Corticosteroids (DrugBank: -)
10 diseases告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
41 | 巨細胞性動脈炎 | 2 |
46 | 悪性関節リウマチ | 11 |
49 | 全身性エリテマトーデス | 5 |
64 | 血栓性血小板減少性紫斑病 | 2 |
97 | 潰瘍性大腸炎 | 26 |
107 | 若年性特発性関節炎[全身型若年性特発性関節炎(~2018.3)] | 1 |
164 | 眼皮膚白皮症 | 1 |
220 | 急速進行性糸球体腎炎 | 1 |
296 | 胆道閉鎖症 | 2 |
300 | IgG4関連疾患 | 1 |
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 | NCT04012905 (ClinicalTrials.gov) | November 5, 2020 | 5/7/2019 | Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering | A Randomized, Controled, Open Label Trial: Comparison Between Two Standardized Corticosteroids Tapering, Respectively Short (North American) and Long (European), in Giant Cell Arteritis | Giant Cell Arteritis | Drug: Corticosteroids for Systemic Use | University Hospital, Caen | University Hospital, Lille;Amiens University Hospital;University Hospital, Rouen;University Hospital, Limoges;Central Hospital Saint Quentin;Central Hospital, Valenciennes;Central Hospital, Lisieux | Not yet recruiting | 50 Years | N/A | All | 150 | Phase 3 | NULL |
2 | NCT01791153 (ClinicalTrials.gov) | July 22, 2013 | 12/2/2013 | An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA) | A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis | Giant Cell Arteritis | Drug: Tocilizumab;Drug: Prednisone;Drug: Tocilizumab Placebo;Drug: Prednisone Placebo;Drug: Corticosteroids;Drug: Methotrexate | Hoffmann-La Roche | NULL | Completed | 50 Years | N/A | All | 251 | Phase 3 | United States;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Spain;Sweden;United Kingdom;Austria |
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-jRCTs041200048 | 02/10/2020 | 02/10/2020 | Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state | Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state - PRIMERA study | Rheumatoid arthritis | 1) MTX* - Continued group: Continued at a stable dose and interval throughout the cours of the study. Folic acid is continued if concomitantly used. - Withdrawn group: Week 0 to 12 Reduced after registration. The dose of MTX is reduced to half, regardless of the initial dose. Folic acid is continued if concomitantly used. Week 12 to 52 Discontinued if low disease activity was maintained. Folic acid is discontinued if concomitantly used. *The allowable range of adherence is -20% to +20%. 2) CZP and csDMARDs other than MTX Continued at a stable dose and interval throughout the course of the study in both groups. 3) Glucocorticoids Continued at a stable dose up to week 36, and allowedto taper after week 36 in both group. 4) Rescue treatment One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request. - Restoring, restarting, or increasing doses of MTX - Increasing doses of or adding csDMARDs other than MTX. - Increasing doses of or adding glucocorticoids - Drainage of synovial fluid. - Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine. | Kojima Toshihisa | NULL | Recruiting | >= 20age old | Not applicable | Both | 114 | N/A | Japan |
2 | JPRN-jRCT1041190125 | 09/03/2020 | 09/03/2020 | PRECIOUS-B study | Patient REported, Clinical, and Imaging OUtcomes of tapering methotrexate in patients with rheumatoid arthritis in Stable low disease activity with Baricitinib - PRECIOUS-B study | Rheumatoid arthritis | 1) MTX* Week 0 to 12 - Reduced after registration. - The dosing frequency of MTX is decreased from weekly to biweekly without a change in dose, regardless of the initial dose. - The dosing frequency of folic acid is decreased from weekly to biweekly without a change in dose if concomitantly used. Week 12 to 52 - Discontinued if low disease activity was maintained. - Folic acid is discontinued if concomitantly used. *The allowable range of adherence is -20% to +20%. 2) BAR - Continued at a stable dose and interval throughout the course of the study. 3) csDMARDs other than MTX - Continued at a stable dose and interval throughout the course of the study. 4) Glucocorticoids - Continued at a stable dose up to week 36, and allowed to taper after week 36. 5) Rescue treatments One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request - Changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX. - Increasing doses of or adding csDMARDs other than MTX. - Increasing doses of or adding glucocorticoids. - Drainage of synovial fluid. - Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine. | Takahashi Nobunori | NULL | Pending | >= 20age old | Not applicable | Both | 51 | N/A | Japan |
