193. プラダー・ウィリ症候群 Prader-Willi syndrome Clinical trials / Disease details
臨床試験数 : 111 / 薬物数 : 120 - (DrugBank : 30) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 103
| 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 | ChiCTR2100046551 | 2021-05-18 | 2021-05-21 | Multimodal magnetic resonance imaging changes in Prader-Willi syndrome before and after growth hormone treatment | Application of multimodal magnetic resonance imaging in pre - and post-treatment evaluation of recombinant human growth hormone in children with Prader-Willi syndrome | Prader-Willi sydrome | Prader-Willi sydrome group treated with rhGH:Treat with rhGH;Prader-Willi sydrome group treated without rhGH:Basic medicine;Normal development group:none; | Cai Jinhua | NULL | Recruiting | 0 | 16 | Both | Prader-Willi sydrome group treated with rhGH:40;Prader-Willi sydrome group treated without rhGH:40;Normal development group:40; | N/A | China |
| 2 | JPRN-jRCT2031200351 | 09/02/2021 | 08/02/2021 | Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWS | A PHASE 3 MULTICENTER, OPEN LABEL, MULTI COHORT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SOMATROPIN IN JAPANESE PARTICIPANTS WITH PRADER-WILLI SYNDROME (PWS) - NA | Prader-Willi Syndrome | Biological: somatropin - GH naive pediatric cohort somatropin 0.245 mg/kg/week Biological: somatropin - GH treated cohort somatropin 0.084 mg/kg/week Biological: somatropin - adult cohort somatropin 0.084 mg/kg/week | Nagashima Masahito | NULL | Recruiting | >= | Not applicable | Both | 30 | Phase 3 | Japan |
| 3 | NCT04697381 (ClinicalTrials.gov) | February 9, 2021 | 4/1/2021 | Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWS | A PHASE 3 MULTICENTER, OPEN LABEL, MULTI COHORT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SOMATROPIN IN JAPANESE PARTICIPANTS WITH PRADER-WILLI SYNDROME (PWS) | Prader-Willi Syndrome | Biological: somatropin - GH naïve pediatric cohort;Biological: somatropin - GH treated cohort;Biological: somatropin - adult cohort | Pfizer | NULL | Active, not recruiting | N/A | N/A | All | 32 | Phase 3 | Japan |
| 4 | NCT04484051 (ClinicalTrials.gov) | October 1, 2020 | 15/7/2020 | Global Growth Hormone Study in Adults With Prader-Willi Syndrome | Global Growth Hormone Study in Adults With Prader-Willi Syndroom | Prader-Willi Syndrome | Drug: Somatropin;Drug: Placebo | Erasmus Medical Center | Pfizer;Foundation for Prader-Willi Research;Prader-Willi Fonds | Not yet recruiting | 30 Years | N/A | All | 50 | Phase 3 | Australia;Netherlands |
| 5 | ChiCTR1900027464 | 2019-12-01 | 2019-11-14 | Efficacy and safety of anastrozole combined with growth hormone in the treatment of Prader Willi syndrome in boys of large bone age | Efficacy and safety of anastrozole combined with growth hormone in the treatment of Prader Willi syndrome in boys of large bone age | Prader-Willi syndrome | control group:Single rhGH therapy;observation group:Anastrazole combined with growth hormone therapy; | Children's Hospital of Zhejiang University School of Medicine | NULL | Pending | Male | control group:20;observation group:20; | Phase 4 | China | ||
| 6 | ChiCTR1900022809 | 2019-05-01 | 2019-04-26 | Efficacy and safety of growth hormone in the treatment of Prader-Willi syndrome | Efficacy and safety of growth hormone in the treatment of Prader-Willi syndrome | Prader-Willi syndrome | control group:Routine treatment such as rehabilitation;Treated group:treatment with growth hormone; | Children's Hospital of Zhejiang University School of Medicine | NULL | Pending | Both | control group:20;Treated group:50; | N/A | China | ||
