Arginine (DrugBank: Arginine)
9 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 1 |
| 67 | 多発性嚢胞腎 | 1 |
| 78 | 下垂体前葉機能低下症 | 9 |
| 96 | クローン病 | 10 |
| 97 | 潰瘍性大腸炎 | 38 |
| 113 | 筋ジストロフィー | 2 |
| 210 | 単心室症 | 1 |
| 251 | 尿素サイクル異常症 | 9 |
| 299 | 嚢胞性線維症 | 2 |
| 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 | NCT04535427 (ClinicalTrials.gov) | January 1, 2021 | 22/8/2020 | Role of L-Arginine Supplementation in the Treatment of Rheumatoid Arthritis | Role of L-Arginine Supplementation in the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: L-arginine;Drug: Placebo | RenJi Hospital | NULL | Not yet recruiting | 18 Years | 45 Years | All | 144 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00345137 (ClinicalTrials.gov) | May 2006 | 24/6/2006 | Effects of Systemic NO-Inhibition on Renal Hemodynamics in Patiens With Polycystic Kidney Disease and Chronic Glomerulonephritis | Phase 1 Study of Systemic Effects of Ng-Monomethyl-L-Arginine on Renal Hemodynamics in Patients With Polycystic Kidney Disease and Chronic Glomerulonephritis | ADPKD;Glomerulonephritis | Drug: Ng-monomethyl-L-arginine (drug) | Regional Hospital Holstebro | NULL | Completed | 20 Years | 60 Years | Both | 75 | Phase 1 | 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 | NCT04465565 (ClinicalTrials.gov) | December 2020 | 3/7/2020 | Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test | Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test- Randomized, 2 Arms, Controlled Study | Growth Hormone Deficiency | Procedure: 9% Sodium Chloride (NaCl) IV | Rabin Medical Center | NULL | Not yet recruiting | 7 Years | 16 Years | All | 120 | N/A | Israel |
| 2 | JPRN-UMIN000027260 | 2017/02/06 | 07/05/2017 | Analysis of Airway Inflammatory state alteration after intravenous L-Arginine loading | Children who are required growth hormone (GH) stimulation tests to diagnose GH deficiency. These are children whose heights are two standard deviations (SD) below the mean for age and sex, and/or whose growth velocities are 1.5 SD below the mean for age and sex over 2 years' follow-up, or whose pediatric endocrinologists order growth hormone (GH) stimulation test for another reasons. | Dosing 500mg/kg L-arginine (maximal dose 30g) intravenous drip in 30minutes | Osaka City University Graduate School of Medicine | NULL | 2years-old | 15years-old | Male and Female | 15 | Not selected | Japan | ||
| 3 | NCT00324064 (ClinicalTrials.gov) | July 2007 | 8/5/2006 | Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing | Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing | Growth Hormone Deficiency | Procedure: GHRH/arginine stimulation testing | Children's Mercy Hospital Kansas City | NULL | Completed | 5 Years | 40 Years | Both | 90 | N/A | United States |
| 4 | NCT00720902 (ClinicalTrials.gov) | February 2007 | 16/6/2008 | Adult Growth Hormone Deficiency and Cardiovascular Risk | Assessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary Adenomas | Growth Hormone Deficiency | Procedure: Blood draws;Drug: Growth hormone releasing hormone (GHRH) and arginine;Procedure: Carotid ultrasound;Procedure: MRI;Procedure: Endothelial cell biopsy | Columbia University | NULL | Terminated | 19 Years | 65 Years | Both | 8 | N/A | United States |
| 5 | NCT00468624 (ClinicalTrials.gov) | December 2004 | 2/5/2007 | Effect of Pegvisomant on GH/IGF-I Relationship in GHD | A Study of the Relationship Between Serum Growth Hormone (GH) and Insulin-Like Growth Factor One (IGF-I) in Patients With Severe Adult Growth Hormone Deficiency (AGHD) | Severe Adult Growth Hormone Deficiency | Drug: pegvisomant/placebo loading dose 80mg sc, thereafter 20mg daily for 2 weeks;Procedure: GH sampling - every 20 min over 24 hours after each limb (pegvisomant/placebo);Procedure: blood sampling before and after pegvisomant/placebo;Procedure: arginine stimulation test after each limb | Christie Hospital NHS Foundation Trust | NULL | Terminated | 18 Years | 70 Years | Both | N/A | 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 |
| 6 | NCT01060488 (ClinicalTrials.gov) | January 2004 | 29/1/2010 | Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency | A Phase III, Multicentric, Open-label, Randomised, Comparative, Parallel Group Study of (GHRH + Arginine) Combination Test vs. Insulin Tolerance Test (ITT) in the Diagnosis of Adult Growth Hormone Deficiency (AGHD) | Growth Hormone Deficiency | Other: GHRH+Arg, GHRH+Arg, ITT;Other: ITT, ITT, GHRH+Arg. | Merck KGaA | NULL | Completed | 18 Years | 60 Years | Both | 69 | Phase 3 | France |
| 7 | NCT03018886 (ClinicalTrials.gov) | May 2001 | 6/1/2017 | Diagnosing Adult Growth Hormone Deficiency | Diagnosis of Adult Growth Hormone Deficiency With Growth Hormone Releasing Hormone Plus Arginine Stimulation Test | Growth Hormone Deficiency | Other: GHRH plus arginine test | Helsinki University Central Hospital | NULL | Completed | 16 Years | 80 Years | All | 160 | N/A | Finland |
| 8 | NCT00134420 (ClinicalTrials.gov) | February 2001 | 22/8/2005 | Growth Hormone and Chromosome 18q- and Abnormal Growth | Growth Hormone Trial for Children With 18q- and Abnormal Growth | Loss of Chromosome 18q;Growth Hormone Deficiency | Drug: Nutropin AQ;Procedure: Arginine and Clonidine Stimulation Testing;Procedure: Growth Factors Laboratory Testing;Procedure: Neuropsychological Testing | The University of Texas Health Science Center at San Antonio | South Texas Veterans Health Care System;Genentech, Inc. | Completed | N/A | 18 Years | Both | 20 | Phase 3 | United States |
| 9 | EUCTR2010-018781-23-NL (EUCTR) | 17/02/2010 | Diagnose of GH-deficiency: comparing the dietary-protein test with conventional Growth Hormone Stimulation Tests | Diagnose of GH-deficiency: comparing the dietary-protein test with conventional Growth Hormone Stimulation Tests | To investigate if there is a correlation between the peak GH concentrations after ingestion of gelatin protein and the peak GH concentrations after the two standard tests (GHST) in order to discriminate growth hormone deficiency (GHD) and non-GHD. To investigate the differences in coefficient of variation between the different tests (arginine, clonidine, protein). To investigate the frequency of side effects in the different tests (arginine, clonidine, protein). MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: Gelatin Product Code: 3 Product Name: Arginin Product Code: 1 Trade Name: Clonidine HCl CF 0,150 mg, tabletten Product Name: Clonidine Product Code: 2 INN or Proposed INN: Clonidin Other descriptive name: CLONIDINE HYDROCHLORIDE | Top Institute Food and Nutrition | NULL | NA | Female: yes Male: yes | Netherlands |
| 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 | EUCTR2019-002895-14-GB (EUCTR) | 05/08/2020 | 02/01/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - CULTIVATE APD334-202 | 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 Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan;Slovenia;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;Netherlands;China | ||
| 2 | EUCTR2019-002895-14-NL (EUCTR) | 05/08/2020 | 23/01/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely 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 Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;Netherlands;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 3 | EUCTR2019-002895-14-PT (EUCTR) | 27/07/2020 | 06/01/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely 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 Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 2 | Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Bulgaria;Georgia;Germany;Norway;Japan | ||
| 4 | EUCTR2019-002895-14-BG (EUCTR) | 21/05/2020 | 23/01/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely 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 Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 5 | EUCTR2019-002895-14-ES (EUCTR) | 14/05/2020 | 15/05/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely 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 Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 2 | Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;Netherlands;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;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 | EUCTR2019-002895-14-NO (EUCTR) | 04/05/2020 | 20/12/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely 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 Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;Belarus;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 7 | EUCTR2019-002895-14-FR (EUCTR) | 17/02/2020 | 08/01/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely 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 Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States | ||