3 | NCT04485325 (ClinicalTrials.gov) | November 4, 2019 | 30/4/2020 | Capability of Tofacitinib or Etanercept to Accelerate Tapering of NSAID and Treat-to-target Guided De-escalation of Corticosteroids in RA Patients | Capability of Tofacitinib or Etanercept to Accelerate Clinical Relevant Tapering of Non-steroidal Anti-inflammatory Drugs (NSAID) and Treat-to-target Guided De-escalation of Corticosteroids in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Previous csDMARD Therapy (AcceleRAte) | Rheumatic Arthritis | Drug: Tofacitinib;Biological: Etanercept | Dr. Frank Behrens | Pfizer | Recruiting | 18 Years | 65 Years | All | 192 | Phase 4 | Germany |
4 | EUCTR2018-004539-54-DE (EUCTR) | 03/06/2019 | 10/04/2019 | Capability of Tofacitinib or Etanercept to accelerate clinical relevant dose reduction of non-steroidal anti-inflammatory drugs and treat-to-target guided minimization of intake of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy | Capability of Tofacitinib or Etanercept to accelerate clinical relevant tapering of non-steroidal anti-inflammatory drugs and treat-to-target guided de-escalation of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy - AcceleRAte | Patients with active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Xeljanz Trade Name: Enbrel Trade Name: Celebrex | Fraunhofer Fraunhofer Gesellschaft for its Fraunhofer Institute for Molecular Biology and Applied Ecology IME | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 4 | Germany | ||
5 | JPRN-jRCTs041180071 | 13/10/2016 | 07/03/2019 | T-ReX study | Tocilizumab treatment with Reducing and stopping methotreXate in patients with rheumatoid arthritis in stable low disease activity-state - T-ReX study | Rheumatoid arthritis | At week 0, the dosing frequency of MTX was decreased from weekly to biweekly without a change in dose, regardless of the initial dose. At week 12, MTX was discontinued if low disease activity was maintained. TCZ and csDMARDs other than MTX were continued at a stable dose and interval throughout the course of the study. Glucocorticoids were continued at a stable dose up to week 36, and allowed to taper after week 36. The use of oral analgesics (non-steroidal anti-inflammatory drugs, acetaminophen, pregabalin, and tramadol) was not prohibited during the study period. One or more of the following rescue treatments were performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request: changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX; increasing doses of or adding csDMARDs other than MTX or glucocorticoids; and administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine. | Kojima Toshihisa | NULL | Complete | >= 20age old | Not applicable | Both | 51 | N/A | 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 |
6 | NCT02264301 (ClinicalTrials.gov) | August 2014 | 3/10/2014 | Qingkailing Injection Versus Puerarin Injection on Withdrawal Rate of Corticosteroids in Patients With Active Rheumatoid Arthritis | The Effect of Qingkailing Injection on Corticosteroids Withdrawal Rate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Puerarin injection 400 mg;Drug: Qingkailing injection 40 ml | Chengdu PLA General Hospital | NULL | Enrolling by invitation | 18 Years | 75 Years | All | 150 | N/A | China |
7 | NCT02046603 (ClinicalTrials.gov) | March 4, 2014 | 24/1/2014 | A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic Agent | Open-Label, Phase IIIb Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab Monotherapy or Combination Therapy With Methotrexate (MTX) or Other Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Patients With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-Tumour Necrosis Factor (Anti-TNF) Biologic Agent | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: DMARDs;Drug: Oral Corticosteroids;Drug: Methotrexate | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 162 | Phase 3 | United Kingdom |
8 | NCT01724268 (ClinicalTrials.gov) | May 2012 | 7/11/2012 | Corticosteroids and Anti TNF in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient | Randomized Controlled Clinical Trial of Low Dose Corticosteroids vs Anti TNF Treatment in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient- a Pilot Study | RHEUMATOID ARTHRITIS | Drug: Pred + Meth;Drug: Anti TNF + Meth | Hamad Medical Corporation | NULL | Recruiting | 18 Years | N/A | Both | 80 | Phase 3 | Qatar |
9 | EUCTR2008-006064-11-LT (EUCTR) | 30/12/2009 | 19/10/2009 | An Efficacy and Safety Study of intravenous Golimumab in patients with Active Rheumatoid Arthritis (RA) despite treatment with methotrexate, non steroidal pain medications and/or corticosteroids | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Final Vialed Product (FVP) Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 564 | United States;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Mexico;Argentina;Malaysia;Poland;Australia;New Zealand;Korea, Republic of | |||
