RO7490677 320mg/16mL (2nd generation) ( DrugBank: - )
1 disease
| 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 | 6 |
85. 特発性間質性肺炎
臨床試験数 : 627 / 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
| 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 | EUCTR2020-001429-30-AT (EUCTR) | 29/12/2021 | 04/01/2021 | A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) | Idiopathic pulmonary fibrosis (IPF) 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: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 160mg/8mL INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 320mg/16mL (2nd generation) INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 2 | EUCTR2020-000791-38-DK (EUCTR) | 06/08/2021 | 11/01/2021 | A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic pulmonary fibrosis (IPF) 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: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 160mg/8mL INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 320mg/16mL (2nd generation) INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 658 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 3 | EUCTR2020-000791-38-DE (EUCTR) | 28/05/2021 | 02/12/2020 | A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic pulmonary fibrosis (IPF) 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: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 160 mg/8mL INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 320mg/16mL (2nd generation) INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 658 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 4 | EUCTR2020-001429-30-DE (EUCTR) | 26/05/2021 | 03/12/2020 | A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) | Idiopathic pulmonary fibrosis (IPF) 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: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 160mg/8mL INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 320mg/16mL (1st generation) INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 320mg/16mL (2nd generation) INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 5 | EUCTR2020-000791-38-SE (EUCTR) | 14/04/2021 | 27/11/2020 | A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic pulmonary fibrosis (IPF) 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: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 160mg/8mL INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 320mg/16mL (2nd generation) INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 658 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Germany;Norway;New Zealand;Sweden | ||
| 6 | EUCTR2020-000791-38-GR (EUCTR) | 18/02/2021 | 07/12/2020 | A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS | Idiopathic pulmonary fibrosis (IPF) 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: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 160mg/8mL INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 320mg/16mL (2nd generation) INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 658 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Norway;Germany;New Zealand;Sweden |