Dornase alfa

Generic Name: Dornase alfa

Brand Names: Pulmozyme

Drug Type: Biotech

Chemical Formula: -

CAS Number: 143831-71-4

Unique Ingredient Identifier: 953A26OA1Y

Background: Dornase alfa is a biosynthetic form of human deoxyribunuclease I (DNase I) enzyme. It is produced in genetically modified Chinese hamster ovary (CHO) cells using recombinant DNA technology. The 260-amino acid sequence of dornase alfa is identical to the endogenous human enzyme. Dornase alfa cleaves extracellular DNA to 5´-phosphodinucleotide and 5´-phosphooligonucleotide end products without affecting intracellular DNA. In individuals with cystic fibrosis, extracellular DNA, which is an extremely viscous anion, is released by degenerating leukocytes that accumulate during inflammatory responses to infections. Enzymatic breakdown of this extracellular DNA appears to reduce sputum viscosity and viscoelasticity.

Indication: Used as adjunct therapy in the treatment of cystic fibrosis.

Associated Conditions: Cystic Fibrosis (CF)

Associated Therapies: -

Clinical Trials

Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit (NICU)

Phase 4

Completed

Conditions: Pulmonary Infections

Interventions: Drug: Placebo
Drug: Dornase alfa

First Posted Date: 2011-05-19

Last Posted Date: 2018-08-07

Lead Sponsor: Georgetown University

Target Recruit Count: 11

Registration Number: NCT01356147

Locations: 🇺🇸
Georgetown University Hospital, Washington, District of Columbia, United States
🇺🇸
Georgetown University Hospital NICU, Washington, District of Columbia, United States

RhDNase and Biodistribution of PMN Serine Proteases in Cystic Fibrosis Sputum

Phase 4

Completed

Conditions: Cystic Fibrosis

Interventions: Drug: Pulmozyme

First Posted Date: 2009-02-13

Last Posted Date: 2022-03-16

Lead Sponsor: University Hospital, Tours

Target Recruit Count: 15

Registration Number: NCT00843817

Locations: 🇫🇷
University Hospital - Tours, Tours, France

A Study of Pulmozyme® (Dornase Alpha) in 3- to 5-Year-Old Patients With Cystic Fibrosis

Phase 4

Terminated

Conditions: Cystic Fibrosis

Interventions: Drug: Placebo
Drug: Dornase alfa

First Posted Date: 2008-05-20

Last Posted Date: 2017-01-12

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 3

Registration Number: NCT00680316

Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis in Non-Cystic Fibrosis Patients

Not Applicable

Completed

Conditions: Atelectasis

Interventions: Drug: Hypertonic Saline
Drug: Dornase alpha

First Posted Date: 2008-05-05

Last Posted Date: 2017-07-02

Lead Sponsor: University of Oklahoma

Target Recruit Count: 33

Registration Number: NCT00671723

Locations: 🇺🇸
Presbyterian Hospital, Oklahoma City, Oklahoma, United States

Pilot Study of Pulmozyme (rhDNase) in Patients With Head and Neck Cancers Treated With Radiation Therapy + Chemotherapy

Early Phase 1

Conditions: Head and Neck Cancer

Interventions: Drug: Placebo
Drug: Pulmozyme
Radiation: Radiation Therapy

First Posted Date: 2007-09-28

Last Posted Date: 2013-06-27

Lead Sponsor: Northwestern University

Target Recruit Count: 36

Registration Number: NCT00536952

Locations: 🇺🇸
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States

A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)

Phase 4

Terminated

Conditions: Cystic Fibrosis

Interventions: Drug: placebo
Drug: Dornase alfa

First Posted Date: 2007-02-13

Last Posted Date: 2017-05-16

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 27

Registration Number: NCT00434278

Locations: 🇺🇸
Ventura County Medical Ctr, Ventura, California, United States
🇺🇸
Pulm & Critical Care Assoc, Jacksonville, Florida, United States
🇺🇸
Morristown Memorial Hospital, Morristown, New Jersey, United States

and more 37 locations

Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis

Phase 3

Completed

Conditions: Cystic Fibrosis
Chronic Rhinosinusitis

Interventions: Drug: Pulmozyme

First Posted Date: 2005-12-14

Last Posted Date: 2014-12-04

Lead Sponsor: University of Jena

Target Recruit Count: 5

Registration Number: NCT00265434

Locations: 🇩🇪
Friedrich-Schiller-Universität, Jena, Thüringen, Germany

Time of Ventilation and Lung Function of Ventilated Patients Under Therapy With Dornase Alfa

Phase 2

Conditions: Long Term Ventilation

First Posted Date: 2005-09-20

Last Posted Date: 2006-09-14

Lead Sponsor: University Hospital Tuebingen

Target Recruit Count: 540

Registration Number: NCT00204685

Locations: 🇩🇪
Charité, Universitätsmedizin Berlin, Campus Mitte, Innere Intensivstation, Berlin, Germany
🇩🇪
Universität Charité, Campus Mitte, Anästhesie, Intensivstation, Berlin, Germany
🇩🇪
Universitätsklinikum Erlangen Medizinische Klinik, Intensivstation I, Erlangen, Germany

and more 22 locations

Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis

Phase 2

Completed

Conditions: Cystic Fibrosis

Interventions: Drug: mannitol
Drug: mannitol + pulmozyme
Drug: Dornase alpha

First Posted Date: 2005-07-04

Last Posted Date: 2010-02-02

Lead Sponsor: Syntara

Target Recruit Count: 20

Registration Number: NCT00117208

Locations: 🇬🇧
Great Ormond Hospital for Children, London, United Kingdom
🇬🇧
Royal Brompton Hospital, London, United Kingdom

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy