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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 September 2016 |
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Main ID: |
NCT02885961 |
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Date of registration:
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15/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Coagulation Cascade in Idiopathic Pulmonary Fibrosis
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Scientific title:
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Investigating the Role of the Coagulation Cascade in Idiopathic Pulmonary Fibrosis |
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Date of first enrolment:
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August 2016 |
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Target sample size:
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12 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02885961 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Phase:
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N/A
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Contacts
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Name:
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Joanna C Porter, PhD FRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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University College, London |
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Name:
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Joanna C Porter, PhD FRCP |
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Address:
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Telephone:
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02076796972 |
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Email:
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joanna.porter@ucl.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- A diagnosis of IPF based on multi disciplinary meeting discussion following review of
the clinical history, characteristic features on HRCT (high resolution CT scan)
and/or usual interstitial pneumonia (UIP) histology.
- Written informed consent obtained from subject.
Exclusion Criteria:
- Age <40 or >80 years
- Renal impairment as defined by a creatinine clearance of <30 millilitres/min
- Significant liver impairment with evidence of synthetic dysfunction
- Any contraindication to anti-coagulation including previous life threatening or
serious bleed or bleeding tendency.
- Co-administration of any concomitant medications prohibited in full protocol.
N-acetyl cysteine, prednisolone up to 10mg daily and pirfenidone are permitted.
- Pregnant, breast feeding or unwilling to practice birth control during participation
in the study (females of child bearing age).
- Presence of a condition or abnormality that in the opinion of the investigator would
compromise the safety of the patient of the quality of the data.
Age minimum:
40 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Idiopathic Pulmonary Fibrosis
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Interstitial Lung Disease
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IPF
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Intervention(s)
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Drug: Dabigatran
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Radiation: FDG PET scan
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Primary Outcome(s)
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Demonstrate a change in FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) avidity
[Time Frame: Approximately 4 weeks]
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Secondary Outcome(s)
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Demonstrate changes in various coagulation factors
[Time Frame: Approximately 4 weeks]
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Secondary ID(s)
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IRAS191454
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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