A Study Evaluating the Long-term Safety of VX-445 Combination Therapy

Vertex Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Cystic Fibrosis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04043806

2018-004652-38 (EudraCT Number)

VX18-445-113

Details and patient eligibility

About

This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).

Enrollment: 458 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Currently participating in study VX17-659-105 (NCT03447262)

Exclusion criteria

• History of drug intolerance in study VX17-659-105 that would pose an additional risk to the participant in the opinion of the investigator
• Current participation in an investigational drug trial (other than study VX17-659-105)

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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458 participants in 1 patient group

ELX/TEZ/IVA

Experimental group

Description:

Part A: Participants received ELX 200 milligram (mg) once daily (qd),TEZ 100 mg qd, and IVA 150 mg every 12 hours (q12h) in the treatment period for 96 weeks. Part B: Participants from certain countries participated in Part B and continued to received ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.

Treatment:

Drug: IVA

Drug: ELX/TEZ/IVA