Fg-3019 (DrugBank: -)
3 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 | 7 |
| 113 | 筋ジストロフィー | 7 |
| 222 | 一次性ネフローゼ症候群 | 1 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2020-000697-22-DE (EUCTR) | 13/10/2020 | 05/08/2020 | A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis. | Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (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] - Skin and Connective Tissue Diseases [C17] | Product Name: Pamrevlumab Product Code: FG-3019 INN or Proposed INN: PAMREVLUMAB | FibroGen, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Phase 3 | Serbia;Spain;Ukraine;Lebanon;Ireland;Colombia;United Kingdom;Italy;India;France;Czech Republic;Hungary;Mexico;Poland;Belgium;Brazil;Dominican Republic;Peru;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany | ||
| 2 | EUCTR2020-000697-22-DK (EUCTR) | 13/10/2020 | 14/08/2020 | A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis. | Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (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] - Skin and Connective Tissue Diseases [C17] | Product Name: Pamrevlumab Product Code: FG-3019 INN or Proposed INN: PAMREVLUMAB | FibroGen, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Phase 3 | Serbia;Spain;Ukraine;Ireland;Lebanon;Colombia;United Kingdom;Italy;India;France;Czech Republic;Hungary;Mexico;Poland;Brazil;Dominican Republic;Peru;Denmark;Georgia;Netherlands;Germany | ||
| 3 | EUCTR2020-000697-22-HU (EUCTR) | 08/07/2020 | 22/05/2020 | A study to compare the use of Pamrevlumab with Placebo in patients with Idiopathic Pulmonary Fibrosis. | Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (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] - Skin and Connective Tissue Diseases [C17] | Product Name: Pamrevlumab Product Code: FG-3019 INN or Proposed INN: PAMREVLUMAB | FibroGen, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 340 | Phase 3 | Serbia;Spain;Ukraine;Lebanon;Ireland;Colombia;Italy;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Poland;Belgium;Brazil;Dominican Republic;Peru;Denmark;Bulgaria;Georgia;Norway;Netherlands;Germany | ||
| 4 | EUCTR2014-005658-20-BG (EUCTR) | 23/02/2016 | 18/12/2015 | FG-3019 treatment in Idiopathic Pulmonary Fibrosis (IPF) patients. | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients with Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;Level: HLT;Classification code 10033979;Term: Parenchymal lung disorders NEC;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: FG-3019 10mg/mL in 10 mL vials Product Code: FG-3019 INN or Proposed INN: Pamrevlumab | FibroGen, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 2 | United States;Canada;Australia;South Africa;Bulgaria;New Zealand;India | ||
| 5 | NCT01890265 (ClinicalTrials.gov) | July 30, 2013 | 24/6/2013 | Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: Pamrevlumab;Drug: Placebo;Drug: Sub-Study: Pirfenidone;Drug: Sub-Study: Nintedanib | FibroGen | NULL | Completed | 40 Years | 80 Years | All | 160 | Phase 2 | United States;Australia;Bulgaria;Canada;India;New Zealand;South Africa |
| 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 | NCT01262001 (ClinicalTrials.gov) | March 2011 | 15/12/2010 | Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis | A Phase 2, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: FG-3019 | FibroGen | NULL | Completed | 35 Years | 80 Years | All | 90 | Phase 2 | United States |
| 7 | NCT00074698 (ClinicalTrials.gov) | September 1994 | 18/12/2003 | Safety and Tolerability Study of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis | A Phase 1 Study of the Safety, Pharmacokinetics, and Biologic Activity of Escalating Doses of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: FG-3019 | FibroGen | NULL | Completed | 21 Years | 80 Years | Both | 27 | Phase 1 | 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 | EUCTR2020-000698-26-GB (EUCTR) | 16/12/2020 | 14/10/2020 | Evaluation of Pamrevlumab for the Treatment of Male Patients Affected by Non-ambulatory Duchenne Muscular Dystrophy and just Treated with Corticosteroids | A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD) | Non-ambulatory Duchenne Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Pamrevlumab Product Code: FG-3019 INN or Proposed INN: PAMREVLUMAB | FibroGen, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 90 | Phase 3 | United States;Slovakia;Spain;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Belgium;Australia;Netherlands | ||
