Gc1008 (DrugBank: GC1008)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 85 | 特発性間質性肺炎 | 1 |
| 222 | 一次性ネフローゼ症候群 | 4 |
| 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 | NCT00125385 (ClinicalTrials.gov) | July 2005 | 29/7/2005 | Study of GC1008 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Phase I, Open-Label, Multi-Center, Single-Dose, Dose-Escalating, Safety, Tolerability and Pharmacokinetic of GC1008 in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Biological: GC1008 | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | 79 Years | Both | 25 | Phase 1 | United States;Belgium |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2012-002365-35-DE (EUCTR) | 15/07/2013 | 11/03/2013 | A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS) | A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients with Steroid-Resistant Primary Focal Segmental Glomerulosclerosis | Focal segmental glomerulosclerosis MedDRA version: 14.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify | Product Name: Fresolimumab Product Code: GC1008 INN or Proposed INN: Fresolimumab Other descriptive name: GZ402669 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 125 | Phase 2 | France;United States;Brazil;Spain;Germany;Italy | ||
| 2 | EUCTR2012-002365-35-IT (EUCTR) | 22/05/2013 | 20/03/2013 | A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS) | A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients with Steroid-Resistant Primary Focal Segmental Glomerulosclerosis | Focal segmental glomerulosclerosis MedDRA version: 15.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify | Product Name: Fresolimumab Product Code: GC1008 INN or Proposed INN: Fresolimumab Other descriptive name: GZ402669 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 125 | Phase 2 | France;United States;Brazil;Spain;Germany;Italy | ||
| 3 | EUCTR2012-002365-35-ES (EUCTR) | 19/04/2013 | 09/04/2013 | A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS) | A Phase 2, Multicenter, Double-Blind, Parallel Dosing, Randomized Study of Fresolimumab or Placebo in Patients with Steroid-Resistant Primary Focal Segmental Glomerulosclerosis | Focal segmental glomerulosclerosis MedDRA version: 14.1;Level: PT;Classification code 10067757;Term: Focal segmental glomerulosclerosis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Not possible to specify | Product Name: Fresolimumab Product Code: GC1008 INN or Proposed INN: Fresolimumab Other descriptive name: GZ402669 | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 125 | Phase 2 | France;United States;Brazil;Spain;Germany;Italy | ||
| 4 | NCT00464321 (ClinicalTrials.gov) | May 2007 | 20/4/2007 | Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGS | A Phase I, Multicentre, Open-label, Dose-escalating Study of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic Focal Segmental Glomerulosclerosis (FSGS) | Focal Segmental Glomerulosclerosis | Biological: GC1008 | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | N/A | Both | 16 | Phase 1 | United States;Germany;Italy;United Kingdom |