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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504909-37-00 | Registry Identifier | CTIS | |
| U1111-1291-2932 | Registry Identifier | WHO - International Clinical Trials Registry Platform (ICTRP) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All trial participants | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 3720931 | Genetic | BI 3720931 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
There are no exclusion criteria for enrolment into the trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Gui de Chauliac | Montpellier | 34295 | France | |||
| Osp. Pediatrico Bambin Gesù |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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The trial is intended to assess 2 different objectives: long-term safety over 15 years and durability of efficacy over at least 2 years of BI 3720931 after single dose administration in a previous clinical trial in trial participants with cystic fibrosis (CF).
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| 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 |
| Roma |
| 00165 |
| Italy |
| Universitair Medisch Centrum Utrecht | Utrecht | 3584 CX | Netherlands |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Royal Brompton Hospital | London | SW3 6JY | United Kingdom |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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