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 | 2 |
| 19 | ライソゾーム病 | 3 |
| 96 | クローン病 | 11 |
| 97 | 潰瘍性大腸炎 | 20 |
| 113 | 筋ジストロフィー | 0 |
| 302 | レーベル遺伝性視神経症 | 3 |
| 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 | 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 | |||
| 2 | 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 |
| 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 | 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-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 | ||||
| 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 |
| 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 | 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 |
| 2 | 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 | |
| 3 | JPRN-JapicCTI-205298 | 10/6/2020 | 26/05/2020 | A Study of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Intervention name : Guselkumab INN of the intervention : Guselkumab Dosage And administration of the intervention : Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Janssen Pharmaceutical K.K. | NULL | pending | 18 | BOTH | 25 | Phase 3 | Japan | |
| 4 | 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 | |||
| 5 | 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 | |
| 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 |
| 6 | 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 | |
| 7 | 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 | ||
| 8 | 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 |
| 9 | 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 | |||
| 10 | 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 | |
| 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 |
| 11 | JPRN-UMIN000024566 | 2016/11/01 | 01/11/2016 | Study on the selection of appropriate patients for the dose escalation of adalimumab in Crohn's disease therapy. | Crohn'disease | Dose escalation group Administration of Adalimumab 80 mg every other week Non-dose escalation group Administration of Adalimumab 40 mg every other week | Toho University Medical Center Sakura Hospital | NULL | Pending | 16years-old | Not applicable | Male and Female | 60 | Not applicable | Japan |
| 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-jRCTs011200009 | 06/11/2020 | 06/11/2020 | vedolizumab-4026 | A study to evaluate the relationship between the pharmacokinetics of vedolizumab in the colon tissue and in the serum concentrations, alpha4beta7 integrin receptor occupancy and the efficacy in subjects with moderately to severely active ulcerative colitis and treated by vedolizumab IV - vedolizumab-4026 | Subjects with UC | Vedolizumab 300 mg is administered at Week 0, 2, 6 and every 8 weeks thereafter. Treatment duration is 46 weeks. | Fujiya Mikihiro | Fernandez Jovelle;Takeda Pharmaceutical Company Limited (Takeda) | Pending | >= 20age old | <= 80age old | Both | 30 | Phase 4 | Japan |
| 2 | 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 | |||
| 3 | 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 | |||
| 4 | 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 | |||
| 5 | 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 | ||
| 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 |
| 6 | 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 |
| 7 | 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 | |
| 8 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 152 | Phase 2 | United States;Poland;Ukraine;China | ||
| 9 | 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 | |||
| 10 | 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 | |
| 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 |
| 11 | 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 | |
| 12 | 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 | 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 | |
| 13 | 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 | ||
| 14 | 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 | 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 | |
| 15 | JPRN-UMIN000018745 | 2015/09/01 | 01/09/2015 | 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 | |
| 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 |
| 16 | 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 |
| 17 | JPRN-UMIN000013546 | 2014/06/01 | 31/03/2014 | The effect ofgrepefruit juice on the patients with autoimmune diseases taking 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 | |
| 18 | JPRN-UMIN000013033 | 2014/02/01 | 01/02/2014 | 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 | |
| 19 | 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 | 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 | |
| 20 | JPRN-JapicCTI-184217 | 22/11/2018 | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (I6T-MC-AMBG) | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (I6T-MC-AMBG) | Ulcerative Colitis | Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : intravenous injection, Subcutaneous injection Control intervention name : Placebo INN of the control intervention : Placebo Dosage And administration of the control intervention : intravenous injection, Subcutaneous injection | Eli Lilly Japan K.K. | NULL | pending | 18 | 80 | BOTH | Phase 3 | NULL |
| 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-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 | ||
| 3 | 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 |