10 | NCT00720798 (ClinicalTrials.gov) | September 2005 | 22/7/2008 | An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies | Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core Studies | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: Disease-modifying anti-rheumatic drugs;Drug: Non-steroidal anti-inflammatory drugs;Drug: Oral corticosteroids | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 2067 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;China;Costa Rica;Czech Republic;Denmark;Finland;France;Germany;Hong Kong;Iceland;Israel;Italy;Lithuania;Mexico;Netherlands;Norway;Panama;Peru;Portugal;Puerto Rico;Russian Federation;Serbia;Slovenia;South Africa;Spain;Sweden;Switzerland;Thailand;United Kingdom |
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 | NCT00074438 (ClinicalTrials.gov) | June 2003 | 12/12/2003 | Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis | Randomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: methotrexate;Drug: rituximab;Drug: corticosteroids;Drug: placebo | Genentech, Inc. | Roche Pharma AG | Completed | 18 Years | 80 Years | Both | 465 | Phase 2 | 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 | NCT02953821 (ClinicalTrials.gov) | December 16, 2016 | 1/11/2016 | Acthar Gel for Active Systemic Lupus Erythematosus (SLE) | A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose Corticosteroids | Lupus Erythematosus, Systemic | Drug: Acthar Gel;Drug: Placebo Gel | Mallinckrodt | NULL | Completed | 18 Years | N/A | All | 172 | Phase 4 | United States;Argentina;Chile;Mexico;Peru;Colombia |
2 | JPRN-UMIN000025328 | 2015/12/05 | 25/12/2016 | A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV+/-V Lupus Nephritis | A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV+/-V Lupus Nephritis - Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis | systemic lupus erythematosus | Tacrolimus Mycophenolate Mofetil | The University of Hong Kong | NULL | Recruiting | 18years-old | 75years-old | Male and Female | 200 | Not selected | Japan,Asia(except Japan) |
3 | NCT00626197 (ClinicalTrials.gov) | February 2008 | 20/2/2008 | A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG) | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With WHO or ISN Class III or IV Nephritis Due to Systemic Lupus Erythematosus | Lupus Nephritis;Systemic Lupus Erythematosus | Drug: corticosteroids;Drug: cyclophosphamide;Drug: mycophenolate mofetil;Drug: ocrelizumab;Drug: placebo | Genentech, Inc. | Roche Pharma AG | Completed | 16 Years | N/A | All | 381 | Phase 3 | United States |
4 | NCT00430677 (ClinicalTrials.gov) | June 2007 | 1/2/2007 | Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis | A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Drug: Corticosteroids (prednisone or prednisolone);Drug: Abatacept;Drug: Mycophenolate mofetil (MMF) | Bristol-Myers Squibb | NULL | Terminated | 18 Years | N/A | All | 423 | Phase 2;Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;China;France;Hong Kong;India;Korea, Republic of;Mexico;Poland;Russian Federation;South Africa;Taiwan;Turkey;United Kingdom;Japan;Philippines;Puerto Rico |
5 | NCT00230035 (ClinicalTrials.gov) | September 2005 | 28/9/2005 | Lupus Immunosuppressive/Immunomodulatory Therapy or Stem Cell Transplant (LIST) | A Randomized, Open Label, Phase II Multicenter Study of Non-Myeloablative Autologous Transplantation With Auto-CD34+HPC Versus Currently Available Immunosuppressive/Immunomodulatory Therapy for Treatment of Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Procedure: Leukapheresis;Procedure: Non-myeloablative high dose immunosuppressive therapy conditioning (HDIT);Procedure: Autologous CD34+HPC transplantation (HSCT);Procedure: Plasmapheresis;Drug: Rabbit anti-thymocyte globulin;Drug: Methylprednisolone;Drug: Growth colony stimulating factor (G-CSF);Drug: Corticosteroids;Drug: Mycophenolate mofetil;Drug: Azathioprine;Drug: Intravenous immunoglobulin;Drug: Methotrexate;Drug: Rituximab;Drug: Leflunomide | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Withdrawn | 18 Years | 60 Years | Both | 0 | Phase 2 | 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 | NCT00799773 (ClinicalTrials.gov) | April 2009 | 26/11/2008 | Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP) | STAR - Study of TTP and Rituximab, A Randomized Clinical Trial | Thrombotic Thrombocytopenic Purpura | Drug: Rituximab;Procedure: Plasma exchange;Drug: Corticosteroids | New England Research Institutes | National Heart, Lung, and Blood Institute (NHLBI);Genentech, Inc. | Terminated | 12 Years | N/A | All | 3 | Phase 3 | United States |
2 | NCT00713193 (ClinicalTrials.gov) | November 2007 | 9/7/2008 | Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in Thrombotic Thrombocytopenic Purpura (TTP) | A Multi-Center, Randomized Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in the Initial Therapy of Thrombotic Thrombocytopenic Purpura (TTP) | Thrombotic Thrombocytopenic Purpura | Drug: Cyclosporine;Drug: Prednisone | Ohio State University | Food and Drug Administration (FDA) | Completed | 18 Years | N/A | All | 16 | Phase 3 | 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 | NCT03942861 (ClinicalTrials.gov) | February 21, 2019 | 25/4/2019 | Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol. | Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol. | Ulcerative Colitis;Ultrasound Therapy; Complications | Drug: Solu-Medrol | Copenhagen University Hospital at Herlev | NULL | Recruiting | 18 Years | 70 Years | All | 50 | Denmark | |
2 | EUCTR2017-000937-30-AT (EUCTR) | 22/02/2018 | 03/01/2018 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Hungary;Spain;Poland;Belgium;Austria;Germany | ||
3 | EUCTR2017-000937-30-PL (EUCTR) | 13/12/2017 | 25/09/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Hungary;Spain;Belgium;Poland;Austria;Germany | ||
4 | EUCTR2017-000937-30-ES (EUCTR) | 27/11/2017 | 10/10/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Hungary;Poland;Belgium;Spain;Austria;Germany | |||
5 | EUCTR2017-000937-30-FR (EUCTR) | 07/11/2017 | 19/09/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Hungary;Spain;Poland;Belgium;Austria;Germany | ||
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 | EUCTR2016-001170-15-ES (EUCTR) | 19/10/2017 | 02/08/2017 | Intravenous corticosteroids in moderate ulcerative colitis | Efficacy of high-dose corticosteroid pulses added to conventional oral corticosteroid course in comparison with monotherapy oral corticosteroid course for moderate flares of ulcerative colitis: a randomized multicentre clinical trial - CECUM | Moderate flares of Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Urbason INN or Proposed INN: methylprednisolone Other descriptive name: METHYLPREDNISOLONE SODIUM HEMISUCCINATE | GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis ulcerosa) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 4 | Spain | ||
7 | EUCTR2017-000937-30-DE (EUCTR) | 10/10/2017 | 25/09/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | ABIVAX | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Hungary;Spain;Poland;Belgium;Austria;Germany | |||
8 | NCT03093259 (ClinicalTrials.gov) | October 1, 2017 | 17/3/2017 | ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis | Phase IIa Study to Evaluate the Safety and Efficacy of ABX464 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Immunomodulators, Anti-TNFa, Vedolizumab and/or Corticosteroids | Ulcerative Colitis | Drug: ABX464;Drug: Placebo oral capsule | Abivax S.A. | NULL | Completed | 18 Years | 70 Years | All | 32 | Phase 2 | Belgium |
9 | EUCTR2017-000937-30-BE (EUCTR) | 29/09/2017 | 03/08/2017 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 | ABIVAX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Hungary;Spain;Poland;Belgium;Austria;Germany | ||
10 | NCT02425852 (ClinicalTrials.gov) | December 2016 | 21/4/2015 | A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis | A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe Colitis | Ulcerative Colitis | Drug: Azathioprine;Drug: Infliximab;Drug: Prednisolone;Drug: Hydrocortisone | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | NULL | Recruiting | 18 Years | N/A | All | 146 | Phase 4 | France |
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 | NCT02665845 (ClinicalTrials.gov) | June 13, 2016 | 25/1/2016 | Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone (for Ulcerative Colitis). | Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis: A Protocol of a Multi-center Prospective Randomized Investigator Blinded Trial. | Ulcerative Colitis | Drug: 5-ASA;Drug: Corticosteroids | Centre Hospitalier Universitaire de Saint Etienne | NULL | Recruiting | 18 Years | N/A | All | 160 | Phase 3 | France;Greece;Israel;Italy;Korea, Republic of;Serbia |
12 | NCT04564638 (ClinicalTrials.gov) | March 1, 2015 | 11/9/2020 | Long-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous Corticosteroids | Long-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous Corticosteroids | Ulcerative Colitis | Drug: Corticosteroid | Tampere University Hospital | NULL | Completed | N/A | N/A | All | 217 | NULL | |
13 | NCT02033408 (ClinicalTrials.gov) | January 2014 | 3/12/2013 | Manipulating the Microbiome in IBD by Antibiotics and FMT | Manipulating the Microbiome in IBD by Antibiotics and Fecal Microbiota Transplantation (FMT): a Randomized Controlled Trial | Exacerbation of Ulcerative Colitis;Ulcerative Colitis, Active Severe;Crohn's Colitis | Drug: AB (antibiotics);Drug: CS (corticosteroids) Only | Shaare Zedek Medical Center | NULL | Active, not recruiting | 2 Years | 75 Years | All | 28 | Phase 4 | Canada;Finland;Israel;Italy;Poland;Spain |
14 | NCT01941589 (ClinicalTrials.gov) | September 2013 | 30/8/2013 | Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis | Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis. | Ulcerative Colitis | Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone;Drug: corticosteroids only | Sheba Medical Center | NULL | Recruiting | 18 Years | N/A | All | 160 | Phase 4 | China;France;Greece;Israel;Italy;Korea, Republic of;Serbia |
15 | NCT02922374 (ClinicalTrials.gov) | January 2013 | 28/9/2016 | Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis | Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis: A Prospective Observational Study | Acute Severe Colitis (ASC) | Drug: corticosteroids | Jinling Hospital, China | NULL | Active, not recruiting | 18 Years | N/A | Both | 117 | Phase 1;Phase 2 | 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 |
16 | NCT01536535 (ClinicalTrials.gov) | July 10, 2012 | 16/2/2012 | Predicting Response to Standardized Pediatric Colitis Therapy | Multicenter Open-label Study Evaluating the Safety and Efficacy of Standardized Initial Therapy Using Either Mesalamine or Corticosteroids Then Mesalamine to Treat Children and Adolescents With Newly Diagnosed Ulcerative Colitis. | Ulcerative Colitis | Drug: Mesalazine;Drug: IV Corticosteroid;Drug: Oral Corticosteroids;Other: Additional Therapies;Procedure: Colectomy | Connecticut Children's Medical Center | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 4 Years | 17 Years | All | 431 | Phase 4 | United States;Canada |
17 | EUCTR2009-015077-12-GB (EUCTR) | 23/11/2009 | 17/09/2009 | The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia | The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia | chronic ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | University Hospital Birmingham NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 4 | United Kingdom | |||
18 | EUCTR2007-006692-37-GB (EUCTR) | 10/04/2008 | 25/01/2008 | The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit | The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit | IBDVit1 - Active Crohn's Disease IBDVit2 - Active Crohn's Disease IBDVit3 - Crohn's Disease in remission / Ulcerative Colitis in remission MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10045365;Term: Ulcerative colitis | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 4 | United Kingdom | |||
19 | EUCTR2006-004303-19-BE (EUCTR) | 08/06/2007 | 07/02/2007 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Czech Republic;United Kingdom;Belgium | |||
20 | EUCTR2006-004303-19-CZ (EUCTR) | 09/05/2007 | 20/02/2007 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 181 | United Kingdom;Czech Republic;Belgium | |||
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 |
21 | EUCTR2006-004303-19-SK (EUCTR) | 04/05/2007 | 08/03/2007 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 181 | Phase 2 | Czech Republic;Slovakia;Belgium;United Kingdom | ||
22 | EUCTR2006-004303-19-GB (EUCTR) | 25/04/2007 | 06/12/2006 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | Steroid-refractory ulcerative colitis MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Other descriptive name: Basiliximab | Cerimon Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | Czech Republic;Slovakia;Belgium;United Kingdom | ||
23 | NCT00430898 (ClinicalTrials.gov) | January 2007 | 31/1/2007 | Basiliximab in Moderate to Severe Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis | Ulcerative Colitis | Drug: Basiliximab | Cerimon Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | Both | 181 | Phase 2 | United States;Belgium;Czech Republic;India;Poland;Russian Federation;Slovakia;Ukraine;United Kingdom |
