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
- Diseases
- Idiopathic pulmonary fibrosis
- 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
Sites (47)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Univerität Graz Coordinator of this site? Confirm its status | Graz | Austria | Unknown status |
| Kepler Universitätsklinikum Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Universitair Ziekenhuis (Uz) Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Centre Hospitalier Universitaire Sart Tilman Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| St. Joseph's Healthcare Hamilton Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Dr. Syed Anees Medicine Professional Corporation Coordinator of this site? Confirm its status | Windsor | Canada | Unknown status |
| Fachkrankenhaus Coswig GmbH Coordinator of this site? Confirm its status | Coswig | Germany | Unknown status |
| Universitaetsklinikum Essen - Ruhrlandklinik (Westdeutsches Lungenzentrum) Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Medizinische Hochschule Hannover - Klinik für Pneumologie Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Petrus-Krankenhaus Wuppertal Coordinator of this site? Confirm its status | Wuppertal | Germany | Unknown status |
| Odense Universitetshospital - Lungemedicinsk Forskningsenhed Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
| Giromed Institute, SLP Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Puerta del Mar (HUPM) Coordinator of this site? Confirm its status | Cadiz | Spain | Unknown status |
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Altnagelvin Area Hospital Coordinator of this site? Confirm its status | Londonderry | United Kingdom | Unknown status |
| Manchester Univ NHS - Wythenshawe Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| The Churchill Hospital - Oxford University Hospitals NHS Trust Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Azienda Ospedaliera Universitaria Ospedali Riuniti - Foggia Coordinator of this site? Confirm its status | Foggia | Italy | Unknown status |
| Centrum Medycyny Oddechowej Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| Twoja Przychodnia Centrum Medyczne Nowa Sól Coordinator of this site? Confirm its status | Nowa Sól | Poland | Unknown status |
| Centrum Badań Klinicznych NZOZ Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| The University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Meris Clinical Research Coordinator of this site? Confirm its status | Brandon | United States | Unknown status |
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Southwest Family Medicine Associates Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Elite Medical Research Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Baylor Scott and White Health - Advanced Lung Disease Specialists Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Clinical Trial Center of Middle Tennesse Coordinator of this site? Confirm its status | Franklin | United States | Unknown status |
| Hannibal Clinic Coordinator of this site? Confirm its status | Hannibal | United States | Unknown status |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| National Institute of Clinical Research Coordinator of this site? Confirm its status | Huntington Beach | United States | Unknown status |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University of Southern California - Center for Advanced Lung Disease Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| US Associates in Research, LLC Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Reliant Medical Research Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Lakes Research Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Weill Cornell Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Renstar Medical Research Coordinator of this site? Confirm its status | Ocala | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| University of California Irvine Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Central Florida Pulmonary Group, PA Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Temple University TMS Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Pulmonary Associates Clinical Trials AZ Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Jadestone Clinical Research Coordinator of this site? Confirm its status | Silver Spring | United States | Unknown status |
| Superior Clinical Research Coordinator of this site? Confirm its status | Smithfield | United States | Unknown status |
| Southeastern Research Center Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.