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CFTR Modulator

TEZ/IVA for Cystic Fibrosis

Phase 3
Waitlist Available
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from parent study 115 baseline at week 96 (study 116)
Awards & highlights

Study Summary

This trial will study the long-term effects of a drug combination for cystic fibrosis. The drug combo is safe and tolerable for people aged 6+.

Eligible Conditions
  • Cystic Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from parent study 115 baseline at week 96 (study 116)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from parent study 115 baseline at week 96 (study 116) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary outcome measures
Part A: Absolute Change in BMI for 113B/116 FAS
Part A: Absolute Change in Body Mass Index (BMI) for 115/116 FAS (TEZ/IVA Group)
Part A: Absolute Change in CFQ-R Respiratory Domain Score for 113B/116 FAS
+5 more

Side effects data

From 2020 Phase 3 trial • 271 Patients • NCT04058353
15%
Headache
14%
Cough
8%
Infective pulmonary exacerbation of cystic fibrosis
7%
Nausea
6%
Sputum increased
6%
Diarrhoea
2%
Abdominal pain
1%
Depression
1%
Anxiety
1%
Haemoptysis
1%
Hyperparathyroidism primary
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control: IVA or TEZ/IVA
TC: ELX/TEZ/IVA

Trial Design

1Treatment groups
Experimental Treatment
Group I: TEZ/IVAExperimental Treatment2 Interventions
TEZ 50 mg once daily (qd)/IVA 75 mg every 12 hours (q12h) or TEZ 100 mg qd/IVA 150 mg q12h based on body weight for participants aged 6 through 11 years at enrollment and TEZ 100 mg qd/IVA 150 mg q12h for participants aged >=12 years at enrollment. Doses were adjusted upward for changes in body weight and/or age.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IVA
2018
Completed Phase 3
~5230
Tezacaftor
FDA approved

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
243 Previous Clinical Trials
32,257 Total Patients Enrolled
126 Trials studying Cystic Fibrosis
17,619 Patients Enrolled for Cystic Fibrosis

Media Library

IVA (CFTR Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT03537651 — Phase 3
Cystic Fibrosis Research Study Groups: TEZ/IVA
Cystic Fibrosis Clinical Trial 2023: IVA Highlights & Side Effects. Trial Name: NCT03537651 — Phase 3
IVA (CFTR Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03537651 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are they recruiting new participants for this research program at this time?

"Although this particular clinical trial is not presently looking for new participants, this may be due in part to the fact that it was initially posted over 4 years ago. The data on clinicaltrials.gov was last updated on October 28th, 2022. There are presently 451 other trials that are actively enrolling patients."

Answered by AI

What are the most serious risks associated with TEZ/IVA?

"There is some clinical data supporting TEZ/IVA's efficacy and multiple rounds of data suggesting it is safe, so it received a score of 3."

Answered by AI

Is this the first time TEZ/IVA has been trialed?

"TEZ/IVA was first studied in 2015 in a clinical trial registered under NCT02565914. As of now, there are 85 completed trials and 22 live clinical trials. Many of these ongoing trials are being conducted in Charleston, South carolina."

Answered by AI

What indications typically lead to a prescription for TEZ/IVA?

"The genetic condition cystic fibrosis, specifically when homozygous for the f508del cftr mutation, can be improved by TEZ/IVA treatment."

Answered by AI

Have any other medical trials like this been conducted in the past?

"Vertex Pharmaceuticals Incorporated's clinical trial, which completed its Phase 3 drug approval in 2015, was the first study conducted for TEZ/IVA. Since then, 85 other trials have been completed for the TEZ/IVA medication in 23 countries and 110 cities."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects With an F508del CFTR Mutation
2018. "A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects With an F508del CFTR Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03537651.
~19 spots leftby Apr 2025
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