Idiopathic Pulmonary FibrosisNCT04019080
Real-Life Use of Anti-fibrotic Drugs in Patients With Idiopathic Pulmonary Fibrosis in Sweden
An observational study of Idiopathic Pulmonary Fibrosis, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Anti-fibrostic drugs
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2019to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with idiopathic pulmonary fibrosis included in the Swedish IPF-registry
Who may be able to join
- All subjects included in the Swedish IPF-registry
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Sköld, Prof contact
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm
Carlson, RN, +46737121597, lisa.carlson@sll.se
Sköld, Prof, magnus.skold@ki.se
About this study
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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Anti-fibrostic drugs
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-fibrostic drugsOther
The real-Life use of anti-fibrotic drugs in patients with idiopathic pulmonary fibrosis in Sweden
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-fibrotic drugs among the patients recorded in the Swedish IPF-registry
The use of anti-fibrostic drugs
Measured: 2014-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start1 Jan 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Skold, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019080
- Sponsor's protocol ID
- 180293
- Status last verified
- Jul 2019
- First submitted
- 11 Jul 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Life Use of Anti-fibrotic Drugs in Patients With Idiopathic Pulmonary Fibrosis in Sweden
- ClinicalTrials.gov ID
- NCT04019080
- Acronym / sponsor ID
- 180293
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with idiopathic pulmonary fibrosis included in the Swedish IPF-registry
Key inclusion criteria (1 listed)
- All subjects included in the Swedish IPF-registry
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-fibrostic drugsThe real-Life use of anti-fibrotic drugs in patients with idiopathic pulmonary fibrosis in Sweden | Other | – |
Primary outcome
Anti-fibrotic drugs among the patients recorded in the Swedish IPF-registry
Time frame: 2014-2020
The use of anti-fibrostic drugs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sköld, Prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlson, RN (+46737121597, lisa.carlson@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-fibrotic drugs among the patients recorded in the Swedish IPF-registry (time frame: 2014-2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.