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Clinical trial

Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age

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Last updated:2nd Oct 2018
Identifier: NCT03691779

This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-445, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects 6 through 11 years of age with F/F and F/MF genotypes.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 56 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age
Actual Study Start Date: October 2, 2018
Estimated Primary Completion Date: January 2020
Estimated Study Completion Date: January 2020

Arms:
- Experimental:
Part A: Triple Combination
Subjects will receive 100 mg VX-445/ 50 mg TEZ/ 75 mg IVA as an FDC tablet in the morning and 75 mg IVA as mono tablet in the evening.
- Experimental: Part B: Triple Combination
Subjects will receive VX-445/TEZ/IVA as FDC tablet in the morning and IVA as mono tablet in the evening with the dose to be based on the outcome of Part A.

Category Value
Date last updated at source 2018-11-02
Study type(s) Interventional
Expected enrolment 56
Study start date 2018-10-02
Estimated primary completion date 2020-01-01

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