| 8 | EUCTR2019-002895-14-LT (EUCTR) | 13/02/2020 | 19/12/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely 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 Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 9 | EUCTR2019-002895-14-HU (EUCTR) | 03/02/2020 | 04/02/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely 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 Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Switzerland;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 10 | EUCTR2019-002895-14-CZ (EUCTR) | 09/01/2020 | 09/01/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely 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 Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;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 | EUCTR2018-003986-33-PT (EUCTR) | 06/07/2020 | 28/10/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Belarus;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 2 | EUCTR2018-003987-29-FR (EUCTR) | 11/06/2020 | 12/09/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 3 | EUCTR2018-003987-29-AT (EUCTR) | 15/04/2020 | 09/10/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 4 | EUCTR2018-003986-33-AT (EUCTR) | 07/04/2020 | 20/09/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 5 | EUCTR2018-003987-29-PT (EUCTR) | 02/03/2020 | 28/10/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | Germany;Japan;Georgia;United States;Serbia;Belarus;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria | ||
| 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 | EUCTR2018-003986-33-DK (EUCTR) | 28/02/2020 | 02/10/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | Moldova, Republic of;Serbia;Portugal;United States;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany | ||
| 7 | EUCTR2018-003986-33-GB (EUCTR) | 24/02/2020 | 17/09/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 8 | EUCTR2018-003987-29-BG (EUCTR) | 17/02/2020 | 23/10/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 9 | EUCTR2018-003986-33-BG (EUCTR) | 11/02/2020 | 23/10/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 10 | EUCTR2018-003986-33-LV (EUCTR) | 24/01/2020 | 01/11/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | South Africa;Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;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 |
| 11 | EUCTR2018-003987-29-DE (EUCTR) | 23/01/2020 | 30/09/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 12 | EUCTR2018-003986-33-FR (EUCTR) | 14/01/2020 | 20/09/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 13 | EUCTR2018-003986-33-LT (EUCTR) | 31/12/2019 | 08/10/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 14 | EUCTR2018-003987-29-DK (EUCTR) | 20/11/2019 | 02/10/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 15 | EUCTR2018-003987-29-LT (EUCTR) | 14/11/2019 | 06/11/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | United States;Serbia;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;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 | EUCTR2018-003986-33-HR (EUCTR) | 08/11/2019 | 17/01/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 17 | EUCTR2018-003987-29-LV (EUCTR) | 07/11/2019 | 16/09/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Lithuania;Turkey;Austria;United Kingdom | ||
| 18 | EUCTR2018-003987-29-HU (EUCTR) | 07/11/2019 | 17/09/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 19 | EUCTR2018-003986-33-HU (EUCTR) | 07/11/2019 | 08/11/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany | ||
| 20 | EUCTR2018-003985-15-ES (EUCTR) | 21/10/2019 | 21/10/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 372 | Phase 3 | Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;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 |
| 21 | EUCTR2018-003986-33-BE (EUCTR) | 14/10/2019 | 15/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 22 | EUCTR2018-003987-29-NL (EUCTR) | 07/10/2019 | 22/08/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 23 | EUCTR2018-003986-33-NL (EUCTR) | 03/10/2019 | 22/08/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 24 | EUCTR2018-003987-29-HR (EUCTR) | 02/10/2019 | 20/01/2020 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 25 | EUCTR2018-003985-15-BG (EUCTR) | 27/09/2019 | 12/08/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 372 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;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 |
| 26 | EUCTR2018-003985-15-DK (EUCTR) | 27/09/2019 | 24/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 372 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 27 | EUCTR2018-003985-15-NL (EUCTR) | 18/09/2019 | 09/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 372 | Phase 3 | Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 28 | EUCTR2018-003987-29-BE (EUCTR) | 16/09/2019 | 01/07/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | United States;Serbia;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 29 | EUCTR2018-003985-15-LT (EUCTR) | 27/08/2019 | 10/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 372 | Phase 3 | United States;Serbia;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 30 | EUCTR2018-003985-15-HR (EUCTR) | 14/08/2019 | 24/12/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 372 | Phase 3 | Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey | ||
| 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 |
| 31 | EUCTR2018-003986-33-SK (EUCTR) | 01/07/2019 | 02/05/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 32 | EUCTR2018-003987-29-SK (EUCTR) | 25/06/2019 | 15/04/2019 | An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC OLE | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 702 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | ||
| 33 | EUCTR2018-003985-15-SK (EUCTR) | 21/06/2019 | 16/04/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 372 | Phase 3 | Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand | ||
| 34 | EUCTR2018-003985-15-PL (EUCTR) | 02/08/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | NA | Female: yes Male: yes | 372 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | |||
| 35 | EUCTR2018-003985-15-DE (EUCTR) | 01/07/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | NA | Female: yes Male: yes | 372 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;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 |
| 36 | EUCTR2018-003986-33-DE (EUCTR) | 19/09/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan | |||
| 37 | EUCTR2018-003986-33-PL (EUCTR) | 15/11/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 330 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany | |||
| 38 | EUCTR2018-003985-15-BE (EUCTR) | 08/05/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | NA | Female: yes Male: yes | 372 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;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 | NCT01388764 (ClinicalTrials.gov) | January 2012 | 5/7/2011 | Safety, Tolerability and Effects of L-Arginine in Boys With Dystrophinopathy on Corticosteroids | Pilot Study: To Assess the Safety, Tolerability and Effects of L-Arginine on Muscles in Boys With Dystrophinopathy on Corticosteroids | Dystrophinopathy;Duchenne Muscular Dystrophy;Becker's Muscular Dystrophy | Drug: L-arginine | Massachusetts General Hospital | NULL | Completed | 7 Years | 11 Years | Male | 7 | Phase 1 | United States |
| 2 | NCT02516085 (ClinicalTrials.gov) | January 2012 | 3/8/2015 | Improved Muscle Function in Duchenne Muscular Dystrophy Through L-Arginine and Metformin | Duchenne Muscular Dystrophy | Drug: Metformin;Drug: L-Arginine | University Hospital, Basel, Switzerland | NULL | Completed | 7 Years | 10 Years | Both | 5 | Phase 1 | 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 | NCT03088345 (ClinicalTrials.gov) | March 6, 2017 | 28/2/2017 | Early Use of Vasopressin in Post-Fontan Management | Use of Arginine Vasopressin in Early Postoperative Management After Fontan Palliation | Circulatory Perfusion Disorder;Congenital Heart Disease;Single-ventricle | Drug: Vasopressin, Arginine;Drug: Placebo | Medical College of Wisconsin | NULL | Completed | N/A | 18 Years | All | 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 | EUCTR2014-000650-11-ES (EUCTR) | 13/04/2015 | 20/10/2014 | HEP002 is a clinical study designed for paediatric patients with urea cycle disorders (UCD). UCD patients will receive several infusions of HepaStem. The efficacy as well as the safety of the medicinal product will be assessed during the year following infusions. | A prospective, open label, multi-country, multicenter, efficacy and safety study of several infusions of Promethera HepaStem in Urea Cycle Disorders pediatric patients | The urea cycle disorders are inborn errors of metabolism that affect the transfer of nitrogen into urea. There are eight disorders: N-Acetylglutamate synthase deficiency, Carbamoyl phosphate synthetase I deficiency, Ornithine transcarbamylase deficiency, citrullinemia type I, argininosuccinic aciduria, argininemia, HHH syndrme and citrullinemia type II.Mutations in each of the enzymes have been identified, resulting in failed production of urea, the end product of the urea cycle. MedDRA version: 18.0;Level: LLT;Classification code 10013373;Term: Disorders of urea cycle metabolism;System Organ Class: 100000004861;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: HepaStem INN or Proposed INN: Celulas hepatocitos troncales adultas alogenicas de higado expandidas | Promethera Biosciences | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Belgium;Spain | |||
| 2 | EUCTR2013-001045-14-GB (EUCTR) | 30/07/2014 | 28/04/2014 | A long-term safety follow-up study of patients having received infusions of HepaStem. | SAF 001: A long-term safety follow-up study of patients having received infusions of HepaStem. - SAF001 | Crigler-Najjar syndrome is associated with a complete or partial hepatic deficit of bilirubin glucuronosyltransferase activity and is apparent during the neonatal period by intense jaundice. The UCD are inborn errors of metabolism that affect the transfer of nitrogen into urea. There are 8 disorders: N-Acetylglutamate synthase deficiency, Carbamoyl phosphate synthetase I deficiency, Ornithine transcarbamylase deficiency, citrullinemia I&II, argininosuccinic aciduria, HHH syndrome & argininemia MedDRA version: 19.0;Level: LLT;Classification code 10021601;Term: Inborn error of metabolism NOS;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Promethera Biosciences | NULL | Not Recruiting | Female: yes Male: yes | 19 | Phase 1;Phase 2 | Portugal;Belgium;Italy;United Kingdom | |||
| 3 | EUCTR2013-001045-14-PT (EUCTR) | 04/04/2014 | 02/10/2013 | A clinical study for evaluating long-term safety of patients suffering from Urea Cycle disorders (UCD) or Crigler-Najjar Syndrome (CN) having received infusions of HepaStem. | SAF 001: A long-term safety follow-up study of patients suffering from Urea Cycle disorders (UCD) or Crigler-Najjar Syndrome (CN) having received infusions of HepaStem. - SAF001 | Crigler-Najjar syndrome is associated with a complete or partial hepatic deficit of bilirubin glucuronosyltransferase activity and is apparent during the neonatal period by intense jaundice. The UCD are inborn errors of metabolism that affect the transfer of nitrogen into urea. There are 8 disorders: N-Acetylglutamate synthase deficiency, Carbamoyl phosphate synthetase I deficiency, Ornithine transcarbamylase deficiency, citrullinemia I&II, argininosuccinic aciduria, HHH syndrome & argininemia MedDRA version: 16.0;Level: LLT;Classification code 10021601;Term: Inborn error of metabolism NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: HepaStem INN or Proposed INN: Heterologous Human Adult Liver-derived Progenitor Cells Other descriptive name: NA | Promethera Biosciences | NULL | Not Recruiting | Female: yes Male: yes | 21 | Phase 1;Phase 2 | Portugal;Belgium;Israel;United Kingdom;Italy | ||
