Monitoring the long-term health of cystic fibrosis patients who previously took BI 3720931
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 (Lenticlair™-ON)
This study is tracking the long-term health of people with cystic fibrosis who took the medication BI 3720931 in a previous trial to see how they are doing over the next 15 years.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 285 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boehringer Ingelheim Industry-sponsored |
| Locations | 10 sites (Montpellier and 9 other locations) |
| Trial ID | NCT06962852 on ClinicalTrials.gov |
What this trial studies
This study focuses on individuals with cystic fibrosis who participated in a prior trial involving the medication BI 3720931. The primary aim is to monitor their long-term health outcomes without administering additional treatment. Participants who received BI 3720931 will be followed for 15 years with regular health assessments, while those who received a placebo will be monitored until the disclosure of their treatment status. Health checks and lung function tests will be conducted to evaluate any potential long-term effects of the medication.
Who should consider this trial
Good fit: Ideal candidates are individuals with cystic fibrosis who previously participated in a trial involving BI 3720931.
Not a fit: Patients who did not participate in the previous study or did not receive BI 3720931 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effects of BI 3720931 on cystic fibrosis patients.
How similar studies have performed: Similar studies have shown promise in monitoring long-term health outcomes in chronic conditions, making this approach potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Trial participants who participated in a previous BI sponsored trial with BI 3720931 and have received any dose of BI 3720931, or matching placebo 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 There are no exclusion criteria for enrolment into the trial.
Where this trial is running
Montpellier and 9 other locations
- HOP Gui de Chauliac — Montpellier, France (Not_yet_recruiting)
- HOP Necker — Paris, France (Not_yet_recruiting)
- Istituto G. Gaslini — Genova, Italy (Not_yet_recruiting)
- Osp. Pediatrico Bambin Gesù — Roma, Italy (Not_yet_recruiting)
- Universitair Medisch Centrum Utrecht — Utrecht, Netherlands (Not_yet_recruiting)
- Hospital Vall d'Hebron — Barcelona, Spain (Not_yet_recruiting)
- University Hospital Llandough — Cardiff, United Kingdom (Not_yet_recruiting)
- Queen Elizabeth University Hospital — Glasgow, United Kingdom (Not_yet_recruiting)
- Royal Brompton Hospital — London, United Kingdom (Recruiting)
- Wythenshawe Hospital — Manchester, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Boehringer Ingelheim
- Email: clintriage.rdg@boehringer-ingelheim.com
- Phone: 1-800-243-0127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.