A Long-term Study to Monitor the Health Status of People With Cystic Fibrosis Who Took Part in a Previous Study With BI 3720931 (Lenticlair™-ON)
NCT ID: NCT06962852
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
285 participants
INTERVENTIONAL
2025-05-20
2048-11-24
Brief Summary
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Participants who previously took BI 3720931 are in this study for 15 years. Participants who previously took placebo are in the study only until it is disclosed that they were in the placebo group, after which they stop. Participants who previously took BI 3720931 visit the study site about 20 times. Participants visit once every 3 months during the first 2 years.
After that, they visit once a year. During study visits, doctors check the health of the participants and note any health problems that could have been caused by BI 3720931. They also do lung function tests to see if BI 3720931 helps people with cystic fibrosis in the long term.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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All trial participants
All trial participants who have received at least one dose of BI 3720931 or matching placebo in a previous trial with BI 3720931.
Trial participants who received placebo in the previous trial do not need to be followed for 15 years; once the treatment in the previous trial has been unblinded, their participation in this trial is then terminated.
BI 3720931
BI 3720931
Interventions
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BI 3720931
BI 3720931
Eligibility Criteria
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Inclusion Criteria
2. Signed and dated written informed consent in accordance with International Council for Harmonisation (ICH)-Good Clinical Practice (GCP) and local legislation prior to admission to the trial
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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HOP Gui de Chauliac
Montpellier, , France
HOP Necker
Paris, , France
Istituto G. Gaslini
Genova, , Italy
Osp. Pediatrico Bambin Gesù
Roma, , Italy
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Hospital Universitari Vall D Hebron
Barcelona, , Spain
University Hospital Llandough
Cardiff, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Related Links
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Related Info
Other Identifiers
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2023-504909-37-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1291-2932
Identifier Type: REGISTRY
Identifier Source: secondary_id
1504-0003
Identifier Type: -
Identifier Source: org_study_id