| 2 | NCT04632940 (ClinicalTrials.gov) | December 2020 | 12/11/2020 | A Phase 3 Trial of Pamrevlumab (FG-3019) or Placebo in Combination With Systemic Corticosteroids, in Ambulatory Subjects With Duchenne Muscular Dystrophy (DMD) | A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination With Systemic Corticosteroids in Ambulatory Subjects With Duchenne Muscular Dystrophy (DMD) | Duchenne Muscular Dystrophy | Drug: Pamrevlumab;Drug: Placebo | FibroGen | NULL | Not yet recruiting | 6 Years | 11 Years | Male | 70 | Phase 3 | NULL |
| 3 | NCT04371666 (ClinicalTrials.gov) | July 30, 2020 | 29/4/2020 | A Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids, in Subjects With Non-ambulatory Duchenne Muscular Dystrophy (DMD) | A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination With Systemic Corticosteroids in Subjects With Non-ambulatory Duchenne Muscular Dystrophy (DMD) | Duchenne Muscular Dystrophy | Drug: Pamrevlumab;Drug: Placebo | FibroGen | NULL | Recruiting | 12 Years | N/A | Male | 90 | Phase 3 | United States |
| 4 | NCT02606136 (ClinicalTrials.gov) | November 30, 2015 | 4/11/2015 | Trial of Pamrevlumab (FG-3019), in Non-Ambulatory Subjects With Duchenne Muscular Dystrophy (DMD) | Trial of Pamrevlumab (FG-3019), a Monoclonal Antibody to Connective Tissue Growth Factor, in Non-Ambulatory Subjects With Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy | Drug: pamrevlumab (FG-3019) | FibroGen | NULL | Active, not recruiting | 12 Years | N/A | Male | 21 | Phase 2 | United States |
| 5 | EUCTR2020-000698-26-AT (EUCTR) | 17/08/2020 | Evaluation of Pamrevlumab for the Treatment of Male Patients Affected by Non-ambulatory Duchenne Muscular Dystrophy and just Treated with Corticosteroids | A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD) | Non-ambulatory Duchenne Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Pamrevlumab Product Code: FG-3019 INN or Proposed INN: PAMREVLUMAB | FibroGen, Inc. | NULL | NA | Female: no Male: yes | 90 | Phase 3 | United States;Slovakia;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;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 |
| 6 | EUCTR2020-000698-26-BE (EUCTR) | 21/09/2020 | Evaluation of Pamrevlumab for the Treatment of Male Patients Affected by Non-ambulatory Duchenne Muscular Dystrophy and just Treated with Corticosteroids | A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD) | Non-ambulatory Duchenne Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Pamrevlumab Product Code: FG-3019 INN or Proposed INN: PAMREVLUMAB | FibroGen, Inc. | NULL | NA | Female: no Male: yes | 90 | Phase 3 | United States;Slovakia;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Netherlands | |||
| 7 | EUCTR2020-000698-26-NL (EUCTR) | 08/09/2020 | Evaluation of Pamrevlumab for the Treatment of Male Patients Affected by Non-ambulatory Duchenne Muscular Dystrophy and just Treated with Corticosteroids | A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD) | Non-ambulatory Duchenne Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Pamrevlumab Product Code: FG-3019 INN or Proposed INN: PAMREVLUMAB | FibroGen, Inc. | NULL | NA | Female: no Male: yes | 90 | Phase 3 | United States;Slovakia;Spain;Turkey;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;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 | NCT00782561 (ClinicalTrials.gov) | April 2008 | 27/10/2008 | Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS) | A Phase I, Open-Label Study of the Safety and Pharmacokinetics of FG-3019 in Adolescent and Adult Subjects With Steroid-Resistant Focal Segmental Glomerulosclerosis | Focal Segmental Glomerulosclerosis | Drug: FG-3019 | FibroGen | NULL | Terminated | 12 Years | 64 Years | All | 2 | Phase 1 | United States |