A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
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ClinicalTrials.gov Identifier: NCT03525574 |
Recruitment Status :
Active, not recruiting
First Posted : May 15, 2018
Last Update Posted : July 27, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cystic Fibrosis | Drug: VX-445 Drug: TEZ 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 : | 507 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-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation |
Actual Study Start Date : | October 9, 2018 |
Estimated Primary Completion Date : | January 2023 |
Estimated Study Completion Date : | January 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Open-label Triple Combination
Subjects will receive 200 mg VX-445/ 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-445 in combination with TEZ and IVA. This includes Studies VX17-445-102 and VX17-445-103. |
Drug: VX-445
Fixed-dose combination (FDC) tablets (VX-445/TEZ/IVA) Drug: TEZ FDC tablets (VX-445/TEZ/IVA)
Other Name: tezacaftor; VX-661 Drug: IVA FDC tablets (VX-445/TEZ/IVA)
Other Name: ivacaftor; VX-770 Drug: IVA IVA tablet
Other Name: ivacaftor; VX-770 |
- Safety and tolerability as assessed by number of subjects with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: from baseline through safety follow-up (up to 196 weeks) ]
- Absolute change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV1) [ Time Frame: from baseline through last dose of study drug (up to 192 weeks) ]
- Absolute change in sweat chloride (SwCl) [ Time Frame: from baseline through last dose of study drug (up to 192 weeks) ]
- Number of pulmonary exacerbations (PEx) [ Time Frame: from baseline through last dose of study drug (up to 192 weeks) ]
- Time to first PEx [ Time Frame: from baseline through last dose of study drug (up to 192 weeks) ]
- Absolute change in body mass index (BMI) [ Time Frame: from baseline through last dose of study drug (up to 192 weeks) ]
- Absolute change in BMI z-score [ Time Frame: from baseline through last dose of study drug (up to 192 weeks) ]
- Absolute change in body weight [ Time Frame: from baseline through last dose of study drug (up to 192 weeks) ]
- Absolute change from baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain score [ Time Frame: from baseline through last dose of study drug (up to 192 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): NCT03525574

Responsible Party: | Vertex Pharmaceuticals Incorporated |
ClinicalTrials.gov Identifier: | NCT03525574 |
Other Study ID Numbers: |
VX17-445-105 2018-000185-11 ( EudraCT Number ) |
First Posted: | May 15, 2018 Key Record Dates |
Last Update Posted: | July 27, 2022 |
Last Verified: | July 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Cystic Fibrosis Fibrosis 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 |