Pending ( DrugBank: - )
6 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 7 |
| 19 | ライソゾーム病 | 4 |
| 96 | クローン病 | 19 |
| 97 | 潰瘍性大腸炎 | 34 |
| 113 | 筋ジストロフィー | 4 |
| 302 | レーベル遺伝性視神経症 | 5 |
13. 多発性硬化症／視神経脊髄炎
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| 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 | JPRN-jRCT2021220014 | 01/07/2022 | 25/06/2022 | A Clinical, Imaging and Biomarker Study in Neuromyelitis Optica Spectrum Disorder (NMOSD) with Satralizumab as an Intervention | SAKURABONSAI: CLINICAL, IMAGING AND BIOMARKER OPEN-LABEL STUDY IN NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD) WITH SATRALIZUMAB AS AN INTERVENTION | Neuromyelitis Optica Spectrum Disorder (NMOSD) | Satralizumab: 120 mg SC injection every 4 weeks (Q4W) | Regine Buffels | NULL | Pending | >= 18age old | <= 74age old | Both | 100 | Phase 4 | United States;Canada;Italy;France;Germany;India;Korea;Turkey;Japan |
| 2 | ChiCTR2200057880 | 2022-04-01 | 2022-03-20 | A prospective, self-controlled study to explore efficacy and safety of orelabrutinib in AQP4-IgG positive neuromyelitis optica spectrum disorder | A prospective, self-controlled study to explore efficacy and safety of orelabrutinib in AQP4-IgG positive neuromyelitis optica spectrum disorder | Neuromyelitis optica spectrum disorder | Case group:Orelabrutinib, orally, 50 mg QD; | Peking Union Medical College Hospital | NULL | Pending | 18 | 75 | Both | Case group:23; | Phase 1 | China |
| 3 | ChiCTR2100052936 | 2021-11-10 | 2021-11-06 | The establishment of metabolic fingerprints-aided diagnostic model of neuromyelitis optica spectrum disorder | High-throughput metabolic fingerprints characterize neuromyelitis optica spectrum disorder | Neuromyelitis Optica Spectrum Disorders | Gold Standard:Cell-based assay (CBA) for antibody testing as recommended.;Index test:Matrix-assisted laser desorption/ionization mass spectrometry (MALDI MS) is responsible for the obtainment of biofluid metabolic fingerprints, which is further processed by machine learning algorithm, yielding Receiver Operating Characteristic (ROC) curve and area under curve (AUC) calculated to provide comparison.; | Renji Hospital, School of Medicine, Shanghai Jiao Tong University | NULL | Pending | 18 | 85 | Both | Target condition:76;Difficult condition:13 | N/A | China |
| 4 | JPRN-UMIN000043910 | 2021/06/01 | 01/06/2021 | Association between brain atrophy and intestinal permeability in patients with multiple sclerosis | Association between brain atrophy and intestinal permeability in patients with multiple sclerosis - Brain atrophy and intestinal permeability in MS | multiple sclerosis | A standard solution of lactulose (5 g) and mannitol (2 g)in 500 mL of tap water was ingested before bed. Urine was collected the following morning in a container (with 5 mL of thymol solution). | Department of Neurology and Neurological Science, Tokyo Medical and Dental University | NULL | Pending | 18years-old | 80years-old | Male and Female | 40 | Not selected | Japan |
| 5 | ChiCTR2100043013 | 2021-01-31 | 2021-02-04 | Efficacy difference between low dose rituximab and mycophenolate mofetil in preventing recurrence of NMOSD | Efficacy difference between low dose rituximab and mycophenolate mofetil in preventing recurrence of NMOSD | Neuromyelitis optica spectrum diseases | low dose rituximab group: low dose rituximab ;mycophenolate mofetil group:mycophenolate mofetil ; | Shandong University Qilu Hospital | NULL | Pending | Both | low dose rituximab group:30;mycophenolate mofetil group:30; | Phase 4 | China | ||
| 6 | ChiCTR2000034098 | 2020-07-01 | 2020-06-23 | A New Quantitative Method Used to Evaluate Cervical Spinal Cord Damage in Multiple Sclerosis: Diffusional Kurtosis Imaging Research | A New Quantitative Method Used to Evaluate Cervical Spinal Cord Damage in Multiple Sclerosis: Diffusional Kurtosis Imaging Research | Multiple Sclerosis | Gold Standard:Conventional cervical MRI;Index test:Diffusional Kurtosis Imaging; | The First Hospital of Jilin University | NULL | Pending | Both | Target condition:48;Difficult condition:0 | China | |||
| 7 | EUCTR2011-000985-36-ES (EUCTR) | 22/02/2013 | 25/01/2012 | Study on the Use of surface electromyography in the detection of objective differencies in patients with spasticity due to multiple sclerosis identified as responders and not responders under treatment with Sativex | Study on the Use of surface electromyography in the detection of objective differencies in patients with spasticity due to multiple sclerosis identified as responders and not responders under treatment with Sativex | Spasticity due to multiple sclerosis identified as responders and not responders under treatment with Sativex MedDRA version: 14.1;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: SATIVEX Product Name: sativex Product Code: N02BG10 INN or Proposed INN: pending Other descriptive name: CANNABIDIOL | JOSE MANUEL GARCIA DOMINGUEZ | NULL | Not Recruiting | Female: yes Male: yes | Spain |
19. ライソゾーム病
臨床試験数 : 899 / 薬物数 : 684 - (DrugBank : 99) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 182
| 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 | JPRN-UMIN000023517 | 2016/10/01 | 01/10/2016 | A study on the efficacy and safety of cyclodextrin intrathecal long-term administration for Niemann-Pick disease type C | A study on the efficacy and safety of cyclodextrin intrathecal long-term administration for Niemann-Pick disease type C - IT-HPBCD therapy for NPC (Long-term) | Niemann-Pick disease type C | 2-hydroxypropyl-beta-cyclodextrin (HPBCD) 20mg/kg/dose, every 3-4 weeks, for three years | Nara Medical University | NULL | Pending | 4years-old | 6years-old | Male and Female | 1 | Not selected | Japan |
| 2 | EUCTR2015-001875-32-PT (EUCTR) | 18/04/2016 | 19/01/2016 | A long-term safety and efficacy study in MPS 7 patients receiving enzyme (UX003) replacement by intravenous injection | A Long-Term Open-Label Treatment and Extension Study of UX003 rhGUS Enzyme Replacement Therapy in Subjects with MPS 7 | Mucopolysaccharidosis type 7 ( MPS 7, Sly syndrome);Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Recombinant human beta-glucuronidase (rhGUS) Product Code: UX003 INN or Proposed INN: pending Other descriptive name: RECOMBINANT HUMAN BETA GLUCURONIDASE; RHGUS | Ultragenyx Pharmaceutical Inc. | NULL | Not Recruiting | Female: yes Male: yes | 12 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Mexico;Brazil | ||
| 3 | EUCTR2015-000104-26-Outside-EU/EEA (EUCTR) | 23/07/2015 | A safety and efficacy study in young MPS 7 patients (less than 5 years old) receiving enzyme (UX003) replacement by intravenous injection | An Open-label Study of UX003 rhGUS Enzyme Replacement Therapy in MPS 7 Patients Less than 5 years old | Mucopolysaccharidosis type 7 (MPS 7, Sly syndrome);Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Recombinant human betaglucuronidase Product Code: UX003 INN or Proposed INN: pending Other descriptive name: RECOMBINANT HUMAN BETA GLUCURONIDASE; RHGUS | Ultragenyx Pharmaceutical Inc. | NULL | NA | Female: yes Male: yes | 7 | United States | ||||
| 4 | EUCTR2015-001875-32-Outside-EU/EEA (EUCTR) | 12/11/2015 | A long-term safety and efficacy study in MPS 7 patients receiving enzyme (UX003) replacement by intravenous injection | A Long-Term Open-Label Treatment and Extension Study of UX003 rhGUS Enzyme Replacement Therapy in Subjects with MPS 7 | Mucopolysaccharidosis type 7 (MPS 7, Sly syndrome);Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Recombinant human beta-glucuronidase Product Code: UX003 INN or Proposed INN: pending Other descriptive name: RECOMBINANT HUMAN BETA GLUCURONIDASE; RHGUS | Ultragenyx Pharmaceutical Inc. | NULL | NA | Female: yes Male: yes | 12 | United States |
96. クローン病
臨床試験数 : 2,442 / 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
| 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 | JPRN-jRCT2031220309 | 01/11/2022 | 01/09/2022 | A Study of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn's Disease - DUET-CD | Crohn's Disease | Guselkumab Guselkumab will be administered as subcutaneous injection. Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. Golimumab Golimumab will be administered as subcutaneous injection. Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (High-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Mid-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Low-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Particip | Nishikawa Kazuko | NULL | Pending | >= 18age old | <= 65age old | Both | 715 | Phase 2 | Argentina;Australia;Austria;Belgium;Bulgaria;Brazil;Canada;Switzerland;Chile;China;Czechia;Germany;Denmark;Spain;Estonia;France;United Kingdom Of Great Britain;Greece;Hungary;India;Israel;Italy;Korea;Republic Of Lithuania;Mexico;Netherlands;Norway;Poland;Portugal;Serbia;Japan |
| 2 | JPRN-jRCT2031220205 | 22/08/2022 | 08/07/2022 | A Study of Guselkumab in Participants with Fistulizing, Perianal Crohn's Disease | A Phase 3,Randomized,Placebo-controlled,Parallel-group,Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants with Fistulizing, Perianal Crohn's Disease - FUZION CD | Fistulizing Crohns Disease Perianal Crohns Disease | Guselkumab:Drug:Group 1: Guselkumab:Group 2: Guselkumab:Group 3: Placebo:Guselkumab will be administered subcutaneously/IV infusion. Placebo:Drug:Group 1: Guselkumab:Group 2: Guselkumab:Group 3: Placebo:Matching placebo will be administered subcutaneously/IV infusion. | Numaguchi Hirotaka | NULL | Pending | >= 18age old | Not applicable | Both | 280 | Phase 3 | Australia;Spain;Italy;Saudi Arabia;Belgium;France;Jordan;Sweden;Canada;United Kingdom Of Great Britain;Republic Of Korea;Turkey;Czechia;Greece;Netherlands;Taiwan;Germany;Hungary;Poland;United States Of America;Egypt;Israel;Portugal;Japan |
| 3 | JPRN-jRCT2031210678 | 22/08/2022 | 18/03/2022 | A Study of Guselkumab Subcutaneous Therapy in Participants with Moderately to Severely Active Crohn's Disease | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn's Disease - GRAVITI | Crohn Disease | Guselkumab Dose 1:Drug:Group 1: Guselkumab,Group 2: Guselkumab:Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection. Guselkumab Dose 2:Drug:Group 1: Guselkumab:Guselkumab (Dose 2) will be administered by SC injection. Guselkumab Dose 3:Drug:Group 2: Guselkumab:Guselkumab (Dose 3) will be administered by SC injection. Placebo:Drug:Group 3: Placebo:Placebo will be administered by SC injection. | Hirotaka Numaguchi | NULL | Pending | >= 18age old | Not applicable | Both | 318 | Phase 3 | Australia;Belarus;Belgium;Bosnia And Herzegovina;Brazil;Canada;China;Croatia;Czechia;Germany;Hungary;Italy;Jordan;Korea;France;Lithuania;Netherlands;NewZealand;Poland;RussianFederation;Serbia;Slovakia;Spain;Taiwan,Province Of China;Turkey;Ukraine;United Kingdom Of Great Britain;UnitedStates Of America;Japan |
| 4 | JPRN-jRCT2031220186 | 10/08/2022 | 06/07/2022 | A Basket Long-term Extension Study of Ustekinumab in Pediatric Participants | A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age) | Crohn Disease, Ulcerative Colitis, Psoriatic Arthritis | Participants will have continued access to ustekinumab for primary study (CNTO1275CRD1001, CNTO1275PUC3001, CNTO1275CRD3004 & CNTO1275JPA3001) participants who in the opinion of the investigator will continue to benefit from ustekinumab therapy. All blinded participants who enroll in the long-term extension (LTE) from blinded primary studies with both every 8 weeks (q8w) and every 12 weeks (q12w) dosing groups just prior to the end of the primary study will be assigned to the q8w dosing regimen. Participants enrolling in the LTE from an unblinded primary study will remain on the final dosing regimen that they were receiving in the primary study. Ustekinumab will be administered as a SC injection. | Nishikawa Kazuko | NULL | Pending | >= 2age old | < 18age old | Both | 151 | Phase 3 | France;Poland;United States Of America;Japan |
| 5 | ChiCTR2200058343 | 2022-04-13 | 2022-04-07 | To investigate the effect of pancreatin on diarrhea of crohn's disease patients taking total enteral nutrition | To investigate the effect of pancreatin on diarrhea of crohn's disease patients taking total enteral nutrition | Crohn's disease | Experimental group:Take trypsin medications; | Renmin Hospital of Wuhan University | NULL | Pending | 18 | 75 | Both | Experimental group:53; | Phase 4 | China |
| 6 | ChiCTR2200058055 | 2022-04-01 | 2022-03-27 | A prospective, multicenter observational study of adalimumab biological analogues combined with partial enteral nutrition in the evaluation of the efficacy of Crohn's disease | A prospective, multicenter observational study of adalimumab biological analogues combined with partial enteral nutrition in the evaluation of the efficacy of Crohn's disease | Inflammatory bowel disease (IBD) | Hemienteral nutrition group:adalimumab biological analogues combined with partial enteral nutrition therapy;Internal nutrition group:adalimumab combined with total enteral nutrition;The adamumab group:adalimumab; | The First Affiliated Hospital of Shantou University Medical College | NULL | Pending | 18 | 75 | Both | Hemienteral nutrition group:30;Internal nutrition group:30;The adamumab group:60; | N/A | China |
| 7 | JPRN-jRCT2031210677 | 18/03/2022 | 18/03/2022 | A study to test whether spesolimab helps people with Crohn's disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn's Disease | fibrostenotic Crohn's Disease | Investigational Drug: Spesolimab, Placebo Dose: 1200 mg spesolimab or placebo every 4 weeks (Day 1 to Week 8), then 1200 mg spesolimab or placebo every 8 weeks until Week 40 Mode of Administration: intervenous | Taguchi Aya | NULL | Pending | >= 18age old | <= 75age old | Both | 3 | Phase 2 | Australia;Austria;Belgium;Brazil;Canada;China;Denmark;France;Germany;Ireland;Israel;Italy;Republic of Korea;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Serbia;Spain;Sweden;Switzerland;Taiwan;United Kingdom;United States;Japan |
| 8 | ChiCTR2100048717 | 2021-07-01 | 2021-07-13 | Clinical trial of the efficacy and safety of dipyridamole adjuvant therapy in children with IBD | Clinical trial of the efficacy and safety of dipyridamole adjuvant therapy in children with IBD | Crohn's disease | Two groups:Oral dipyridamole; | Guangzhou Women and Children's Medical Center | NULL | Pending | 3 | 18 | Both | Two groups:50; | China | |
| 9 | JPRN-UMIN000043165 | 2021/02/01 | 31/01/2021 | Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease | Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease - Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease | Crohn's disease, Ulcerative colitis, IBDU | witching from originator infliximab to infliximab biosimilar CT-P13 | Fukuoka University Chikushi Hospital | NULL | Pending | Not applicable | Not applicable | Male and Female | 220 | Not selected | Japan |
| 10 | ChiCTR2000036845 | 2021-01-01 | 2020-08-25 | A single-center, randomized, controlled study on the effect of proactive therapeutic drug monitoring on the efficacy and cost of adamumab in the treatment of Crohn's disease | A single-center, randomized, controlled study on the effect of proactive therapeutic drug monitoring on the efficacy and cost of adamumab in the treatment of Crohn's disease | Crohn's disease | Proctive treatment drug monitoring group:In the proactive TDM group, adamumab is 160mg at week 0, 80mg at week 2, and 40mg once every two weeks from week 4 until week 8. Adalimumab serum trough concentration is going to be monitored at week 8, 16, 24, 32 and 40 after inclusion: 1.If serum trough concentration=11.7 g/ mL, continue&#;Reactive treatment drug monitoring group:In the reactive TDM group, adamumab is 160mg at week 0, 80mg at week 2, and 40mg once every two weeks from week 4 until week 8. Clinical response is assesed at week 8, 16, 24, 32, and 40 after inclusion: 1.If the clinical response is achieved, continue to administer 40mg once every ; | Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine | NULL | Pending | 18 | 70 | Both | Proctive treatment drug monitoring group:60;Reactive treatment drug monitoring group:60; | Phase 4 | China |
| 11 | ChiCTR2000035737 | 2020-10-01 | 2020-08-16 | Application of indocyanine green fluorescence angiography in preventing anastomotic recurrence after Crohn’s disease intestinal resection and anastomosis: a single-center, prospective, randomized controlled trial | Application of indocyanine green fluorescence angiography in preventing anastomotic recurrence after Crohn’s disease intestinal resection and anastomosis: a single-center, prospective, randomized controlled trial | Crohn's disease | Experimental group:The scope of surgical resection was determined by indocyanine green fluorescence angiography;Control group:The scope of surgical resection (2cm away from the lesion site) determined by the physician based on experience; | Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine | NULL | Pending | 18 | 70 | Both | Experimental group:45;Control group:45; | China | |
| 12 | ChiCTR2000031344 | 2020-05-01 | 2020-03-28 | Endoscopic Stricturotomy combined with local injection of bleomycin in the treatment of primary anorectal stricture in crohn's disease: a Prospective, double-blind, randomized controlled clinical study | Endoscopic Stricturotomy combined with local injection of bleomycin in the treatment of primary anorectal stricture in crohn's disease: a Prospective, double-blind, randomized controlled clinical study | Crohn's disease | Group 1:Endoscopic Stricturotomy;Group 2:Endoscopic Stricturotomy combined with local bleomycin injection; | The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine | NULL | Pending | Both | Group 1:35;Group 2:35; | China | |||
| 13 | ChiCTR2000029323 | 2020-03-01 | 2020-01-25 | Laparoscopic bowel resection combined with infliximab treatment versus infliximab for localized intestinal Crohn's disease: a randomized controlled, open-label trial | Laparoscopic bowel resection combined with infliximab treatment versus infliximab for localized intestinal Crohn's disease: a randomized controlled, open-label trial | Crohn's disease | Experimental group:Laparoscopic bowel resection combined with postoperative Infliximab treatment;Control group:Infliximab; | Renji Hospital, School of Medicine, Shanghai Jiaotong University | NULL | Pending | 18 | 80 | Both | Experimental group:30;Control group:30; | China | |
| 14 | ChiCTR1900026091 | 2019-09-19 | 2019-09-20 | Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease | Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease: a multicenter study | Crohn's disease | Case series:infliximab; | The First Affiliated Hospital of Sun Yat-sen University | NULL | Pending | 9 | 58 | Both | Case series:343; | China | |
| 15 | JPRN-JapicCTI-194830 | 01/7/2019 | 27/06/2019 | Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn's Disease] | Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Crohn's Disease] | Crohn's disease | Intervention name : Vedolizumab (Genetical Recombination) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Vedolizumab (Genetical Recombination) 300 milligrams (mg), intravenous (IV) infusion, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants will receive IV infusion as part of routine medical care. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Takeda Pharmaceutical Company Limited | NULL | pending | BOTH | 300 | NA | Japan | ||
| 16 | ChiCTR1900023696 | 2019-07-01 | 2019-06-08 | Endoscopic balloon dilatation combined with local betamethasone injection to prevent recurrence of anastomotic stenosis after ileocolic resection for Crohn's disease: a single-center prospective randomized controlled trial | Endoscopic balloon dilatation combined with local betamethasone injection to prevent recurrence of anastomotic stenosis after ileocolic resection for Crohn's disease: a single-center prospective randomized controlled trial | Chron's disease | Group 1:EBD;Group 2:EBD combined with local injection of betamethasone; | The Sixth Affiliated Hospital of Sun Yat-sen University | NULL | Pending | 18 | 75 | Both | Group 1:45;Group 2:45; | N/A | China |
| 17 | ChiCTR1900022728 | 2019-05-01 | 2019-04-23 | Cohort study combined with omics screening for the early diagnostic markers in Crohn's disease | Cohort study combined with omics screening for the early diagnostic markers in Crohn's disease | Crohn's disease | Gold Standard:Clinical outcome;Index test:Comprehensive serological markers, metabolomics, intestinal microbes, pathological features, imaging features of clinical subclinical CD, combined with clinical and endoscopic features, to explore early diagnosis of CD; | The 7th Medical Center of the PLA General Hospital (Army general hospital) | NULL | Pending | Both | Target condition:310;Difficult condition:160 | China | |||
| 18 | EUCTR2018-003303-19-PL (EUCTR) | 15/03/2019 | 23/01/2019 | A Phase II Study in Patients With Moderate to Severe Active Crohn’s Disease. | A Phase II randomized, placebo controlled, double-blind, 4 arms dose-ranging study to evaluate the efficacy and safety of SHR0302 compared to placebo in patients with moderate to severe active Crohn’s Disease. | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHR0302 INN or Proposed INN: Pending | Reistone Biopharma Company Limited | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | United States;Poland;Ukraine;China | ||
| 19 | ChiCTR1800015174 | 2018-05-01 | 2018-03-12 | Effects of Vitamin D supplementation on clinical prognosis for patients with Crohn's disease | Effects of Vitamin D supplementation on clinical prognosis for patients with Crohn's disease | Crohn's disease | control group:placebo;Vitamin D:800IU Vitamin D; | Gudangdong General Hospital, Guangdong Academy of Medical Sciences | NULL | Pending | 18 | 75 | Both | control group:32;Vitamin D:32; | China |
97. 潰瘍性大腸炎
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| 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 | JPRN-jRCT2031220308 | 01/11/2022 | 01/09/2022 | A Study of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis - DUET-UC | Colitis, Ulcerative | Guselkumab Guselkumab will be administered as subcutaneous injection. Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. Golimumab Golimumab will be administered as subcutaneous injection. Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (High-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Mid-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Low-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Particip | Nishikawa Kazuko | NULL | Pending | >= 18age old | <= 65age old | Both | 550 | Phase 2 | Argentina;Australia;Austria,;Belgium;Bulgaria;Brazil;Canada;Switzerland;Chile;Czechia;Germany;Denmark;Spain;Estonia;France;United Kingdom Of Great Britain;Greece;Hungary;India;Israel;Italy;Korea;Republic Of Lithuania;Mexico;Netherlands;Norway;NewZealand;Poland;Portugal;Serbia;Japan |
| 2 | JPRN-jRCT2031220186 | 10/08/2022 | 06/07/2022 | A Basket Long-term Extension Study of Ustekinumab in Pediatric Participants | A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age) | Crohn Disease, Ulcerative Colitis, Psoriatic Arthritis | Participants will have continued access to ustekinumab for primary study (CNTO1275CRD1001, CNTO1275PUC3001, CNTO1275CRD3004 & CNTO1275JPA3001) participants who in the opinion of the investigator will continue to benefit from ustekinumab therapy. All blinded participants who enroll in the long-term extension (LTE) from blinded primary studies with both every 8 weeks (q8w) and every 12 weeks (q12w) dosing groups just prior to the end of the primary study will be assigned to the q8w dosing regimen. Participants enrolling in the LTE from an unblinded primary study will remain on the final dosing regimen that they were receiving in the primary study. Ustekinumab will be administered as a SC injection. | Nishikawa Kazuko | NULL | Pending | >= 2age old | < 18age old | Both | 151 | Phase 3 | France;Poland;United States Of America;Japan |
| 3 | JPRN-jRCT2021220013 | 01/07/2022 | 18/06/2022 | A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis | A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis with an Inadequate Response to Conventional Therapy | Ulcerative Colitis (UC) | Ozanimod High Dose Ozanimod Low Dose | Liu W. Jerry | NULL | Pending | >= 2age old | <= 17age old | Both | 120 | Phase 2-3 | France;United States;Japan |
| 4 | ITMCTR2200006063 | 2022-06-05 | 2022-06-05 | A systematic study on the syndrome differentiation standard of lingnan wet syndrome - ulcerative colitis | A systematic study on the syndrome differentiation standard of lingnan wet syndrome - ulcerative colitis | Ulcerative colitis | No intervention:No intervention;Pure western medicine intervention:Mesalazine ;Intervention of integrated Chinese and Western medicine:Mesalazine + invigorating spleen and removing dampness;Simple Chinese medicine intervention:Shenling Baizhu powder + special prescription; | Guangdong Provincial Hospital of Chinese Medicine | NULL | Pending | 18 | 75 | Both | No intervention:25;Pure western medicine intervention:25;Intervention of integrated Chinese and Western medicine:25;Simple Chinese medicine intervention:25; | Phase 1 | China |
| 5 | ChiCTR2200059150 | 2022-05-05 | 2022-04-26 | Study on the mechanism of Qingchangxiaopi Decoction and UC large intestine damp-heat syndrome from the activation of LPDC through TLR5-IRF4 pathway to mediate intestinal inflammation | Study on the mechanism of Qingchangxiaopi Decoction and UC large intestine damp-heat syndrome from the activation of LPDC through TLR5-IRF4 pathway to mediate intestinal inflammation | Ulcerative colitis (UC) | Intervention group:Qingchangxiaopi Decoction;Control group:Mesalazine; | Dongguan Hospital of Guangzhou University of Chinese Medinine | NULL | Pending | 18 | 70 | Both | Intervention group:30;Control group:30; | China | |
| 6 | JPRN-jRCTs052210199 | 22/03/2022 | 22/03/2022 | Comparison of GI tract pH and motility between patients with ulcerative colitis and healthy controls | Comparison of total gastrointestinal pH and motility between healthy subjects and patients with ulcerative colitis using wireless motility/pH capsule | Ulcerative colitis | arm UC arm Health control In each case, the SmartPill motility capsule is orally taken with 50 ml of water. The temperature, pH and pressure of the entire digestive tract are measured in real time. Also, the transit time of each of the stomach, small intestine, and large intestine is calculated from the transit time of the capsule. | Nakamura Shiro | Higuchi Kazuhide | Pending | >= 20age old | <= 79age old | Both | 25 | N/A | Japan |
| 7 | JPRN-jRCT2051210087 | 17/09/2021 | 22/09/2021 | Safety and pharmacokinetics study in healthy Japanese volunteers | A Phase 1 study to assess the safety, tolerability and pharmacokinetics after single and multiple doses of ABX464 capsules in healthy Japanese volunteers. - Safety and pharmacokinetics study in healthy Japanese volunteers | Ulcerative colitis | Part A Part A includes the following two dose regimen groups: - 25 mg dose regimen group: ABX464 25 mg or placebo - 50 mg dose regimen group: ABX464 50 mg or placebo In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects). Enrolment will start with the 25 mg dose regimen group. Following a blinded review of available safety data by the DSMB after the subjects of the first dose regimen have received the study treatment (ABX464, 9 subjects and placebo, 3 subjects), the 50 mg dose regimen group will open for enrolment and receive the study treatment. For each dose regimen group, subjects will be admitted to the study center on D?1, administered the study treatment on D1, orally in the morning in the standardized fed conditions, and discharged from the study center on D4 after completion of study assessments. Subjects will visit the study center on D8 and D15 (End of Study [EoS] visit) for PK and safety assessments. Body weight, vital signs, laboratory parameters including renal and hepatic markers, will be evaluated at screening and at each visit to the study center. Part B Following a blinded review of available safety and PK data by the DSMB after the subjects of part A have received the study treatment (ABX464 or placebo), the part B will start for enrolment. Part B includes the following two dose regimen groups: - 25 mg dose regimen group: ABX464 25 mg or placebo for 28 days - 50 mg dose regimen group: ABX464 50 mg or placebo for 28 days In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects). Enrolment will start with the 25 mg dose regimen. | Owada Yasuko | NULL | Pending | >= 20age old | <= 45age old | Male | 48 | Phase 1 | Japan |
| 8 | ITMCTR2100005038 | 2021-07-15 | 2021-07-09 | Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials | Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials | Ulcerative Colitis | Experimental group:SLBZP Granule and Mesalazine;Control group:Mesalazine; | The First Affiliated Hospital of Guangzhou University of Chinese Medicine | NULL | Pending | 18 | 75 | Both | Experimental group:3;Control group:3; | N/A | China |
| 9 | ChiCTR2100048502 | 2021-07-15 | 2021-07-09 | Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials | Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials | Ulcerative Colitis | Experimental group:SLBZP Granule and Mesalazine;Control group:Mesalazine; | The First Affiliated Hospital of Guangzhou University of Chinese Medicine | NULL | Pending | 18 | 75 | Both | Experimental group:3;Control group:3; | N/A | China |
| 10 | ChiCTR2100048176 | 2021-07-12 | 2021-07-04 | A randomized controlled trial of Xuyan decoction in the treatment of ulcerative colitis with spleen deficiency and dampness-blocking syndrome in remission period | A randomized controlled trial of Xuyan decoction in the treatment of ulcerative colitis with spleen deficiency and dampness-blocking syndrome in remission period | Ulcerative colitis | Experimental group:Xuyan Decoction;Control group:Mesalazine sustained-release granules; | Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | NULL | Pending | 18 | 65 | Both | Experimental group:44;Control group:44; | China | |
| 11 | ITMCTR2100005012 | 2021-07-12 | 2021-07-04 | A randomized controlled trial of Xuyan decoction in the treatment of ulcerative colitis with spleen deficiency and dampness-blocking syndrome in remission period | A randomized controlled trial of Xuyan decoction in the treatment of ulcerative colitis with spleen deficiency and dampness-blocking syndrome in remission period | Ulcerative colitis | Control group:Mesalazine sustained-release granules;Experimental group:Xuyan Decoction; | Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | NULL | Pending | 18 | 65 | Both | Control group:44;Experimental group:44; | China | |
| 12 | JPRN-UMIN000043165 | 2021/02/01 | 31/01/2021 | Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease | Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease - Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease | Crohn's disease, Ulcerative colitis, IBDU | witching from originator infliximab to infliximab biosimilar CT-P13 | Fukuoka University Chikushi Hospital | NULL | Pending | Not applicable | Not applicable | Male and Female | 220 | Not selected | Japan |
| 13 | ChiCTR2000035497 | 2020-10-01 | 2020-08-13 | A multicenter, randomized, controlled trial of Qingyu Powder in the treatment of mild to moderate active ulcerative colitis | A multicenter, randomized, controlled trial of Qingyu Powder in the treatment of mild to moderate active ulcerative colitis | ulcerative colitis | Experimental group:Qingyusan;Control group:Mesalazine; | Shuguang Hospital affiliated to Shanghai University of traditional Chinese Medicine | NULL | Pending | Both | Experimental group:40;Control group:40; | China | |||
| 14 | ITMCTR2000003558 | 2020-10-01 | 2020-08-13 | A multicenter, randomized, controlled trial of Qingyu Powder in the treatment of mild to moderate active ulcerative colitis | A multicenter, randomized, controlled trial of Qingyu Powder in the treatment of mild to moderate active ulcerative colitis | ulcerative colitis | Experimental group:Qingyusan;Control group:Mesalazine; | Shuguang Hospital affiliated to Shanghai University of traditional Chinese Medicine | NULL | Pending | Both | Experimental group:40;Control group:40; | China | |||
| 15 | ChiCTR2000032498 | 2020-09-01 | 2020-04-30 | Human experimental study on the effect of probiotics combined with prebiotics on ulcerative colitis: a randomized double-blind controlled trial | Human experimental study on the effect of probiotics combined with prebiotics on ulcerative colitis | Ulcerative colitis | Experimental group:Probiotics and prebiotics;placebo group:maltodextrin; | Capital Medical University | NULL | Pending | Both | Experimental group:15;placebo group:15; | China | |||
| 16 | ChiCTR2000033953 | 2020-07-01 | 2020-06-18 | Effect of the probiotic on symptoms in patients with ulcerative colitis (UC) | Effect of the probiotic on symptoms in patients with ulcerative colitis (UC) | Ulcerative colitis | Placebo group:Maltodextrin;experimental group 1:Lactobacillus plantarum CCFM8610;experimental group 2:Lactobacillus plantarum N13;experimental group 3:Lactobacillus casei CCFM1059; | Jiangnan University | NULL | Pending | Both | Placebo group:20;experimental group 1:20;experimental group 2:20;experimental group 3:20; | China | |||
| 17 | ChiCTR1900025900 | 2019-12-01 | 2019-09-13 | Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial. | Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial. | Ulcerative colitis | Experimental group:Mesalazine+DHEP II;control group:Mesalazine+Compound Huangbai lotion; | Nanjing Hospital of Chinese Medicine | NULL | Pending | Both | Experimental group:200;control group:100; | Phase 3 | China | ||
| 18 | ITMCTR1900002594 | 2019-12-01 | 2019-09-13 | Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial. | Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial. | Ulcerative colitis | Experimental group:Mesalazine+DHEP II;control group:Mesalazine+Compound Huangbai lotion; | Nanjing Hospital of Chinese Medicine | NULL | Pending | Both | Experimental group:200;control group:100; | Phase 3 | China | ||
| 19 | ChiCTR1900024086 | 2019-08-01 | 2019-06-24 | Modified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled Trials | Modified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled Trials | Ulcerative Colitis | intervention period:Modified Chinese Medicine Granule and Mesalazine placebo;control period:Mesalazine and Modified Chinese Medicine Granule placebo; | The First Affiliated Hospital of Guangzhou University of Chinese Medicine | NULL | Pending | 18 | 75 | Both | intervention period:10;control period:10; | N/A | China |
| 20 | ITMCTR1900002423 | 2019-08-01 | 2019-06-24 | Modified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled Trials | Modified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled Trials | Ulcerative Colitis | intervention period:Modified Chinese Medicine Granule and Mesalazine placebo;control period:Mesalazine and Modified Chinese Medicine Granule placebo; | The First Affiliated Hospital of Guangzhou University of Chinese Medicine | NULL | Pending | 18 | 75 | Both | intervention period:10;control period:10; | N/A | China |
| 21 | ITMCTR1900002475 | 2019-07-22 | 2019-07-18 | Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis | Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis | Ulcerative colitis | Combined Group:Prednisone+New Wumeiwan Formula+Mesalazine Enteric-coated tablets(Salofalk);Convenience medicine Group:Prednisone+Mesalazine Enteric-coated tablets (Salofalk);TCM Group:Prednisone+New Wumeiwan Formula; | Peking University First Hospital | NULL | Pending | 18 | 65 | Both | Combined Group:40;Convenience medicine Group:40;TCM Group:40; | CHINA | |
| 22 | ChiCTR1900024591 | 2019-07-22 | 2019-07-18 | Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis | Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis | Ulcerative colitis | TCM Group:Prednisone+New Wumeiwan Formula;Convenience medicine Group:Prednisone+Mesalazine Enteric-coated tablets (Salofalk);Combined Group:Prednisone+New Wumeiwan Formula+Mesalazine Enteric-coated tablets(Salofalk); | Peking University First Hospital | NULL | Pending | 18 | 65 | Both | TCM Group:40;Convenience medicine Group:40;Combined Group:40; | China | |
| 23 | EUCTR2018-003364-31-PL (EUCTR) | 15/03/2019 | 23/01/2019 | A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis. | A Phase II randomized, placebo controlled, double-blind, 4 arms dose-ranging study to evaluate the efficacy and safety of SHR0302 compared to placebo in patients with moderate to severe active Ulcerative Colitis. | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHR0302 INN or Proposed INN: Pending | Reistone Biopharma Company Limited | NULL | Not Recruiting | Female: yes Male: yes | 152 | Phase 2 | United States;Poland;Ukraine;China | ||
| 24 | ChiCTR1900021229 | 2019-02-18 | 2019-02-02 | The role of fecal calprotectin in the treatment of patients with clinically quiescent ulcerative colitis | The role of fecal calprotectin in the treatment of patients with clinically quiescent ulcerative colitis | Ulcerative colitis | Intervention group:Increasing the dose of mesalamine according to fecal calprotectin levels;Control group:Maintaining current dosage of mesalamine; | Beijing Friendship Hospital, Capital Medical University | NULL | Pending | Both | Intervention group:74;Control group:74; | China | |||
| 25 | ChiCTR1800019676 | 2018-12-01 | 2018-11-22 | Diagnostic Value of probe-based Confocal Laser Endomicroscopy Score for assessment of numosal healing of ulcerative colitis | Diagnostic Value of probe-based Confocal Laser Endomicroscopy Score for assessment of numosal healing of ulcerative colitis: a single center, prospective cohort study | ulcerative colitis | Gold Standard:Histopathological examination;Index test:1, Gland density (grade) 2. Gland morphology (grade) 3. Vascular changes (grade); | Peking University First Hospital | NULL | Pending | 18 | 80 | Both | Target condition:40;Difficult condition:0 | China | |
| 26 | ChiCTR1800016438 | 2018-06-30 | 2018-06-01 | Clinical research of flupentixol-melitracen and mesalazine on ulcerative colitis | Clinical research of flupentixol-melitracen and mesalazine on ulcerative colitis | ulcerative colitis | control:mesalazine 1 po qid;observation group:mesalazine 1 po qid; flupentixol-melitracen 1pill po tid; | Guiyang 1st People's Hospital | NULL | Pending | 15 | 75 | Both | control:30;observation group:30; | China | |
