This study is for people with cystic fibrosis who took part in a previous study with a medicine called BI 3720931. The main purpose of this study is to monitor the long-term health of participants who were treated with BI 3720931 in the previous study. Participants in this study do not receive additional treatment with BI 3720931. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
5
BI 3720931
Hôpital Gui de Chauliac
Montpellier, France
Osp. Pediatrico Bambin Gesù
Roma, Italy
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Royal Brompton Hospital
London, United Kingdom
Occurrence of treatment-emergent delayed adverse events (AEs)
Treatment-emergent delayed AEs are defined as new malignancies, new serious neurologic disorders, new serious rheumatologic or autoimmune disorders, new serious hematologic disorders, or new serious potentially product-related infections, until 15 years from enrolment
Time frame: up to 15 years
Time to loss of efficacy defined as the drop to below 5% (absolute) above baseline in forced expiratory volume in 1 second, percent of predicted value (FEV1pp)
Time frame: up to 15 years
Time to first pulmonary exacerbation (PEX) from last dosing
Time frame: up to 15 years
Occurrence of AEs up to 2 years after enrolment
Time frame: up to 2 years
Occurrence of serious adverse events (SAEs) throughout the study
Time frame: up to 15 years
Occurrence of replication-competent lentivirus (RCL) throughout the study
Time frame: up to 15 years
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