A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy
|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: NCT04362761|
Recruitment Status : Active, not recruiting
First Posted : April 27, 2020
Last Update Posted : August 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: ELX/TEZ/IVA Drug: IVA||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||172 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3b Open-label Extension Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects|
|Actual Study Start Date :||May 4, 2020|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
Subjects will receive ELX/TEZ/IVA TC in the morning and IVA as mono tablet in the evening.
Fixed-dose combination (FDC) tablet for oral administration.
Mono tablet for oral administration.
- Safety and tolerability as assessed by number of subjects with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: From Day 1 up to Week 52 ]
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): NCT04362761