| 4 | EUCTR2013-001045-14-IT (EUCTR) | 14/02/2014 | 31/12/2013 | A clinical study for evaluating long-term safety of patients having received infusions of HepaStem. | SAF 001: A long-term safety follow-up study of patients having received infusions of HepaStem. - SAF001 | Crigler-Najjar syndrome is associated with a complete or partial hepatic deficit of bilirubin glucuronosyltransferase activity and is apparent during the neonatal period by intense jaundice. The UCD are inborn errors of metabolism that affect the transfer of nitrogen into urea. Thereare 8 disorders: N-Acetylglutamate synthase deficiency, Carbamoyl phosphate synthetase I deficiency, Ornithine transcarbamylase deficiency, citrullinemia I&II, argininosuccinic aciduria, HHH syndrome & argininemia MedDRA version: 16.1;Level: LLT;Classification code 10021601;Term: Inborn error of metabolism NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: HepaStem INN or Proposed INN: Heterologous Human Adult Liver-derived Progenitor Cells Other descriptive name: NA | Promethera Biosciences | NULL | Not Recruiting | Female: yes Male: yes | 21 | Phase 1;Phase 2 | Portugal;Belgium;Israel;United Kingdom;Italy | ||
| 5 | EUCTR2013-001045-14-BE (EUCTR) | 22/04/2013 | 19/03/2013 | A clinical study for evaluating long-term safety of patients suffering from Urea Cycle disorders (UCD) or Crigler-Najjar Syndrome (CN) having received infusions of HepaStem. | SAF 001: A long-term safety follow-up study of patients suffering from Urea Cycle disorders (UCD) or Crigler-Najjar Syndrome (CN) having received infusions of HepaStem. - SAF001 | Crigler-Najjar syndrome is associated with a complete or partial hepatic deficit of bilirubin glucuronosyltransferase activity and is apparent during the neonatal period by intense jaundice. The urea cycle disorders are inborn errors of metabolism that affect the transfer of nitrogen into urea. There are six disorders: N-Acetylglutamate synthase deficiency, Carbamoyl phosphate synthetase I deficiency, Ornithine transcarbamylase deficiency, citrullinemia, argininosuccinic aciduria and argininemia MedDRA version: 15.1;Level: LLT;Classification code 10021601;Term: Inborn error of metabolism NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: HepaStem INN or Proposed INN: Heterologous Human Adult Liver-derived Progenitor Cells Other descriptive name: NA | Promethera Biosciences | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 1;Phase 2 | Portugal;Belgium;United Kingdom;Italy | ||
| 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 | EUCTR2011-004074-28-IT (EUCTR) | 19/12/2012 | 14/01/2013 | A phase I/II trial for evaluating both safety and preliminary efficacy of one cycle of Promethera Hepastem in Urea Cycle Disorders and Crigler-Najjar Syndrome patients | A prospective, open label, multicenter, partially randomized, safety study of one cycle of Promethera HepaStem in Urea Cycle Disorders and Crigler-Najjar Syndrome Patients - HEP 001 | Crigle-Najjar syndrome is associated with a complete or partial hepatic deficit of bilirubin glucoronosyltransferase activity and is apparent during the neonatal period by intense jaundice. The urea cycle disorders are inborn errors of metabolism that affect the transfer of nitrogen into urea. There are six desorders: N-Acetylglutamate synthase deficiency, Carbamoyl phosphate synthase I deficiency, Ornithine transcarbamylase deficiency, citrullinemia, argininosuccinic aciduria and argininemia. MedDRA version: 15.1;Level: LLT;Classification code 10013373;Term: Disorders of urea cycle metabolism;System Organ Class: 100000004861 MedDRA version: 15.1;Level: PT;Classification code 10011386;Term: Crigler-Najjar syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 15.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;Classification code 10021601;Term: Inborn error of metabolism NOS;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: Promethera HepaStem Product Code: HHALPC INN or Proposed INN: Heterologous Human Adult Liver-derived Progenitor Cells (HHALPC) | PROMETHERA BIOSCIENCES | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 1;Phase 2 | Belgium;United Kingdom;Italy | ||
