RO7490677 ( 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25

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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-001429-30-AT
(EUCTR)
29/12/202104/01/2021A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
700Phase 3Portugal;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
2JPRN-jRCT2051210129
05/12/202105/12/2021A 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 fibrosisRO7490677 (PRM-151) is administered intravenously at 10 mg / kg every 4 weeks for 48 weeks.Makino RyokoNULLRecruiting>= 40age old<= 85age oldBoth60Phase 3Spain;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
3EUCTR2020-001429-30-NO
(EUCTR)
15/09/202107/01/2021A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;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
4EUCTR2020-000791-38-DK
(EUCTR)
06/08/202111/01/2021A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;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
5EUCTR2020-001429-30-DK
(EUCTR)
07/07/202112/01/2021A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;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
6EUCTR2020-000791-38-DE
(EUCTR)
28/05/202102/12/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;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
7EUCTR2020-001429-30-DE
(EUCTR)
26/05/202103/12/2020A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
700Phase 3Portugal;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
8EUCTR2020-000791-38-NO
(EUCTR)
25/05/202108/01/2021A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Korea, 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
9EUCTR2020-001429-30-SE
(EUCTR)
07/05/202104/12/2020A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;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
10EUCTR2020-000791-38-SE
(EUCTR)
14/04/202127/11/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;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
11EUCTR2020-001429-30-PT
(EUCTR)
09/04/202114/12/2020A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;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
12EUCTR2020-000791-38-PT
(EUCTR)
19/03/202117/12/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;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
13EUCTR2020-000791-38-FI
(EUCTR)
16/03/202109/12/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;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
14EUCTR2020-001429-30-FR
(EUCTR)
15/03/202127/11/2020A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3United 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
15EUCTR2020-000791-38-GR
(EUCTR)
18/02/202107/12/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
658Phase 3Portugal;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
16EUCTR2020-001429-30-GR
(EUCTR)
18/02/202107/12/2020A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
700Phase 3Portugal;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
17EUCTR2020-001429-30-FI
(EUCTR)
16/02/202104/01/2021A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;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
18EUCTR2020-001429-30-HU
(EUCTR)
05/02/202109/12/2020A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
700Phase 3Portugal;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
19EUCTR2020-000791-38-HU
(EUCTR)
05/02/202104/12/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLNot RecruitingFemale: yes
Male: yes
658Phase 3France;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
20EUCTR2020-001429-30-PL
(EUCTR)
28/01/202119/01/2021A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;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
21EUCTR2020-000791-38-PL
(EUCTR)
22/01/202119/01/2021A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;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
22EUCTR2020-000791-38-CZ
(EUCTR)
20/01/202130/11/2020A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3United 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
23EUCTR2020-001429-30-CZ
(EUCTR)
20/01/202102/12/2020A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3United 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
24EUCTR2020-001429-30-IT
(EUCTR)
21/12/202014/06/2021A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary FibrosisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Portugal;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
25EUCTR2020-000791-38-IT
(EUCTR)
21/12/202015/06/2021A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary FibrosisA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
658Phase 3Portugal;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