RO7490677 160 mg/8 ml ( 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2

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
1EUCTR2020-000791-38-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
2EUCTR2020-001429-30-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