| 7 | EUCTR2011-004074-28-GB (EUCTR) | 20/07/2012 | 28/09/2011 | A phase I/II trial for evaluating both safety and preliminary efficacy of one cycle of Promethera HepaStem® in Urea Cycle Disorders and Crigler-Najjar Syndrome patients | A prospective, open label, multicenter, randomized, safety and preliminary efficacy study of one cycle of Promethera HepaStem® in Urea Cycle Disorders and Crigler-Najjar Syndrome patients - UKHEP001 | Crigler-Najjar syndrome is associated with a complete or partial hepatic deficit of bilirubin glucuronosyltransferase activity and is apparent during the neonatal period by intense jaundice. The urea cycle disorders are inborn errors of metabolism that affect the transfer of nitrogen into urea. There are six disorders: N-Acetylglutamate synthase deficiency, Carbamoyl phosphate synthetase I deficiency, Ornithine transcarbamylase deficiency, citrullinemia, argininosuccinic aciduria and argininemia MedDRA version: 17.0;Level: LLT;Classification code 10021601;Term: Inborn error of metabolism NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: HepaStem INN or Proposed INN: Heterologous Human Adult Liver-derived Progenitor Cells Other descriptive name: NA | Promethera Biosciences | NULL | Not Recruiting | Female: yes Male: yes | 21 | Phase 1;Phase 2 | Belgium;Italy;United Kingdom | ||
| 8 | EUCTR2011-004074-28-BE (EUCTR) | 13/02/2012 | 21/02/2012 | A phase I/II trial for evaluating safety of one cycle of Promethera HepaStem in Urea Cycle Disorders and Crigler-Najjar Syndrome patients | HEP 001: A prospective, open label, multicenter, partially randomized, safety study of one cycle of Promethera HepaStem in Urea Cycle Disorders (UCD) and Crigler-Najjar Syndrome (CN) paediatric patients. - HEP 001 | Crigler-Najjar syndrome is associated with a complete or partial hepatic deficit of bilirubin glucuronosyltransferase activity and is apparent during the neonatal period by intense jaundice. The urea cycle disorders are inborn errors of metabolism that affect the transfer of nitrogen into urea. There are six disorders: N-Acetylglutamate synthase deficiency, Carbamoyl phosphate synthetase I deficiency, Ornithine transcarbamylase deficiency, citrullinemia, argininosuccinic aciduria and argininemia MedDRA version: 14.1;Level: LLT;Classification code 10021601;Term: Inborn error of metabolism NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: HepaStem INN or Proposed INN: Heterologous Human Adult Liver-derived Progenitor Cells Other descriptive name: NA | Promethera Biosciences | NULL | Not Recruiting | Female: yes Male: yes | 21 | Phase 1;Phase 2 | Belgium;Italy;United Kingdom | ||
| 9 | NCT00345605 (ClinicalTrials.gov) | February 2008 | 26/6/2006 | Arginine and Buphenyl in Patients With Argininosuccinic Aciduria (ASA), a Urea Cycle Disorder | A Randomized, Double-Blind, Crossover Study of Sodium Phenylbutyrate and Low-Dose Arginine Compared to High-Dose Arginine Alone on Liver Function, Ureagenesis and Subsequent Nitric Oxide Production in Patients With Argininosuccinic Aciduria | Argininosuccinic Aciduria;Amino Acid Metabolism, Inborn Errors;Urea Cycle Disorders | Drug: Sodium Phenylbutyrate;Drug: Arginine | Brendan Lee | Office of Rare Diseases (ORD);Rare Diseases Clinical Research Network;Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | 5 Years | N/A | All | 12 | 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 | NCT01852448 (ClinicalTrials.gov) | May 2013 | 9/5/2013 | Genetics of Insulin and Incretins in Cystic Fibrosis | Evaluation of the Enteroinsular Axis in Cystic Fibrosis | Cystic Fibrosis | Genetic: Blood or Saliva Sample Collection;Other: Glucose -potentiated arginine (GPA) stimulation tests | Children's Hospital of Philadelphia | University of Pennsylvania | Active, not recruiting | 2 Years | N/A | All | 350 | United States | |
| 2 | NCT00405665 (ClinicalTrials.gov) | November 2006 | 28/11/2006 | The Short Term Safety and Efficacy of Inhaled L-arginine in Patients With Cystic Fibrosis | Pilot Study of the Short Term Safety and Efficacy of Inhaled L-arginine in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: L-arginine | The Hospital for Sick Children | NULL | Completed | 14 Years | N/A | Both | 20 | Phase 2 | Canada |