Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
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|ClinicalTrials.gov Identifier: NCT04058366|
Recruitment Status : Active, not recruiting
First Posted : August 15, 2019
Last Update Posted : January 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: ELX/TEZ/IVA Drug: IVA||Phase 3|
Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||251 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)|
|Actual Study Start Date :||December 5, 2019|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2022|
Experimental: Triple Combination Arm
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.
150-mg 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 Baseline up to Week 100 ]
- Absolute change in percent predicted forced expiratory volume in 1 second (ppFEV1) [ Time Frame: From Baseline up to Week 96 ]
- Absolute change in sweat chloride (SwCl) [ Time Frame: From Baseline up to Week 96 ]
- Absolute change in body mass index (BMI) [ Time Frame: From Baseline up to Week 96 ]
- Absolute change in BMI z-score [ Time Frame: From Baseline up to Week 96 ]
- Absolute change in body weight [ Time Frame: From Baseline up to Week 96 ]
- Absolute change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain score [ 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): NCT04058366