1504-0003: Long Term Follow up BI 3720931
Research type
Research Study
Full title
A clinical trial to evaluate the long-term safety and durability of efficacy of BI 3720931, an inhaled lentiviral vector gene therapy, after single dose administration in a previous clinical trial, in people with cystic fibrosis rolled-over from a previous clinical trial with BI 3720931 (LenticlairTM-ON).
IRAS ID
1008580
Contact name
Medical Information
Contact email
Sponsor organisation
Boehringer Ingelheim Limited
Research 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.
Some participants might receive additional treatment with BI 3720931. These participants will receive BI 3720931 by inhalation and complete procedures like those in the previous study.
Participants are in this study for 15 years. During the study, participants 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. The visits happen more often for participants who get additional treatment with BI 3720931. 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.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/LO/0108
Date of REC Opinion
26 Apr 2024
REC opinion
Further Information Favourable Opinion