| 27 | JPRN-UMIN000030988 | 2018/02/01 | 01/02/2018 | Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy | Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy - Comparison of maintenance treatment between azathioprine and adalimumab after induction of tacrolimus in ulcerative colitis therapy (CAT study) | Ulcerative Colitis | Induce azathioprine and continue maintenance therapy by azathioprine Induce adalimumab and continue maintenance therapy by adalimumab | Sakura Medical Center, Toho university | NULL | Pending | 15years-old | Not applicable | Male and Female | 53 | Not applicable | Japan |
| 28 | ChiCTR-IPR-17010306 | 2017-02-01 | 2017-01-01 | Effects of probiotics on intestinal microecological reconstruction in patients with ulcerative colitis | Effects of probiotics on intestinal microecological reconstruction in patients with ulcerative colitis | Ulcerative colitis | Group A:Mesalazine combined with placebo; Group B:Methalazine combined with probiotics;Group C:Probiotics combined with placebo;Normal control group:Blank control; | Affiliated Hospital of Inner Mongolia Medical University | NULL | Pending | 18 | Both | Group A:30; Group B:30;Group C:30;Normal control group:30; | China | ||
| 29 | JPRN-UMIN000019066 | 2015/09/25 | 18/09/2015 | An open label randomized controlled trial of combination therapy of Adalimumab and GMA for intractable ulcerative colitis | An open label randomized controlled trial of combination therapy of Adalimumab and GMA for intractable ulcerative colitis - An open label randomized controlled trial of combination therapy of Adalimumab and GMA for intractable ulcerative colitis | Ulcerative colitis | Administration of Adalimumab 160 mg at baseline, 80 mg at 2 weeks and 40 mg every 2 weeks. In addition to Adalimumab Therapy, co-treatment of GMA 3times a week up to 2 weeks | Sakura Medical Center,Toho university | NULL | Pending | 20years-old | Not applicable | Male and Female | 58 | Not applicable | Japan |
| 30 | JPRN-UMIN000018745 | 2015/09/01 | 01/09/2015 | The Efficacy of Enternal Nutrition in Active Ulcerative Colitis Patients with Hypoalbuminemia ,during Infliximab Therapy | The Efficacy of Enternal Nutrition in Active Ulcerative Colitis Patients with Hypoalbuminemia ,during Infliximab Therapy - The Efficacy of Enternal Nutrition in Active Ulcerative Colitis Patients with Hypoalbuminemia ,during Infliximab Therapy | ulcerative colitis | Administration of Infliximab and enteral nutrition Administration of Infliximab | Nagoya University Graduate School of Medicine, Department of Gastroentrology and hepatology | NULL | Pending | 15years-old | 75years-old | Male and Female | 40 | Not selected | Japan |
| 31 | ChiCTR-IPR-15005760 | 2015-01-12 | 2015-01-02 | Steroid-dependent ulcerative colitis pathogenesis of complex multi-center alternative medicine therapy, randomized, controlled clinical study | Steroid-dependent ulcerative colitis pathogenesis of complex multi-center alternative medicine therapy, randomized, controlled clinical study | ulcerative colitis | TCM Group:Oral Chinese medicine Qinchang Lianyang Granule + Guanchang Fang granule;Control:Azathioprine; | Affiliated Hospital of Nanjing University of Chinese Medicine | NULL | Pending | 18 | 65 | Both | TCM Group:60;Control:60; | I (Phase 1 study) | China |
| 32 | JPRN-UMIN000013546 | 2014/06/01 | 31/03/2014 | The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus | The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus - Effect of grapefruit juice with Tacrolimus | rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitis | take a glass of grapefruit juice every day do not take grapefruit juice | Department of Rheumatology and Clinical Immunology, Kyoto University Hospital | NULL | Pending | 16years-old | 80years-old | Male and Female | 20 | Not applicable | Japan |
| 33 | JPRN-UMIN000013033 | 2014/02/01 | 01/02/2014 | Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis. | Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis. - Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis | Ulcerative colitis | Study start - 14 weeks:5mg/kg of Infliximab for 0.2.6.14 week, respectively ( initial administration day with 0 weeks) | Department of Internal Medicine,Juntendo University | NULL | Pending | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 34 | JPRN-UMIN000013266 | 2013/05/01 | 25/02/2014 | Randomized controlled study comparing 1% of Dermacrin A ointmentwith 0.033% of Guaiazulene ointment for patients with perianal delmatitis after total colectomy | Randomized controlled study comparing 1% of Dermacrin A ointmentwith 0.033% of Guaiazulene ointment for patients with perianal delmatitis after total colectomy - Controlled study of Dermacrin A for patients with perianal delmatitis after total colectomy | ulcerative colitis, familial adenomatous polyposis | 1% of Dermacrin A ointment 0.033% of Guaiazulene ointment | Mie University Graduate School of Medicine, Gastrointestinal and Pediatric Surgery | NULL | Pending | 20years-old | Not applicable | Male and Female | 30 | Not applicable | Japan |
113. 筋ジストロフィー
臨床試験数 : 646 / 薬物数 : 471 - (DrugBank : 105) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 170
| 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 | ChiCTR2100050052 | 2021-09-01 | 2021-08-16 | Observational study of Lonafarnib in Chinese patients with progeria and progeroid laminopathy | Observational study of Lonafarnib in Chinese patients with progeria and progeroid laminopathy | Hutchinson-Gilford Progeria Syndrome and Progeroid Laminopathies | Experimental group:Treatment with Lonafarnib; | The Children's Hospital Zhejiang University School of Medicine | NULL | Pending | 1 | 99 | Both | Experimental group:25; | N/A | China |
| 2 | EUCTR2019-000305-79-ES (EUCTR) | 14/05/2019 | 12/04/2019 | An extension study to the A083-02 and A083-03 studies that evaluate the long-term effect of the ACE-083 investigational product in patients with Facioscapulohumeral Muscular Dystrophy (FSHD) previously participated in study A083-02 and also in patients with Charcot-Marie Tooth (CMT) disease type 1 and X who previously participated in study A083-03. | An Open-Label Extension Study to Evaluate the Long-Term Effects of ACE-083 in Patients with Facioscapulohumeral Muscular Dystrophy (FSHD) Previously Enrolled in Study A083-02 and in Patients with Charcot-Marie Tooth (CMT) Disease Types 1 and X Previously Enrolled in Study A083-03 | Facioscapulohumeral Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10064087;Term: Facioscapulohumeral muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ACE-083 Product Code: ACE-083 INN or Proposed INN: pending Other descriptive name: ACE-083 | Acceleron Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Spain | ||