| 7 | NCT03554031 (ClinicalTrials.gov) | April 14, 2018 | 30/5/2018 | A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi Syndrome | A Single Arm, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi Syndrome | Prader-Willi Syndrome | Drug: Recombinant Human Growth Hormone (rhGH) Injection | GeneScience Pharmaceuticals Co., Ltd. | Children's Hospital of Fudan University;Tongji medical college huazhong university of science & technology;Beijing Children's Hospital;Peking University First Hospital;Peking Union Medical College Hospital;The Children's Hospital of Zhejiang University School of Medicine | Unknown status | 1 Month | 5 Years | All | 30 | Phase 3 | China |
| 8 | EUCTR2017-002164-41-ES (EUCTR) | 03/07/2017 | 21/06/2017 | Study with adult patients with Prader-Willi syndrome, which evaluate the effect of growth hormone therapy on muscle tone and its relation with muscle strength and body composition assessed with imaging procedures. | Growth hormone therapy in adults with Prader-Willi syndrome: Effect on muscle tone assessed by functional magnetic resonance imaging (fMRI) and its relation to muscle strenght and body composition. | Patients with Prader-Willi Syndrome (SPW) with Growth hormone deficit. MedDRA version: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Genotonorm Miniquick 0,2 mg INN or Proposed INN: RECOMBINANT HUMAN GROWTH HORMON Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Fundació Parc Taulí | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Spain | |||
| 9 | NCT03616509 (ClinicalTrials.gov) | June 19, 2017 | 27/7/2018 | GH in Adults With PWS, Effect on Hypotonia Evaluated by Functional MRI, Relationship With Strength and Body Composition | Treatment With Growth Hormone in Adults With PWS, Effect on Muscular Tone Evaluated by Functional MRI, Relationship With Strength and Body Composition | Prader-Willi Syndrome | Drug: Growth hormone;Drug: Placebo | Corporacion Parc Tauli | Parc de Salut Mar | Completed | 18 Years | N/A | All | 30 | Phase 4 | Spain |
| 10 | NCT02205450 (ClinicalTrials.gov) | September 2014 | 30/7/2014 | Experience With Growth Hormone (GH) in Children Under 2 Years With Prader-Willi Syndrome (PWS) in the Pediatric Endocrine Department of the Hospital of Sabadell | Experience With Growth Hormone (GH) in Children Under 2 Years With Prader-Willi Syndrome (PWS) in the Pediatric Endocrine Department of the Hospital of Sabadell | Prader-Willi Syndrome | Drug: Recombinant Somatropin | Corporacion Parc Tauli | NULL | Not yet recruiting | N/A | 2 Years | Both | 15 | N/A | Spain |
| 11 | EUCTR2011-001313-14-NL (EUCTR) | 17/10/2012 | 12/01/2012 | Young adult Prader-Willi StudyEffects of Growth Hormone after final height:A clinical care study to the optimal dosage of growth hormone in young adults with PWS. | Young adult Prader-Willi StudyEffects of Growth Hormone after final height:A clinical care study to the optimal dosage of growth hormone in young adults with PWS. - Young Adult Prader Willi study | Prader Willi Syndrome MedDRA version: 14.1;Level: LLT;Classification code 10041331;Term: Somatotrophin;System Organ Class: 10022891 - Investigations;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: GENOTROPIN (Somatropin) is a growth hormone treatment. It is an exact copy of the natural growth hormone that our bodies make. The main difference is that GENOTROPIN is man-made. Product Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: growth hormone | Dutch growth research foundation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 12 | NCT01401244 (ClinicalTrials.gov) | July 14, 2011 | 20/7/2011 | Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers | A Trial to Examine the Bioequivalence of Norditropin® Versus Genotropin® in Healthy Adult Volunteers | Genetic Disorder;Prader-Willi Syndrome;Growth Disorder;Idiopathic Short Stature;Healthy | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | 18 Years | 40 Years | All | 30 | Phase 1 | United States |
