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NCT05130970CompletedPhase 2

Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis

A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Garadacimab in Subjects With Idiopathic Pulmonary Fibrosis

Source: ClinicalTrials.gov · Last updated 13 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This is a prospective, phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of garadacimab in subjects with idiopathic pulmonary fibrosis (IPF).

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
81 (actual)
First submitted
12 Nov 2021
Start date
3 Feb 2022
Primary completion date
2 Jan 2024
Lead sponsor
CSL Behring
NCT number
NCT05130970

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 81
  • From 3 Feb 2022 to the primary completion date, 2 Jan 2024
  • 47 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of clinically significant cardiovascular disease, including myocardial infarction, unstable ischemic heart disease, congestive heart failure, or angina during the 6 months before screening

Other illness

  • Sinoatrial or atrioventricular block, uncontrolled hypertension
  • Active bleeding or current clinically significant coagulopathy

Who the study is looking for

  • Male or female patients ≥ 40 years of age
  • Documented diagnosis of IPF

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (47)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medizinische Univerität Graz
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GrazAustriaUnknown status
Kepler Universitätsklinikum
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LinzAustriaUnknown status
Royal Adelaide Hospital
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AdelaideAustraliaUnknown status
Universitair Ziekenhuis (Uz) Leuven
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LeuvenBelgiumUnknown status
Centre Hospitalier Universitaire Sart Tilman
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LiègeBelgiumUnknown status
St. Joseph's Healthcare Hamilton
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HamiltonCanadaUnknown status
Dr. Syed Anees Medicine Professional Corporation
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WindsorCanadaUnknown status
Fachkrankenhaus Coswig GmbH
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CoswigGermanyUnknown status
Universitaetsklinikum Essen - Ruhrlandklinik (Westdeutsches Lungenzentrum)
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EssenGermanyUnknown status
Medizinische Hochschule Hannover - Klinik für Pneumologie
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HanoverGermanyUnknown status
Petrus-Krankenhaus Wuppertal
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WuppertalGermanyUnknown status
Odense Universitetshospital - Lungemedicinsk Forskningsenhed
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OdenseDenmarkUnknown status
Giromed Institute, SLP
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BarcelonaSpainUnknown status
Hospital Universitario Puerta del Mar (HUPM)
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CadizSpainUnknown status
Queen Elizabeth Hospital
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BirminghamUnited KingdomUnknown status
Altnagelvin Area Hospital
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LondonderryUnited KingdomUnknown status
Manchester Univ NHS - Wythenshawe Hospital
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ManchesterUnited KingdomUnknown status
The Churchill Hospital - Oxford University Hospitals NHS Trust
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OxfordUnited KingdomUnknown status
Azienda Ospedaliera Universitaria Ospedali Riuniti - Foggia
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FoggiaItalyUnknown status
Centrum Medycyny Oddechowej Bialymstoku
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BialystokPolandUnknown status
Twoja Przychodnia Centrum Medyczne Nowa Sól
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Nowa SólPolandUnknown status
Centrum Badań Klinicznych NZOZ
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WroclawPolandUnknown status
The University of Alabama at Birmingham
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BirminghamUnited StatesUnknown status
Meris Clinical Research
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BrandonUnited StatesUnknown status
University of Cincinnati
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CincinnatiUnited StatesUnknown status
Southwest Family Medicine Associates
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DallasUnited StatesUnknown status
Elite Medical Research
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DallasUnited StatesUnknown status
Baylor Scott and White Health - Advanced Lung Disease Specialists
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DallasUnited StatesUnknown status
Clinical Trial Center of Middle Tennesse
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FranklinUnited StatesUnknown status
Hannibal Clinic
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HannibalUnited StatesUnknown status
Baylor College of Medicine
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HoustonUnited StatesUnknown status
National Institute of Clinical Research
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Huntington BeachUnited StatesUnknown status
University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
University of Southern California - Center for Advanced Lung Disease
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Los AngelesUnited StatesUnknown status
US Associates in Research, LLC
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MiamiUnited StatesUnknown status
Reliant Medical Research
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MiamiUnited StatesUnknown status
Lakes Research
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Miami LakesUnited StatesUnknown status
Weill Cornell Medical Center
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New YorkUnited StatesUnknown status
Renstar Medical Research
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OcalaUnited StatesUnknown status
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesUnknown status
University of California Irvine
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OrangeUnited StatesUnknown status
Central Florida Pulmonary Group, PA
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OrlandoUnited StatesUnknown status
Temple University TMS
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PhiladelphiaUnited StatesUnknown status
Pulmonary Associates Clinical Trials AZ
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PhoenixUnited StatesUnknown status
Jadestone Clinical Research
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Silver SpringUnited StatesUnknown status
Superior Clinical Research
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SmithfieldUnited StatesUnknown status
Southeastern Research Center
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Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.