Pulmozyme® ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
299嚢胞性線維症5

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT04468100
(ClinicalTrials.gov)
August 30, 20178/7/2020Efficacy and Safety of Tigerase® vs. Pulmozyme® in Patients With Cystic FibrosisA Multicenter Prospective Randomized Comparative Study of Pharmacokinetics, Clinical Efficacy and Safety of Tigerase® (JSC GENERIUM, Russia) vs. Pulmozyme® (Hoffmann-La Roche, Switzerland) as Part of Complex Therapy in Patients With Cystic FibrosisCystic Fibrosis;FibrosisBiological: Tigerase®;Biological: Pulmozyme®AO GENERIUMNULLCompleted18 YearsN/AAll100Phase 3Russian Federation
2NCT02722122
(ClinicalTrials.gov)
May 201623/3/2016Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme®A Proof-of-Concept, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme®Cystic FibrosisDrug: AIR DNase™ProtalixNULLRecruiting12 YearsN/ABoth15Phase 2Israel
3NCT01712334
(ClinicalTrials.gov)
December 201219/10/2012A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic FibrosisA Phase IV Multicenter, Randomized, Open Label, Two-Period, Crossover Study in Patients With Cystic Fibrosis to Evaluate the Comparable Efficacy and Safety of Pulmozyme Delivered by the eRapid Nebulizer SystemCystic FibrosisDrug: dornase alfa [Pulmozyme®]Genentech, Inc.NULLCompleted6 YearsN/AAll99Phase 4United States
4NCT00680316
(ClinicalTrials.gov)
June 200816/5/2008A Study of Pulmozyme® (Dornase Alpha) in 3- to 5-Year-Old Patients With Cystic FibrosisA Phase IV, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Pulmozyme® in 3- to 5-Year-Old Patients With Cystic FibrosisCystic FibrosisDrug: Dornase alfa;Drug: PlaceboGenentech, Inc.NULLTerminated3 Years5 YearsAll3Phase 4United States
5EUCTR2015-003537-99-Outside-EU/EEA
(EUCTR)
05/07/2016A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic FibrosisA PHASE IV MULTICENTER, RANDOMIZED, OPEN LABEL, TWO-PERIOD CROSSOVER STUDY IN PATIENTS WITH CYSTIC FIBROSIS TO EVALUATE THE COMPARABLE EFFICACY AND SAFETY OF PULMOZYME® DELIVERED BY THE ERAPID™ NEBULIZER SYSTEM Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Pulmozyme
Product Name: Pulmozyme
INN or Proposed INN: DORNASE ALFA
F. Hoffmann-La Roche AGNULLNAFemale: yes
Male: yes
80Phase 4United States