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)
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT06962852
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 285
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Occurrence of treatment-emergent delayed adverse events (AEs) up to 15 years 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
- Secondary Outcome Measures
Name Time Method 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) up to 15 years Time to first pulmonary exacerbation (PEX) from last dosing up to 15 years Occurrence of AEs up to 2 years after enrolment up to 2 years Occurrence of serious adverse events (SAEs) throughout the study up to 15 years Occurrence of replication-competent lentivirus (RCL) throughout the study up to 15 years
Trial Locations
- Locations (10)
Istituto G. Gaslini
🇮🇹Genova, Italy
HOP Necker
🇫🇷Paris, France
Osp. Pediatrico Bambin Gesù
🇮🇹Roma, Italy
HOP Gui de Chauliac
🇫🇷Montpellier, France
Universitair Medisch Centrum Utrecht
🇳🇱Utrecht, Netherlands
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
University Hospital Llandough
🇬🇧Cardiff, United Kingdom
Royal Brompton Hospital
🇬🇧London, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom