Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis
NCT ID: NCT05130970
Last Updated: 2024-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
81 participants
INTERVENTIONAL
2022-02-03
2024-01-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Garadacimab
Administered IV and SC
Garadacimab
Participants received garadacimab intravenous (IV) loading dose followed by 3 subcutaneous (SC) doses.
Placebo
Administered IV and SC
Placebo
Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Interventions
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Garadacimab
Participants received garadacimab intravenous (IV) loading dose followed by 3 subcutaneous (SC) doses.
Placebo
Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented diagnosis of IPF
Exclusion Criteria
* Sinoatrial or atrioventricular block, uncontrolled hypertension
* Active bleeding or current clinically significant coagulopathy
40 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
CSL Behring
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Pulmonary Associates Clinical Trials AZ
Phoenix, Arizona, United States
National Institute of Clinical Research
Huntington Beach, California, United States
University of Southern California - Center for Advanced Lung Disease
Los Angeles, California, United States
University of California Irvine
Orange, California, United States
Meris Clinical Research
Brandon, Florida, United States
Reliant Medical Research
Miami, Florida, United States
US Associates in Research LLC
Miami, Florida, United States
Lakes Research
Miami Lakes, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Central Florida Pulmonary Group, PA
Orlando, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Jadestone Clinical Research
Silver Spring, Maryland, United States
Hannibal Clinic
Hannibal, Missouri, United States
Weill Cornell Medical Center
New York, New York, United States
Superior Clinical Research
Smithfield, North Carolina, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Temple University TMS
Philadelphia, Pennsylvania, United States
Clinical Trial Center of Middle Tennesse
Franklin, Tennessee, United States
Elite Medical Research
Dallas, Texas, United States
Southwest Family Medicine Associates
Dallas, Texas, United States
Baylor Scott and White Health - Advanced Lung Disease Specialists
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Royal Adelaide Hospital
Adelaide, , Australia
Medizinische Univerität Graz
Graz, , Austria
Kepler Universitätsklinikum
Linz, , Austria
Universitair Ziekenhuis (UZ) Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire Sart Tilman
Liège, , Belgium
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Dr. Syed Anees Medicine Professional Corporation
Windsor, Ontario, Canada
Odense Universitetshospital - Lungemedicinsk Forskningsenhed
Odense, , Denmark
Fachkrankenhaus Coswig GmbH
Coswig, , Germany
Universitaetsklinikum Essen - Ruhrlandklinik (Westdeutsches Lungenzentrum)
Essen, , Germany
Medizinische Hochschule Hannover - Klinik für Pneumologie
Hanover, , Germany
Petrus Krankenhaus Wuppertal
Wuppertal, , Germany
Azienda Ospedaliera Universitaria Ospedali Riuniti Foggia
Foggia, , Italy
Centrum Medycyny Oddechowej Bialymstoku
Bialystok, , Poland
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sól, , Poland
Centrum Badań Klinicznych NZOZ
Wroclaw, , Poland
Giromed Institute, SLP
Barcelona, , Spain
Hospital Universitario Puerta del Mar (HUPM)
Cadiz, , Spain
The Churchill Hospital - Oxford University Hospitals NHS Trust
Oxford, MD, United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Altnagelvin Area Hospital
Londonderry, , United Kingdom
Manchester Univ NHS - Wythenshawe Hospital
Manchester, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021 003162 12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSL312_2002
Identifier Type: -
Identifier Source: org_study_id