85. 特発性間質性肺炎 Idiopathic interstitial pneumonia Clinical trials / Disease details
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 | JPRN-jRCT2001210001 | 06/01/2022 | 26/12/2021 | A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151(rhPTX-2) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) | A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151(rhPTX-2) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) - WA42294 | Idiopathic pulmonary fibrosis | Patients will receive IV infusions of 10 mg/kg PRM-151 over 50-70 minutes, with dose based on the patients weight recorded at each visit | Shimoda Yukiko | NULL | Pending | >= 40age old | Not applicable | Both | 60 | Phase 3 | Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czech Republic;Denmark;Finland;France;Germany;Greece;Hong Kong;Hungary;Israel;Italy;South Korea;Mexico;Netherlands;New Zealand;Norway;Peru;Poland;Portugal;Russian Federation;Singapore;South Africa;Spain;Sweden;Japan |
| 2 | 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 | ||
| 3 | JPRN-jRCT2051210129 | 05/12/2021 | 05/12/2021 | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151(rhPTX-2) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (STARSCAPE) | A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PRM-151(rhPTX-2) IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (STARSCAPE) - WA42293 | Idiopathic pulmonary fibrosis | RO7490677 (PRM-151) is administered intravenously at 10 mg / kg every 4 weeks for 48 weeks. | Makino Ryoko | NULL | Recruiting | >= 40age old | <= 85age old | Both | 60 | Phase 3 | Spain;Sweden;Japan;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czech Republic;Denmark;Finland;France;Germany;Greece;Hong Kong;Hungary;Israel;Italy;South Korea;Mexico;Netherlands;New Zealand;Norway;Peru;Poland;Portugal;Russian Federation;Singapore;South Africa |
| 4 | 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/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 | 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;Germany;Norway;New Zealand;Sweden | ||
| 5 | 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 (Zinpentraxin Alfa) | Hoffmann-La Roche | NULL | Terminated | N/A | N/A | All | 117 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;China;Czechia;Denmark;France;Germany;Greece;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Singapore;South Africa;Spain;Taiwan;Turkey;Austria;Brazil;Peru;Puerto Rico;Russian Federation;Sweden;Switzerland;Ukraine |
| 6 | 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 | ||
| 7 | 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/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 | 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-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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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: Zinpetraxin Alfa 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 | ||
| 12 | 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 | ||
| 13 | 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: Zinpetraxin Alfa 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 (Zinpentraxin Alfa);Drug: Placebo | Hoffmann-La Roche | NULL | Completed | 40 Years | 85 Years | All | 665 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czechia;Denmark;Finland;France;Germany;Greece;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Singapore;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Peru;Puerto Rico;Russian Federation |
| 18 | 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 160 mg/8 ml INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 320 mg/16 ml (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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | 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/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 | 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 | ||
| 22 | 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 160 mg/8 ml INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-151 Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 320 mg/16 ml (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 | 700 | 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 | ||
| 23 | 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 | Not Recruiting | Female: yes Male: yes | 658 | Phase 3 | 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;Switzerland;Italy;Portugal;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Israel | ||
| 24 | 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 | Not Recruiting | 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 | ||
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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 | ||
| 30 | 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 | ||
| 31 | EUCTR2014-004782-24-HU (EUCTR) | 09/08/2016 | 14/04/2016 | A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Code: PRM-151 INN or Proposed INN: PRM-151 | Promedior, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 117 | Phase 2 | United States;Czech Republic;Hungary;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 32 | EUCTR2014-004782-24-CZ (EUCTR) | 25/04/2016 | 11/08/2015 | A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe. | A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects 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: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Code: PRM-151 INN or Proposed INN: PRM-151 | Promedior, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 117 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Hungary;Czech Republic;Spain;Belgium;Netherlands;Germany;United Kingdom | ||
| 33 | EUCTR2014-004782-24-ES (EUCTR) | 31/03/2016 | 15/12/2015 | A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe. | A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Code: PRM-151 INN or Proposed INN: PRM-151 | Promedior, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 117 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Czech Republic;Belgium;Spain;Netherlands;Germany;United Kingdom | ||
| 34 | EUCTR2014-004782-24-DE (EUCTR) | 01/03/2016 | 19/05/2015 | A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe. | A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Code: PRM-151 INN or Proposed INN: PRM-151 | Promedior, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 117 | Phase 2 | United States;Hungary;Czech Republic;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 35 | EUCTR2014-004782-24-IT (EUCTR) | 22/12/2015 | 06/09/2021 | A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe. | A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - PRM-151-202 | 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: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Code: PRM-151 | PROMEDIOR, INC. | NULL | Not Recruiting | Female: yes Male: yes | 117 | Phase 2 | France;United States;Czechia;Hungary;Czech Republic;Spain;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 36 | EUCTR2014-004782-24-BE (EUCTR) | 06/11/2015 | 27/05/2015 | A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe. | A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Code: PRM-151 INN or Proposed INN: PRM-151 | Promedior, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 117 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Czech Republic;Spain;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 37 | NCT02550873 (ClinicalTrials.gov) | September 7, 2015 | 27/8/2015 | A Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Biological: PRM-151;Other: placebo | Hoffmann-La Roche | NULL | Completed | 40 Years | 80 Years | All | 117 | Phase 2 | United States;Czechia;Germany;Italy;Netherlands;Spain;Switzerland;Belgium;Czech Republic;Israel;United Kingdom |
| 38 | EUCTR2014-004782-24-NL (EUCTR) | 06/05/2015 | 08/12/2014 | A study to test intravenous PRM-151 for safety and to see how PRM-151 acts in the body and blood of people with idiopathic pulmonary fibrosis (IPF) - a disorder where lung tissue becomes damaged and scarred making it difficult to breathe. | A Pilot Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF). | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 17.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Code: PRM-151 | Promedior inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Netherlands | |||
| 39 | NCT01254409 (ClinicalTrials.gov) | January 2011 | 3/12/2010 | A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | A Randomized, Double-Masked, Sponsor-Unmasked, Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRM-151 Administered Intravenously to Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Biological: PRM-151;Other: Placebo | Hoffmann-La Roche | NULL | Completed | 40 Years | 80 Years | All | 21 | Phase 1 | United States;Netherlands |