299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
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. | 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 | NCT01155752 (ClinicalTrials.gov) | July 2013 | 25/6/2010 | Pulmozyme in Cystic Fibrosis With Sinusitis | Z4770s, Use of Recombinant Human DNASE in Cystic Fibrosis Patients With Chronic Sinusitis to Prevent Acute Sinusitis Exacerbations and Improve Symptoms and Outcomes - A Pilot Study | Sinusitis;Cystic Fibrosis | Drug: Pulmozyme single use ampule;Drug: placebo | Milton S. Hershey Medical Center | Genentech, Inc. | Withdrawn | 12 Years | 65 Years | All | 0 | Phase 3 | United States |
| 4 | NCT01712334 (ClinicalTrials.gov) | December 2012 | 19/10/2012 | 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 | Drug: dornase alfa [Pulmozyme®] | Genentech, Inc. | NULL | Completed | 6 Years | N/A | All | 99 | Phase 4 | United States |
| 5 | NCT00843817 (ClinicalTrials.gov) | April 2009 | 12/2/2009 | RhDNase and Biodistribution of PMN Serine Proteases in Cystic Fibrosis Sputum | RhDNase Effect on Biodistribution of PMN Serine Proteases in Cystic Fibrosis Sputum | Cystic Fibrosis | Drug: Pulmozyme | University Hospital, Tours | NULL | Completed | 18 Years | N/A | All | 15 | Phase 4 | France |
| 6 | 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 |
| 7 | NCT00534079 (ClinicalTrials.gov) | September 2007 | 21/9/2007 | Nasal Inhalation of Pulmozyme in Patients With Cystic Fibrosis and Chronic Rhinosinusitis | Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis - a Double Blind Placebo-controlled Cross-over, Bicenter, Prospective Clinical Study | Cystic Fibrosis;Rhinosinusitis | Drug: Dornase alfa (Pulmozyme);Drug: isotonic saline | University of Jena | NULL | Completed | 5 Years | N/A | Both | 23 | Phase 3 | Germany |
| 8 | NCT00434278 (ClinicalTrials.gov) | March 2007 | 11/2/2007 | A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease | Cystic Fibrosis | Drug: Dornase alfa;Drug: placebo | Genentech, Inc. | NULL | Terminated | 14 Years | N/A | All | 27 | Phase 4 | United States |
| 9 | NCT00416182 (ClinicalTrials.gov) | December 2006 | 26/12/2006 | Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis | The Use of Nasally Delivered Pulmozyme in the Treatment of Sinusitis in Cystic Fibrosis Patients: A Pilot Study | Sinusitis;Cystic Fibrosis | Drug: Pulmozyme (dornase alfa);Drug: Placebo | University of Vermont | Genentech, Inc. | Completed | 5 Years | N/A | All | 16 | Phase 2 | United States |
| 10 | NCT00265434 (ClinicalTrials.gov) | December 2005 | 13/12/2005 | Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis | Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis | Cystic Fibrosis;Chronic Rhinosinusitis | Drug: Pulmozyme | University of Jena | PD Dr. Joachim Riethmöller, Tübingen;PD Dr. Assen Koitschev, Tübingen;Dr. Gerlind Schneider | Completed | 5 Years | N/A | Both | 5 | Phase 3 | Germany |
| 11 | NCT00117208 (ClinicalTrials.gov) | November 2005 | 30/6/2005 | Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis | A Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic Fibrosis | Cystic Fibrosis | Drug: mannitol;Drug: mannitol + pulmozyme;Drug: Dornase alpha | Pharmaxis | NULL | Completed | 8 Years | 18 Years | Both | 20 | Phase 2 | United Kingdom |
| 12 | NCT00179998 (ClinicalTrials.gov) | January 2005 | 10/9/2005 | Effectiveness of Pulmozyme in Infants With Cystic Fibrosis | Efficacy of Pulmozyme in Infants and Young Children With Cystic Fibrosis | Cystic Fibrosis | Drug: Recombinant Human DNase (Pulmozyme);Drug: Placebos | Nationwide Children's Hospital | Genentech, Inc. | Completed | 1 Month | 30 Months | All | 24 | Phase 2 | United States |
| 13 | EUCTR2004-001888-21-GB (EUCTR) | 03/12/2004 | 22/02/2005 | A cross-over comparative study of inhaled mannitol, alone and in combination with daily rhDNase, in children with cystic fibrosis - Inhaled Mannitol in Cystic Fibrosis | A cross-over comparative study of inhaled mannitol, alone and in combination with daily rhDNase, in children with cystic fibrosis - Inhaled Mannitol in Cystic Fibrosis | Cystic fibrosis (CF) | Product Name: DP Mannitol INN or Proposed INN: Mannitol Trade Name: Pulmozyme (dornase alfa) Product Name: Pulmozyme (dornase alfa) INN or Proposed INN: Dornase alfa Other descriptive name: rhDNAse | Pharmaxis Ltd | NULL | Not Recruiting | Female: yes Male: yes | 42 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 14 | EUCTR2007-001548-36-DE (EUCTR) | 27/07/2009 | Nasale Inhalation von Pulmozyme bei Patienten mit Mukoviszidose und chronischer Rhinosinusitis mit dem Pari Sinus-Vernebler.- bizentrische, randomisierte, doppel-blinde, placebo-kontrollierte, prospektive klinische Studie -Nasal Inhalation of Dornase alfa (Pulmozyme) in Patients with Cystic Fibrosis and Chronic Rhinosinusitis - pulmozyme-nasal-cf | Nasale Inhalation von Pulmozyme bei Patienten mit Mukoviszidose und chronischer Rhinosinusitis mit dem Pari Sinus-Vernebler.- bizentrische, randomisierte, doppel-blinde, placebo-kontrollierte, prospektive klinische Studie -Nasal Inhalation of Dornase alfa (Pulmozyme) in Patients with Cystic Fibrosis and Chronic Rhinosinusitis - pulmozyme-nasal-cf | Cystic Fibrosis with chronic rhinosinusitis | Trade Name: Pulmozyme Product Name: Pulmozyme INN or Proposed INN: Dornase alfa Other descriptive name: recombiant human Desoxyribonuclease ( rhDNase) | University of Jena | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 3 | Germany | |||
| 15 | 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 | |||
| 16 | EUCTR2007-000935-25-NL (EUCTR) | 02/04/2007 | ‘Peripheral targeting of inhaled rhDNase in stable CF patients.’ | ‘Peripheral targeting of inhaled rhDNase in stable CF patients.’ | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Pulmozyme (Dornase alpha) Product Name: Pulmozyme | ErasmusMC - Sophia Children's Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Netherlands |