| 3 | EUCTR2016-003257-15-ES (EUCTR) | 12/04/2018 | 04/01/2018 | A Phase 2 clinical trial that is randomized and controlled by a placebo (similar to the product under investigation but does not have any therapeutic effect) of ACE-083 in Patients with muscular dystrophy (on face, around shoulder blades, in upper arms). The study is a double-blind study, this means that neither you nor your doctor will know if you receive study drug or placebo | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ACE-083 in Patients with Facioscapulohumeral Muscular Dystrophy | Facioscapulohumeral Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10064087;Term: Facioscapulohumeral muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ACE-083 Product Code: ACE-083 INN or Proposed INN: pending Other descriptive name: ACE-083 | Acceleron Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Spain | ||
| 4 | EUCTR2015-004333-27-GB (EUCTR) | 19/01/2016 | 04/11/2015 | A clinical trial to test how the study medication (SMT C1100) works and how safe it is when given to children with Duchenne Muscular Dystrophy | A Phase 2 Clinical Study to Assess the Activity and Safety of Utrophin Modulation with SMT C1100 in Ambulatory Paediatric Male Subjects with Duchenne Muscular Dystrophy (C11005) - PoC Study to Assess Activity and Safety of SMT C1100 in Boys with DMD | Duchenne Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Code: SMT C1100 INN or Proposed INN: Pending | Summit (Oxford) Limited | NULL | Not Recruiting | Female: no Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;United Kingdom |
302. レーベル遺伝性視神経症
臨床試験数 : 23 / 薬物数 : 15 - (DrugBank : 5) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 33
| 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 | EUCTR2015-001265-11-IT (EUCTR) | 18/03/2016 | 04/11/2020 | A Phase III gene therapy clinical trial in LHON Subjects Affected for 6 Months or Less | Sperimentazione clinica pilota, randomizzata, in doppio cieco, controllata con simulazione per valutare l'efficacia di un'unica iniezione intravitreale di GS010 (rAAV2/2-ND4) in soggetti affetti, per un periodo di 6 mesi o inferiore, da neuropatia ottica ereditaria di Leber a causa della mutazione G11778A nel gene mitocondriale NADH deidrogenasi 4 - RESCUE | Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene MedDRA version: 20.1;Level: LLT;Classification code 10062951;Term: Leber's hereditary optic atrophy neuropathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Product Name: Recombinant AAV vector serotype 2 containing the human wild type mitochondrial ND4 gene Product Code: GS010 INN or Proposed INN: PENDING Other descriptive name: RAAV2/2-ND4 VECTOR | GENSIGHT BIOLOGICS | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;France;Germany;United Kingdom;Italy | ||
| 2 | EUCTR2015-001266-26-DE (EUCTR) | 21/01/2016 | 11/08/2015 | A Phase III gene therapy clinical trial in LHON Subjects Affected for more than 7months or more | A Randomized, Double-Masked, Sham-Controlled, Pivotal Clinical Trial to Evaluate the Efficacy of a Single Intravitreal Injection of GS010 (rAAV2/2-ND4) in Subjects Affected for more than 6 months and to 12 mounths by Leber Hereditary Optic Neuropathy Due to the G11778A Mutation in the Mitochondrial NADH Dehydrogenase 4 Gene | Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Product Name: Recombinant AAV vector serotype 2 containing the human wild type mitochondrial ND4 gene Product Code: GS010 INN or Proposed INN: pending Other descriptive name: RAAV2/2-ND4 VECTOR | GENSIGHT-BIOLOGICS | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Germany;Italy;United Kingdom | ||
| 3 | EUCTR2015-001265-11-DE (EUCTR) | 21/01/2016 | 11/08/2015 | A Phase III gene therapy clinical trial in LHON Subjects Affected for 6 Months or Less | A Randomized, Double-Masked, Sham-Controlled, Pivotal Clinical Trial to Evaluate the Efficacy of a Single Intravitreal Injection of GS010 (rAAV2/2-ND4) in Subjects Affected for 6 Months or Less by Leber Hereditary Optic Neuropathy Due to the G11778A Mutation in the Mitochondrial NADH Dehydrogenase 4 Gene | Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Product Name: Recombinant AAV vector serotype 2 containing the human wild type mitochondrial ND4 gene Product Code: GS010 INN or Proposed INN: pending Other descriptive name: RAAV2/2-ND4 VECTOR | GENSIGHT-BIOLOGICS | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Germany;Italy;United Kingdom | ||
| 4 | EUCTR2015-001266-26-GB (EUCTR) | 08/10/2015 | 15/06/2016 | A Phase III gene therapy clinical trial in LHON Subjects Affectedfor more 7 months | A Randomized, Double-Masked, Sham-Controlled, Pivotal Clinical Trial to Evaluate the Efficacy of a Single Intravitreal Injection of GS010 (rAAV2/2-ND4) in Subjects Affected for more than 6 Months and to 12 months by Leber Hereditary Optic Neuropathy Due to the G11778A Mutation in the Mitochondrial NADH Dehydrogenase 4 Gene | Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Product Name: Recombinant AAV vector serotype 2 containing the human wild type mitochondrial ND4 gene Product Code: GS010 INN or Proposed INN: pending Other descriptive name: RAAV2/2-ND4 VECTOR | GENSIGHT-BIOLOGICS | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;France;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2015-001265-11-GB (EUCTR) | 08/10/2015 | 20/05/2016 | A Phase III gene therapy clinical trial in LHON Subjects Affectedfor 6 Months or Less | A Randomized, Double-Masked, Sham-Controlled, Pivotal ClinicalTrial to Evaluate the Efficacy of a Single Intravitreal Injection of GS010 (rAAV2/2-ND4) in Subjects Affected for 6 Months or Less by Leber Hereditary Optic Neuropathy Due to the G11778A Mutation in the Mitochondrial NADH Dehydrogenase 4 Gene | Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Product Name: Recombinant AAV vector serotype 2 containing the human wild type mitochondrial ND4 gene Product Code: GS010 INN or Proposed INN: pending Other descriptive name: RAAV2/2-ND4 VECTOR | GENSIGHT-BIOLOGICS | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | France;United States;Germany;Italy;United Kingdom |