A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy
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ClinicalTrials.gov Identifier: NCT03447262 |
Recruitment Status :
Completed
First Posted : February 27, 2018
Last Update Posted : October 9, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cystic Fibrosis | Drug: VX-659 Drug: TEZ Drug: IVA | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 484 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Open-label Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation |
Actual Study Start Date : | July 13, 2018 |
Actual Primary Completion Date : | September 9, 2020 |
Actual Study Completion Date : | September 9, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Open-label triple combination
Subjects will receive 240 mg VX-659 / 100 mg TEZ / 150 mg IVA as FDC tablets in the morning and 150 mg IVA as mono tablet in the evening. Parent studies are Phase 3 Vertex studies investigating VX-659 in combination with TEZ and IVA. This includes Studies VX17-659-102 and VX17-659-103. |
Drug: VX-659
Fixed-dose combination (FDC) tablets (VX-659/TEZ/IVA) Drug: TEZ FDC tablets (VX-659/TEZ/IVA)
Other Name: tezacaftor; VX-661 Drug: IVA FDC tablets (VX-659/TEZ/IVA)
Other Name: ivacaftor; VX-770 Drug: IVA IVA tablet
Other Name: ivacaftor |
- Safety and tolerability of long-term treatment with VX-659 in TC with TEZ and IVA based on adverse events (AEs) [ Time Frame: from baseline through safety follow-up (up to 100 weeks) ]
- Absolute change from baseline in ppFEV1 [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
- Absolute change in sweat chloride (SwCl) [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
- Number of pulmonary exacerbations (PEx) [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
- Time to first PEx [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
- Absolute change in body mass index (BMI) [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
- Absolute change in BMI z-score [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
- Absolute change in body weight [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]
- Absolute change from baseline in CFQ-R respiratory domain score [ Time Frame: from baseline through last dose of study drug (up to 96 weeks) ]

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Completed study drug treatment in a parent study; or had study drug interruption(s) in a parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study.
Exclusion Criteria:
- History of drug intolerance in a parent study that would pose an additional risk to the subject in the opinion of the investigator.
- Current participation in an investigational drug trial (other than a parent study)
Other protocol defined Inclusion/Exclusion criteria may apply.

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): NCT03447262

Responsible Party: | Vertex Pharmaceuticals Incorporated |
ClinicalTrials.gov Identifier: | NCT03447262 |
Other Study ID Numbers: |
VX17-659-105 2017-004134-29 ( EudraCT Number ) |
First Posted: | February 27, 2018 Key Record Dates |
Last Update Posted: | October 9, 2020 |
Last Verified: | October 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Cystic Fibrosis Fibrosis VX-659 Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Ivacaftor Chloride Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |