- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04019080
Real-Life Use of Anti-fibrotic Drugs in Patients With Idiopathic Pulmonary Fibrosis in Sweden
July 11, 2019 updated by: Magnus Skold, Karolinska University Hospital
The objective of the current research project is, by using high quality Swedish registry data, to evaluate use, tolerance and effect of anti-fibrotic drugs in IPF-patients.
Secondary study objectives are to determine the clinical profile, determinants of treatment adherence, long-term safety and to describe the patient journey from the first sign of disease to end of treatment.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carlson, RN
- Phone Number: +46737121597
- Email: lisa.carlson@sll.se
Study Contact Backup
- Name: Sköld, Prof
- Email: magnus.skold@ki.se
Study Locations
-
-
-
Stockholm, Sweden
- Recruiting
- Karolinska University Hospital
-
Contact:
- Carlson, RN
- Phone Number: +46737121597
- Email: lisa.carlson@sll.se
-
Contact:
- Sköld, Prof
- Email: magnus.skold@ki.se
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with idiopathic pulmonary fibrosis included in the Swedish IPF-registry
Description
Inclusion Criteria:
- All subjects included in the Swedish IPF-registry
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-fibrotic drugs among the patients recorded in the Swedish IPF-registry
Time Frame: 2014-2020
|
The use of anti-fibrostic drugs
|
2014-2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
July 11, 2019
First Submitted That Met QC Criteria
July 11, 2019
First Posted (Actual)
July 15, 2019
Study Record Updates
Last Update Posted (Actual)
July 15, 2019
Last Update Submitted That Met QC Criteria
July 11, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 180293
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Idiopathic Pulmonary Fibrosis
-
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Wake Forest University Health SciencesMayo Clinic; The University of Texas Health Science Center at San AntonioCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
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Theravance BiopharmaTerminatedIdiopathic Pulmonary Fibrosis (IPF)United Kingdom
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University of California, San FranciscoCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
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BiogenCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
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Liminal BioSciences Ltd.CompletedIdiopathic Pulmonary Fibrosis (IPF)Canada
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Bristol-Myers SquibbCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
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