RECRUITING

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

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Conditions

Chronic Obstructive Pulmonary Diseasechronic obstructive pulmonary disease, COPD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease

Quick Facts

Study Start:2023-06-28
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05878769

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Completion of the 52-week treatment period in either parent GB43311 or GB44332
  1. * Withdrawal of consent and/or premature discontinuation from parent study
  2. * Any permanent discontinuation of study drug in parent study
  3. * Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment
  4. * Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study
  5. * 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
  6. * Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study

Contacts and Locations

Study Contact

Reference Study ID Number: GB43374 https://forpatients.roche.com/
CONTACT
888-662-6728
global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
Dothan, Alabama, 36305
United States
Jasper Summit Research LLC
Jasper, Alabama, 35501
United States
Pulmonary Associates of Mobile PC
Mobile, Alabama, 36608-3135
United States
Pulmonary Associates Deer Valley Office
Phoenix, Arizona, 85027
United States
CARE Clinical Research
Banning, California, 92220
United States
Cadena Care Institute, LLC
Poway, California, 92064-2021
United States
Allianz Research Institute Inc
Westminster, California, 92683
United States
St Francis Medical Institute ClinEdge PPDS
Clearwater, Florida, 33765
United States
Finlay Medical Research Corporation
Greenacres City, Florida, 33467-2979
United States
Flourish Research - Leesburg - PPDS
Leesburg, Florida, 34748-5077
United States
Pulmonary Specialists of the Palm Beaches
Loxahatchee Groves, Florida, 33470-9206
United States
San Marcus Research Clinic Inc.
Miami, Florida, 33014
United States
Oceane7 Medical & Research Center, Inc.
Miami, Florida, 33144-2155
United States
Research Institute of South Florida Inc
Miami, Florida, 33173-4648
United States
Central Florida Pulmonary Group, PA
Orlando, Florida, 32803
United States
Florida Institute for Clinical Research, LLC
Orlando, Florida, 32822
United States
Pivotal Research Solutions
Stonecrest, Georgia, 30038-2649
United States
Northwestern Center for Clinical Research; Clinical Research Office
Chicago, Illinois, 60611
United States
Medisphere Medical Research Center, Llc
Evansville, Indiana, 47714
United States
ASHA Clinical Research - ClinEdge - PPDS
Hammond, Indiana, 46324-2213
United States
Best Clinical Trials
New Orleans, Louisiana, 70115-3677
United States
Paul A. Shapero, MD, PA
Bangor, Maine, 04401-5691
United States
Exordia Medical Research, Inc.
Stow, Massachusetts, 01775-1205
United States
Northern Pines Health Center PC
Buckley, Michigan, 49620
United States
Pulmonary Research Institute of Southeast Michigan
Farmington Hills, Michigan, 48336-2817
United States
Flushing Road Internal Medicine and Pediatrics - F
Flint, Michigan, 48504-4730
United States
Revive Research Institute
Lathrup Village, Michigan, 48076
United States
Oakland Medical Research
Troy, Michigan, 48085
United States
Hannibal Regional Healthcare System HRMG Hannibal
Hannibal, Missouri, 63401-6890
United States
Midwest Chest Consultants
Saint Charles, Missouri, 63301
United States
Midwest Clinical Research LLC
Saint Louis, Missouri, 63141
United States
The Machuca Foundation Inc
Las Vegas, Nevada, 89104-3953
United States
Sierra Clinical Research - ClinEdge - PPDS
Las Vegas, Nevada, 89106-4159
United States
Renown Regional Medical Center Hospital
Reno, Nevada, 89502-1576
United States
American Health Research Inc.
Charlotte, North Carolina, 28277
United States
Research Carolina Elite
Denver, North Carolina, 28037-7929
United States
Clinical Research of Gastonia
Gastonia, North Carolina, 28054
United States
Carolina Research Center
Shelby, North Carolina, 28150-3803
United States
Southeastern Research Center
Winston-Salem, North Carolina, 27103-4029
United States
OK Clinical Research
Edmond, Oklahoma, 73034
United States
The Oregon Clinic.
Portland, Oregon, 97220-9442
United States
Clinical Research Associates Of Central Pa , Llc
DuBois, Pennsylvania, 15801
United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140
United States
Allergy & Clinical Immun Assoc
Pittsburgh, Pennsylvania, 15241-1041
United States
Velocity Clinical Research - Gaffney - PPDS
Gaffney, South Carolina, 29340-4737
United States
Lowcountry Lung and Critical Care
North Charleston, South Carolina, 29406
United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
United States
Velocity Clinical Research Spartanburg PPDS
Spartanburg, South Carolina, 29303-4225
United States
South Texas Medical Research Institute, Inc., dba TTS Research ? ClinEdge ? PPDS
Boerne, Texas, 78006-1993
United States
Corsicana Medical Research
Corsicana, Texas, 75110-2471
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Metroplex Pulmonary and Sleep Medicine Center
McKinney, Texas, 75069
United States
Sherman Clinical Research - ClinEdge - PPDS
Sherman, Texas, 75092
United States
University of Virginia Health System ; Division of Pulmonary and Critical Care Medicine
Charlottesville, Virginia, 22908
United States
Western Washington Medical Group
Everett, Washington, 98208
United States
Apex Clinical Research
Kennewick, Washington, 99336
United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-28
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-06-28
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • chronic obstructive pulmonary disease, COPD

Additional Relevant MeSH Terms

  • Chronic Obstructive Pulmonary Disease