A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Phase 3 – large-scale trial before approval
Conditions:
Chronic Obstructive Pulmonary Disease
Sponsor: Hoffmann-La Roche
trial.available_in:
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Overview
The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.
Who can participate
Inclusion Criteria:
* Completion of the 52-week treatment period in either parent GB43311 or GB44332
Exclusion Criteria:
* Withdrawal of consent and/or premature discontinuation from parent study
* Any permanent discontinuation of study drug in parent study
* Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment
* Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study
* Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study
* Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study
Locations
37
Argentina (1)
Centro Medico Capital
La Plata , Buenos Aires
Australia (1)
Flinders Medical Centre
Bedford Park , South Australia
Belgium (1)
AZ Sint-Jan Brugge-Oostende
Bruges
Brazil (1)
LMK Servicos Medicos SS
Porto Alegre , Rio Grande do Sul
Bulgaria (1)
MHAT Knyaginya Klementina Sofia EAD
Sofia , Sofia-Grad
Canada (1)
Edmonton Respiratory Consultants
Edmonton , Alberta
Chile (1)
Centro de Estudios Clinicos
Ñuñoa
China (1)
Anhui Chest Hospital
Hefei , Anhui
Czech Republic (1)
Plicní ambulance MUDr. I. Cierná Peterová s.r.o.
Brandýs nad Labem-Stará Boleslav
Denmark (1)
Aalborg Universitetshospital
Aalborg
France (1)
Clinique de l'Europe
Amiens
Greece (1)
Evangelismos General Hospital of Athens
Athens
Hong Kong (1)
Tuen Mun Hospital
Hong Kong
Hungary (1)
Obudai Egeszsegugyi Centrum Kft.-Budapest
Budapest
India (1)
Paarthiv Lung Care Center
Hyderabad , Andhra Pradesh
Israel (1)
Assuta Ashdod Medical Center
Ashdod
Italy (1)
Azienda Ospedaliera Dei Colli
Naples , Campania
Japan (1)
Japan Community Health Care Organization Hokkaido Hospital
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