The Coagulation Cascade in Idiopathic Pulmonary Fibrosis

Status Not yet recruiting

Clinical Trial Summary

The pathogenesis of idiopathic pulmonary fibrosis (IPF) is incompletely understood but recurrent epithelial injury occurs which evokes the coagulation cascade. Thrombin is produced as a result and is over expressed in IPF patients, so may be important in propagating disease activity. We aim to recruit patients with IPF and then complete FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) PET (positron emission tomography) scans pre and post manipulation of the coagulation cascade to assess the role of this biological pathway in disease activity. Previous studies from our institution have demonstrated increased FDG avidity in the lungs of patients with IPF (assessed using FDG PET scans) but to date the cells and pathways responsible for this signal have not been identified and thus need further exploration.

Clinical Trial Description

Patients with IPF who meet all the inclusion criteria (and none of the exclusion criteria) will be assessed and invite to participate.

They will undergo baseline assessment with lung function, 6 minute walk test and health quality assessments.

Blood tests will assess the pro-coagulant state of these individuals. They will undergo a baseline FDG PET scan followed by manipulation of the coagulation cascade with 24 days (+/- 3 days) dabigatran. They will then complete a second FDG PET, health quality assessments and blood tests to demonstrate target engagement. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02885961
Study type	Interventional
Source	University College, London
Contact	Joanna C Porter, PhD FRCP
Phone	02076796972
Email	joanna.porter@ucl.ac.uk
Status	Not yet recruiting
Phase	N/A
Start date	August 2016

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05984992` - The First-in-human Study of SRN-001 in Healthy Participants	Phase 1
Active, not recruiting	`NCT04312594` - Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis	Phase 2
Recruiting	`NCT03865927` - GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis	Phase 2
Completed	`NCT03979430` - Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study	N/A
Enrolling by invitation	`NCT04905693` - Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis	Phase 3
Not yet recruiting	`NCT06241560` - A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood	Phase 2
Terminated	`NCT04419558` - Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)	Phase 3
Completed	`NCT03725852` - A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF)	Phase 2
Terminated	`NCT03573505` - An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis	Phase 2
Recruiting	`NCT04148157` - Quality of Life in IPF - Patient and Physician Perceptions
Completed	`NCT03222648` - Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis	N/A
Not yet recruiting	`NCT06422884` - A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)	Phase 2
Completed	`NCT02268981` - Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)	N/A
Completed	`NCT02257177` - RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients	Phase 1/Phase 2
Withdrawn	`NCT01524068` - A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations	Phase 2
Enrolling by invitation	`NCT01382368` - Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients	Phase 4
Completed	`NCT01199887` - Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis	Phase 1
Completed	`NCT01110694` - Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study
Active, not recruiting	`NCT02951416` - Clinical Course of Interstitial Lung Diseases: European IPF Registry and Biobank
Terminated	`NCT00981747` - Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis	Phase 2/Phase 3