85. 特発性間質性肺炎 Idiopathic interstitial pneumonia Clinical trials / Disease details
臨床試験数 : 598 / 薬物数 : 435 - (DrugBank : 116) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 210
| 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 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 | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;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;Norway;Germany;New Zealand;Sweden | ||
| 2 | EUCTR2020-001429-30-NO (EUCTR) | 15/09/2021 | 07/01/2021 | 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 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 | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;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;Norway;Germany;New Zealand;Sweden | ||
| 3 | NCT04594707 (ClinicalTrials.gov) | August 30, 2021 | 15/10/2020 | A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants 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 | Drug: PRM-151 | Hoffmann-La Roche | NULL | Recruiting | N/A | N/A | All | 700 | Phase 3 | United States;Argentina;Australia;Belgium;China;Czechia;France;Israel;Italy;Mexico;Netherlands;New Zealand;Peru;Poland;Spain;Austria;Brazil;Canada;Denmark;Germany;Greece;Hong Kong;Hungary;Puerto Rico;South Africa;Sweden;Switzerland;Ukraine |
| 4 | 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 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 | Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden;United Kingdom;Austria;Turkey;Finland;Czechia;Korea, Republic of;China;Netherlands;South Africa;Denmark;Australia;Peru;France;Italy;Switzerland;Israel;Russian Federation;Ukraine;Spain;Greece;Taiwan;Hong Kong;United States;Portugal | ||
| 5 | EUCTR2020-001429-30-DK (EUCTR) | 07/07/2021 | 12/01/2021 | 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 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 | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;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;Norway;Germany;New Zealand;Sweden | ||
| 6 | 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 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;Switzerland;Italy;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;Norway;Germany;New Zealand;Sweden | ||
| 7 | 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/F01-01 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677/F01-02 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677/F01-03 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 | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;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;Norway;Germany;New Zealand;Sweden | ||
| 8 | EUCTR2020-000791-38-NO (EUCTR) | 25/05/2021 | 08/01/2021 | 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 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 | Korea, Republic of;Czechia;Finland;Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 9 | EUCTR2020-001429-30-NL (EUCTR) | 07/05/2021 | 01/02/2021 | 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 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;Switzerland;Italy;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;Norway;Germany;New Zealand;Sweden | ||
| 10 | EUCTR2020-001429-30-SE (EUCTR) | 07/05/2021 | 04/12/2020 | 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/F01-01 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677/F01-02 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677/F01-03 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 | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;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;Norway;Germany;New Zealand;Sweden | ||
| 11 | EUCTR2020-000791-38-NL (EUCTR) | 29/04/2021 | 21/01/2021 | 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 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;Switzerland;Italy;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;Norway;Germany;New Zealand;Sweden | ||
| 12 | 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 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;Switzerland;Italy;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;Norway;Germany;New Zealand;Sweden | ||
| 13 | EUCTR2020-001429-30-PT (EUCTR) | 09/04/2021 | 14/12/2020 | 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 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 | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;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;Norway;Germany;New Zealand;Sweden | ||
| 14 | NCT04552899 (ClinicalTrials.gov) | March 19, 2021 | 14/9/2020 | A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants 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 | Drug: PRM-151;Drug: Placebo | Hoffmann-La Roche | NULL | Recruiting | 40 Years | 85 Years | All | 658 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;China;Czechia;Denmark;France;Germany;Greece;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Norway;Peru;Poland;Portugal;Spain;Taiwan;Turkey;Ukraine;Brazil;Finland;Puerto Rico;Russian Federation;Singapore;South Africa;Sweden;Switzerland;United Kingdom |
| 15 | EUCTR2020-000791-38-PT (EUCTR) | 19/03/2021 | 17/12/2020 | 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 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;Switzerland;Italy;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;Norway;Germany;New Zealand;Sweden | ||
| 16 | EUCTR2020-000791-38-FI (EUCTR) | 16/03/2021 | 09/12/2020 | 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 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;Switzerland;Italy;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;Norway;Germany;New Zealand;Sweden | ||
| 17 | EUCTR2020-001429-30-FR (EUCTR) | 15/03/2021 | 27/11/2020 | 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 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 | 700 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Norway;New Zealand;Sweden | ||
| 18 | EUCTR2020-001429-30-GR (EUCTR) | 18/02/2021 | 07/12/2020 | 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 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 | 700 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Norway;New Zealand;Sweden | ||
| 19 | 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 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 | United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Norway;New Zealand;Sweden | ||
| 20 | EUCTR2020-001429-30-FI (EUCTR) | 16/02/2021 | 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 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 | 700 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Norway;New Zealand;Sweden | ||
| 21 | EUCTR2020-001429-30-HU (EUCTR) | 05/02/2021 | 09/12/2020 | 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 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 | 700 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Norway;New Zealand;Sweden | ||
| 22 | EUCTR2020-000791-38-HU (EUCTR) | 05/02/2021 | 04/12/2020 | 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 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 | United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;New Zealand;Sweden;Norway;Germany;Singapore;Poland;Belgium;Brazil;Argentina;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Austria;Turkey;Finland;Czechia;Korea, Republic of;China;Netherlands;South Africa;Peru;Australia;Denmark;France | ||
| 23 | EUCTR2020-001429-30-PL (EUCTR) | 28/01/2021 | 19/01/2021 | 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 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677/ F01-02 INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677/F01-03 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 | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 24 | EUCTR2020-000791-38-PL (EUCTR) | 22/01/2021 | 19/01/2021 | 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 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;Switzerland;Italy;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Norway;Germany;New Zealand;Sweden | ||
| 25 | EUCTR2020-000791-38-CZ (EUCTR) | 20/01/2021 | 30/11/2020 | 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 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 | United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Norway;New Zealand;Sweden | ||
| 26 | EUCTR2020-001429-30-CZ (EUCTR) | 20/01/2021 | 02/12/2020 | 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 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 | 700 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Denmark;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Norway;New Zealand;Sweden | ||
| 27 | EUCTR2020-001429-30-IT (EUCTR) | 21/12/2020 | 14/06/2021 | 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] 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 | 700 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;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;Norway;Germany;New Zealand;Sweden | ||
| 28 | EUCTR2020-000791-38-IT (EUCTR) | 21/12/2020 | 15/06/2021 | 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] 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;Switzerland;Italy;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;Norway;Germany;New Zealand;Sweden |