| 13 | NCT01298180 (ClinicalTrials.gov) | January 2009 | 6/11/2009 | Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome? | Is There a Sensibility Increased in the Growth Hormone at Child With Prader-Willi Syndrome? | Prader-Willi Syndrome;Growth Hormone Deficiency | Drug: Growth hormone (Genotonorm® or Omnitrope®);Procedure: DEXA, blood tests, H.G.P.O, osseous age.;Procedure: biopsy | University Hospital, Toulouse | NULL | Completed | 1 Year | 5 Years | All | 111 | Phase 4 | France |
| 14 | NCT00705172 (ClinicalTrials.gov) | November 2008 | 24/6/2008 | Retrospective Observational Study on Efficacy and Safety of Norditropin® in Children With Prader-Willi Syndrome | Efficacy and Safety of Norditropin® (Somatropin) in Children With Prader-Willi Syndrome (PWS) | Genetic Disorder;Prader-Willi Syndrome | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | 15 Years | Both | 41 | N/A | Denmark;Germany;Switzerland |
| 15 | EUCTR2007-004716-31-NL (EUCTR) | 05/03/2008 | 06/11/2007 | Effects of growth hormone treatment after final height in Prader-Willi Syndrome: A double-blind multicenter, cross-over study on the effects of growth hormone versus placebo on body composition and psychosocial behaviour in transition - Effects of GH after final height in PWS | Effects of growth hormone treatment after final height in Prader-Willi Syndrome: A double-blind multicenter, cross-over study on the effects of growth hormone versus placebo on body composition and psychosocial behaviour in transition - Effects of GH after final height in PWS | Prader-Willi Syndrome MedDRA version: 9.1;Level: LLT;Classification code 10036476;Term: Prader-Willi syndrome | Trade Name: Genotropin | Dutch Growth Foundation | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 16 | EUCTR2007-000469-39-FI (EUCTR) | 02/05/2007 | 12/02/2007 | An Open Label Follow-up Study of Patients Who Participated in Clinical Study B9R-HL-GDDV. A Phase IV, one-arm follow-up study to assess final adult results of GH treatment in patients with the Prader-Willi Syndrome. - NA | An Open Label Follow-up Study of Patients Who Participated in Clinical Study B9R-HL-GDDV. A Phase IV, one-arm follow-up study to assess final adult results of GH treatment in patients with the Prader-Willi Syndrome. - NA | Prader-Willi syndrome MedDRA version: 9.1;Level: LLT;Classification code 10036476;Term: Prader-Willi syndrome | Trade Name: Humatrope 6 mg/12 mg/24 mg injektiokuiva-aine ja liuotin, liuosta varten INN or Proposed INN: SOMATROPIN | Oy Eli Lilly Finland Ab | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Finland | |||
| 17 | NCT00372125 (ClinicalTrials.gov) | April 2005 | 5/9/2006 | Nordic Study on the Effects of Growth Hormone (Norditropin SimpleXx) Treatment in Adults With Prader-Willi Syndrome | Nordic Study on the Effects of Growth Hormone (Norditropin SimpleXx) Treatment in Adults With Prader-Willi Syndrome | Prader-Willi Syndrome | Drug: Norditropin SimpleXx | Karolinska University Hospital | Novo Nordisk A/S | Completed | 18 Years | 50 Years | Both | 46 | N/A | Denmark;Norway;Sweden |
| 18 | NCT00444964 (ClinicalTrials.gov) | April 2005 | 6/3/2007 | Growth Hormone Use in Adults With Prader-Willi Syndrome | Growth Hormone Use in Adults With Prader-Willi Syndrome | Prader-Willi Syndrome | Drug: Nutropin AQ | Children's Mercy Hospital Kansas City | NULL | Recruiting | 16 Years | 60 Years | Both | 10 | Phase 3 | United States |