABLET, Route of administration:ORAL, Intended dose regimen:12 months on, 12 months off. | Frank McCormack, M.D., University of Cincinnati Medical Center Director, Division of Pulmonary and Critical Care Medicine | a.Alan F. Barker, M.D. - Oregon Health & Sciences University b.Kevin Brown, M.D., - National Jewish Medical & Research Center c.Edwin K. Silverman, M.D., Ph.D. - Harvard/Brigham & Women's Hospital d.James M. Stocks, M.D. - University of Texas Health Centere.James K. Stoller, M.D. - Cleveland Clinic Foundation f.Charlie Strange, M.D. - Medical University of South Carolina g.Bruce Trapnell, M.D.-Cincinnati Children's Medical Centerh.Mark Brantly, M.D.-University of Florida, Gainesvillei.Yosdhikazu Inoue, M.D., National Hospital Organization (NHO) Kinki-Chuo Chest Medical Centerj.Koh Nakata, M.D., Ph.D., Bioscience Medical Research Center, Niigata University Medical and Dental Hospitalk.Joel Moss, M.D., Ph.D-National Institutes of Health | Completed | >=18 YEARS | Female | 120 | Phase 3 | Japan, United States, Canada | |
| 11 | NCT00414648 (ClinicalTrials.gov) | December 2006 | 20/12/2006 | Efficacy and Safety of Sirolimus for Treating Lymphangioleiomyomatosis (LAM) | Lymphangioleiomyomatosis Efficacy and Safety Trial | Lymphangioleiomyomatosis | Drug: Sirolimus;Drug: Placebo sirolimus | Office of Rare Diseases (ORD) | FDA Office of Orphan Products Development | Active, not recruiting | 18 Years | N/A | Female | 120 | Phase 3 | United States;Canada;Japan |
| 12 | NCT00490789 (ClinicalTrials.gov) | October 2005 | 21/6/2007 | Trial of Efficacy and Safety of Sirolimus in Tuberous Sclerosis and LAM | A Trial of the Efficacy and Safety of Sirolimus(Rapamycin)Therapy for Renal Angiomyolipmoas in Patients With Tuberous Sclerosis Complex and Sporadic Lymphangioleiomyomatosis | Tuberous Sclerosis;Lymphangioleiomyomatosis | Drug: sirolimus | Cardiff University | University of Nottingham;St Georges Hospital Medical School;Royal Sussex County Hospital;The Tuberous Sclerosis Association;Wyeth is now a wholly owned subsidiary of Pfizer | Active, not recruiting | 18 Years | 65 Years | Both | 14 | Phase 2 | United Kingdom |
| 13 | NCT00457808 (ClinicalTrials.gov) | December 2002 | 6/4/2007 | Rapamycin Therapy for Patients With Tuberous Sclerosis Complex and Sporadic LAM | Rapamycin Therapy of Angiomyolipomas in Patients With Tuberous Sclerosis Complex and Sporadic Lymphangioleiomyomatosis | Tuberous Sclerosis;Lymphangioleiomyomatosis | Drug: Rapamycin, sirolimus | Children's Hospital Medical Center, Cincinnati | The LAM Foundation;Tuberous Sclerosis Alliance | Completed | 18 Years | 65 Years | Both | 25 | Phase 2 | United States |