|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
4 January 2022 |
|
Main ID: |
NCT03475381 |
|
Date of registration:
|
04/01/2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Real-life Follow-up of Cystic Fibrosis Patients Treated With Ivacaftor+Lumacaftor (Orkambi*)
ORKAMBI |
|
Scientific title:
|
Real-life Follow-up of Cystic Fibrosis Patients Treated With Ivacaftor+Lumacaftor (Orkambi*) |
|
Date of first enrolment:
|
January 22, 2016 |
|
Target sample size:
|
852 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03475381 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Pierre-Regis BURGEL, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hôpitaux Universitaire Paris Centre, AP-HP |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patient aged 12 years or older.
- Patient with Cystic Fibrosis with presence of two mutations DF508 in the CFTR gene
- Patient treated with ivacaftor+lumacaftor (Orkambi)
Exclusion Criteria:
- Refusal to participate in the study
- Start of Orkambi as part of a clinical trial
Age minimum:
12 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Cystic Fibrosis
|
|
Intervention(s)
|
|
Drug: Ivacaftor+lumacaftor
|
|
Primary Outcome(s)
|
|
Causes of treatment discontinuation
[Time Frame: 1 year]
|
|
Timing of treatment discontinuation
[Time Frame: 1 year]
|
|
Rates of treatment discontinuation
[Time Frame: 1 year]
|
|
Secondary Outcome(s)
|
|
Forced expiratory volume in 1 sec (FEV1)
[Time Frame: 1 year]
|
|
Pulmonary exacerbations
[Time Frame: 1 year]
|
|
Body mass index
[Time Frame: 1 year]
|
|
Forced vital capacity (FVC)
[Time Frame: 1 year]
|
|
Chloride concentration
[Time Frame: 1 year]
|
|
Secondary ID(s)
|
|
NI17043HLJ
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|