24 | NCT00269438 (ClinicalTrials.gov) | December 2005 | 22/12/2005 | New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis | Phase 3 Study to Establish the Efficacy and Safety of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium Dosed Twice Daily in Achieving Clinical Improvement in Subjects With Mildly to Moderately Active Ulcerative Colitis After 8 Weeks of Therapy | Ulcerative Colitis | Drug: 5 ASA, enemas, suppositories, corticosteroids | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | 80 Years | All | 225 | Phase 3 | United States |
25 | NCT00267306 (ClinicalTrials.gov) | January 2004 | 16/12/2005 | Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis | A Phase 1/2, Partially Randomized, Open-Label Study of Visilizumab in Patients With Severe Ulcerative Colitis Refractory to Intravenous Corticosteroids | Severe Ulcerative Colitis | Drug: Visilizumab | Facet Biotech | PDL BioPharma, Inc. | Completed | 16 Years | 70 Years | Both | 144 | Phase 1;Phase 2 | 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 |
26 | NCT00032305 (ClinicalTrials.gov) | March 2002 | 14/3/2002 | Research Study in Patients With Severe Ulcerative Colitis | A Phase I, Dose-Escalation, Pilot Study of Visilizumab in Patients With Severe Ulcerative Colitis That is Refractory to Corticosteroids | Ulcerative Colitis | Drug: Visilizumab | Facet Biotech | NULL | Completed | 18 Years | 70 Years | Both | 20 | Phase 2;Phase 3 | 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 | NCT00642460 (ClinicalTrials.gov) | May 2008 | 19/3/2008 | A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA) | A Randomized, Placebo-controlled Study to Evaluate the Effect of Tocilizumab on Disease Response in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA), With an Open-label Extension to Examine the Long Term Use of Tocilizumab | Juvenile Idiopathic Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: Placebo;Drug: Non-steroidal anti-inflammatory drugs (NSAIDs);Drug: methotrexate;Drug: corticosteroids | Hoffmann-La Roche | NULL | Completed | 2 Years | 17 Years | All | 112 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;Germany;Greece;Italy;Mexico;Netherlands;Norway;Poland;Slovakia;Spain;Sweden;United Kingdom;France |
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 | NCT00514982 (ClinicalTrials.gov) | August 7, 2007 | 9/8/2007 | Medical Treatment of Colitis in Patients With Hermansky-Pudlak Syndrome | An Observational Study of the Immunopathogenesis of and Response to Step-Up Inflammatory Bowel Disease Therapy for Hermansky-Pudlak Syndrome-Associated Colitis | Hermanski-Pudlak Syndrome;Colitis;Cytokines;Lymphocytes;Drug Evaluation | Drug: Mesalamine;Drug: Infliximab;Drug: Corticosteroids;Drug: 6-Mercaptopurine;Drug: Tacrolimus;Drug: Adalimumab | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | 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 | NCT00354198 (ClinicalTrials.gov) | August 2006 | 18/7/2006 | Efficacy of Pentoxifylline on Rapidly Progressive Glomerulonephritis | Clinical Efficacy of Combined Pentoxifylline and Conventional Immunosuppressive Regimens on Patients With Rapidly Progressive Glomerulonephritis | Glomerulonephritis | Drug: pentoxifylline;Drug: corticosteroids | National Taiwan University Hospital | National Science Council, Taiwan | Terminated | 20 Years | 80 Years | Both | 7 | Phase 3 | Taiwan |
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 | NCT00294684 (ClinicalTrials.gov) | November 2005 | 21/2/2006 | A Randomized, Double-Blinded, Placebo-Controlled Trial of Corticosteroid Therapy Following Portoenterostomy | A Randomized, Double-Blinded, Placebo-Controlled Trial of Corticosteroid Therapy Following Portoenterostomy in Infants With Biliary Atresia | Biliary Atresia | Drug: Corticosteroids;Drug: Placebo | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | N/A | 6 Months | All | 141 | N/A | United States |
2 | NCT00539565 (ClinicalTrials.gov) | January 2000 | 3/10/2007 | RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia. | Phase IIIb Study of Corticosteroids as Post-Operative Adjuvant Therapy in Biliary Atresia | Biliary Atresia | Drug: prednisolone;Drug: placebo | King's College Hospital NHS Trust | NULL | Enrolling by invitation | N/A | 100 Days | Both | 100 | Phase 3 | United Kingdom |
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 | NCT02797665 (ClinicalTrials.gov) | May 2016 | 6/6/2016 | Treatment of Obstructive Jaundice in Autoimmune Pancreatitis and/or Immunoglobulin G4-related Sclerosing Cholangitis by Corticosteroids | Autoimmune Pancreatitis;IgG4-related Sclerosing Cholangitis;Obstructive Jaundice | Drug: corticosteroids;Procedure: biliary stent | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | N/A | All | 30 | N/A | China |