299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
臨床試験数 : 1,696 / 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
| 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 | NCT04468100 (ClinicalTrials.gov) | August 30, 2017 | 8/7/2020 | Efficacy and Safety of Tigerase® vs. Pulmozyme® in Patients With Cystic Fibrosis | A 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 Fibrosis | Cystic Fibrosis;Fibrosis | Biological: Tigerase®;Biological: Pulmozyme® | AO GENERIUM | NULL | Completed | 18 Years | N/A | All | 100 | Phase 3 | Russian Federation |
| 2 | NCT02722122 (ClinicalTrials.gov) | May 2016 | 23/3/2016 | Study 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 Fibrosis | Drug: AIR DNase™ | Protalix | NULL | Recruiting | 12 Years | N/A | Both | 15 | Phase 2 | Israel |
| 3 | NCT00680316 (ClinicalTrials.gov) | June 2008 | 16/5/2008 | A Study of Pulmozyme® (Dornase Alpha) in 3- to 5-Year-Old Patients With Cystic Fibrosis | A Phase IV, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Pulmozyme® in 3- to 5-Year-Old Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Dornase alfa;Drug: Placebo | Genentech, Inc. | NULL | Terminated | 3 Years | 5 Years | All | 3 | Phase 4 | United States |
| 4 | EUCTR2015-003537-99-Outside-EU/EEA (EUCTR) | 05/07/2016 | A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis | A 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 AG | NULL | NA | Female: yes Male: yes | 80 | Phase 4 | United States |