C21 (DrugBank: -)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 51 | 全身性強皮症 | 2 |
| 85 | 特発性間質性肺炎 | 3 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04388176 (ClinicalTrials.gov) | January 3, 2020 | 11/5/2020 | Cold Challenge With C21 in RP | A Phase 2, Single-center, Randomised, Double-blind, Placebo-controlled, Cross-over Cold Challenge Study Investigating the Effect of C21 on Cold-induced Vasoconstriction in Subjects With Raynaud's Phenomenon (RP) Secondary to Systemic Sclerosis (SSc) | Raynaud Phenomenon;Systemic Sclerosis | Drug: C21;Drug: Placebo | Vicore Pharma AB | SGS Life Sciences, a division of SGS Belgium NV | Recruiting | 19 Years | 75 Years | All | 16 | Phase 2 | United Kingdom |
| 2 | EUCTR2019-003203-35-GB (EUCTR) | 13/12/2019 | 05/09/2019 | NA | A Phase 2, single-center, randomised, double-blind, placebo-controlled, cross-over, cold challenge study investigating the effect of C21 on cold-induced vasoconstriction in subjects with Raynaud’s Phenomenon (RP) secondary to systemic sclerosis (SSc) | Systemic sclerosis (SSc)Raynaud’s phenomenon (RP) MedDRA version: 20.0;Level: PT;Classification code 10037912;Term: Raynaud's phenomenon;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: NA Product Code: C21 INN or Proposed INN: NA Other descriptive name: 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt | Vicore Pharma AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 16 | Phase 2 | United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04533022 (ClinicalTrials.gov) | September 2020 | 26/8/2020 | Efficacy, Safety and Pharmacokinetics of C21 in Subjects With IPF | A Phase 2, Multi-Centre, Open-Label, Single-Arm Trial Investigating the Safety, Efficacy and Pharmacokinetics of C21 in Subjects With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: C21 | Vicore Pharma AB | Orphan Reach | Not yet recruiting | 40 Years | N/A | All | 60 | Phase 2 | NULL |
| 2 | EUCTR2020-000822-24-GB (EUCTR) | 06/07/2020 | 03/04/2020 | To investigate the safety, effectiveness and fate of study drug C21 in people with chronic scarring lung disease characterised by a progressive and irreversible decline in lung function. | A Phase 2, Multi-Centre, Open-Label, Single-Arm Trial Investigating the Safety, Efficacy and Pharmacokinetics of C21 in Subjects with Idiopathic Pulmonary Fibrosis - C21 in IPF | Idiopathic Pulmonary Fibrosis MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: C21 INN or Proposed INN: C21 Other descriptive name: 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt | Vicore Pharma AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Ukraine;United Kingdom | ||
| 3 | EUCTR2017-004923-63-GB (EUCTR) | 10/07/2018 | 20/12/2017 | A study to test the safety, tolerability, and the effects of C21 in patients with Idiopathic Pulmonary Fibrosis (IPF) | A phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of C21 in patients with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Vicore Pharma AB | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Serbia;Poland;Bulgaria;United Kingdom |