96. クローン病 Crohn disease Clinical trials / Disease details


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 168 - 標的パスウェイ数 : 214

  
10 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2016-005199-90-SK
(EUCTR)
14/02/201914/02/2018Open Label Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. An Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects with Active Crohn’s Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study - RHB-104-04 and MAP (US2) Moderately to Severely Active 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: RHB-104
INN or Proposed INN: Clarithromycin
Other descriptive name: CLARITHROMYCIN
INN or Proposed INN: Rifabutin
Other descriptive name: RIFABUTIN
INN or Proposed INN: Clofazimine
Other descriptive name: CLOFAZIMINE
RedHill Biopharma Ltd.NULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Czech Republic;Slovakia;Canada;Poland;Australia;Israel;New Zealand
2NCT03009396
(ClinicalTrials.gov)
March 18, 201726/12/2016Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's DiseaseAn Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects With Active Crohn's Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 StudyCrohn DiseaseDrug: RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimineRedHill Biopharma LimitedNULLCompleted18 Years76 YearsAll54Phase 3United States;Canada;Czechia;Israel;New Zealand;Poland;Serbia
3EUCTR2015-001179-36-BG
(EUCTR)
14/03/201717/01/2017Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received.A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease. - RHB-104-01 Moderately to Severely Active 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: RHB-104
INN or Proposed INN: Clarithromycin
Other descriptive name: CLARITHROMYCIN
INN or Proposed INN: Rifabutin
Other descriptive name: RIFABUTIN
INN or Proposed INN: Clofazimine
Other descriptive name: CLOFAZIMINE
RedHill Biopharma Ltd.NULLNot Recruiting Female: yes
Male: yes
324 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand
4EUCTR2015-001179-36-CZ
(EUCTR)
30/01/201715/11/2016Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received.A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease. - RHB-104-01 Moderately to Severely Active 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: RHB-104
INN or Proposed INN: Clarithromycin
Other descriptive name: CLARITHROMYCIN
INN or Proposed INN: Rifabutin
Other descriptive name: RIFABUTIN
INN or Proposed INN: Clofazimine
Other descriptive name: CLOFAZIMINE
RedHill Biopharma Ltd.NULLNot Recruiting Female: yes
Male: yes
324 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand
5EUCTR2015-001179-36-SK
(EUCTR)
13/01/201721/11/2016Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received.A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease. - RHB-104-01 Moderately to Severely Active 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: RHB-104
INN or Proposed INN: Clarithromycin
Other descriptive name: CLARITHROMYCIN
INN or Proposed INN: Rifabutin
Other descriptive name: RIFABUTIN
INN or Proposed INN: Clofazimine
Other descriptive name: CLOFAZIMINE
RedHill Biopharma Ltd.NULLNot Recruiting Female: yes
Male: yes
324 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand
6EUCTR2014-004108-31-CZ
(EUCTR)
13/10/201502/06/2015Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received.A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately Active Crohn’s Disease - MAP EU Moderately Active Crohn's Disease
MedDRA version: 19.0;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: RHB-104
INN or Proposed INN: Clarithromycin
Other descriptive name: CLARITHROMYCIN
INN or Proposed INN: Rifabutin
Other descriptive name: RIFABUTIN
INN or Proposed INN: Clofazimine
Other descriptive name: CLOFAZIMINE
RedHill Biopharma Ltd.NULLNot RecruitingFemale: yes
Male: yes
360Phase 3United Kingdom;Hungary;Czech Republic;Ukraine;Ireland;Russian Federation
7EUCTR2014-004108-31-HU
(EUCTR)
27/08/201528/04/2015Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received.A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately Active Crohn’s Disease - MAP EU Moderately Active Crohn's Disease
MedDRA version: 18.0;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: RHB-104
INN or Proposed INN: Clarithromycin
Other descriptive name: CLARITHROMYCIN
INN or Proposed INN: Rifabutin
Other descriptive name: RIFABUTIN
INN or Proposed INN: Clofazimine
Other descriptive name: CLOFAZIMINE
RedHill Biopharma Ltd.NULLNot RecruitingFemale: yes
Male: yes
360Phase 3Czech Republic;Hungary;Slovakia;Belgium;Spain;Ukraine;Ireland;Russian Federation;Netherlands;Germany;United Kingdom
8EUCTR2015-001179-36-PL
(EUCTR)
24/07/201501/06/2015Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received.A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease Moderately to Severely Active 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: RHB-104
INN or Proposed INN: Clarithromycin
Other descriptive name: CLARITHROMYCIN
INN or Proposed INN: Rifabutin
Other descriptive name: RIFABUTIN
INN or Proposed INN: Clofazimine
Other descriptive name: CLOFAZIMINE
RedHill Biopharma Ltd.NULLNot Recruiting Female: yes
Male: yes
324 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand
9NCT00513552
(ClinicalTrials.gov)
July 20076/8/2007Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium ParatuberculosisTreatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium ParatuberculosisCrohn's DiseaseDrug: Rifabutin, Clarithromycin, and ClofazimineMedstar Health Research InstituteNULLWithdrawn18 Years90 YearsAll0Phase 4United States
10NCT00269386
(ClinicalTrials.gov)
April 200022/12/2005Clarithromycin in Active Crohn's DiseaseRandomised Controlled Trial of Clarithromycin in Active Crohn's DiseaseCrohn's DiseaseDrug: Clarithromycin;Drug: PlaceboRoyal Liverpool University HospitalAbbottCompleted18 YearsN/ABoth44Phase 3United Kingdom