ClinicalTrials.Veeva

Menu
The trial is taking place at:
S

St. James University Hospital | Oncology Clinical Research Facility

Veeva-enabled site

A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy

Vertex Pharmaceuticals logo

Vertex Pharmaceuticals

Status and phase

Active, not recruiting
Phase 3

Conditions

Cystic Fibrosis

Treatments

Drug: VX-121/TEZ/D-IVA

Study type

Interventional

Funder types

Industry

Identifiers

NCT05444257
VX20-121-104
2021-000713-17 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.

Enrollment

822 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Completed study drug treatment in a parent study VX20-121-102 (NCT05033080) and VX20-121-103 (NCT05076149); or had study drug interruption(s) in a parent study but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period in the parent study

Key Exclusion Criteria:

  • History of drug intolerance in a parent study
  • Pregnant or breast-feeding females

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)

822 participants in 1 patient group

VX-121/TEZ/D-IVA
Experimental group
Description:
Participants will receive VX-121/TEZ/D-IVA once daily.
Treatment:
Drug: VX-121/TEZ/D-IVA

Trial contacts and locations

195

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems