A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF Genotypes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04545515|
Recruitment Status : Active, not recruiting
First Posted : September 11, 2020
Last Update Posted : February 7, 2022
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: ELX/TEZ/IVA Drug: IVA||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3b Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)|
|Actual Study Start Date :||January 11, 2021|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2023|
Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening.
Fixed dose combination (FDC) tablet for oral administration.
Tablet for oral administration.
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to Week 100 ]
- Absolute Change in Sweat Chloride (SwCl) [ Time Frame: From Baseline up to Week 96 ]
- Absolute Change in Lung Clearance Index 2.5 (LCI 2.5) [ Time Frame: From Baseline up to Week 96 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04545515