Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and Older

Vertex Pharmaceuticals

Status and phase: Active, not recruiting; Phase 3

Conditions: Cystic Fibrosis

Treatments: Drug: ELX/TEZ/IVA; Drug: IVA

Study type: Interventional

Funder types: Industry

Identifiers

NCT05153317

VX20-445-112

2020-002239-31 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the long term safety, tolerability, efficacy and pharmacodynamics of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in CF participants 2 years of age and older.

Enrollment: 71 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

key Inclusion Criteria:

• Completed study drug treatment in the parent study (VX20-445-111 Part B, NCT04537793), or had study drug interruption(s) in the parent study, but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period of the parent study

Key Exclusion Criteria:

• History of study drug intolerance in the parent study
• History of poor compliance with ELX/TEZ/IVA and/or procedures in the parent study

Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

ELX/TEZ/IVA

Experimental group

Description:

Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening.

Treatment:

Drug: IVA

Drug: ELX/TEZ/IVA