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CFTR Modulator

Triple Combination Therapy for Cystic Fibrosis

Q: What perils are associated with the application of VNZ/TEZ/D-IVA to patients?

<p>Our team at Power gave VNZ/TEZ/D-IVA a rating of 3 due to the large body of evidence from its Phase 3 trial, indicating both efficacy and safety.</p>

Q: Are participants currently being sought out for this experiment?

<p>According to the details presented on clinicaltrials.gov, this experiment is not accepting applicants at present. It was initially made available on August 11th 2023 but had its most recent update on August 25th of that year. Although there are no current openings for participation in this trial, 426 other studies have open recruitment periods.</p>

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 day 1 up to week 100

Awards & highlights

Study Summary

This trial looks at how safe, tolerated and effective a medicine is for people with cystic fibrosis over the long-term.

Who is the study for?

This trial is for people with cystic fibrosis who finished treatment in a previous study (VX21-121-105). It's not open to those who've had organ transplants, cancer, drug intolerance during the prior study, or serious liver issues like cirrhosis with portal hypertension.Check my eligibility

What is being tested?

The trial tests the long-term safety and effectiveness of a combination medication called vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) for individuals with cystic fibrosis.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones associated with CF treatments may include chest discomfort, coughing, digestive changes, and potential liver problems. The exact side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 up to week 100

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 up to week 100

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 up to week 100 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)

Secondary outcome measures

All Cohorts: Absolute Change in Sweat Chloride (SwCl)

All Cohorts: Absolute Change in Weight

All Cohorts: Change in Weight-for-age Z-score

+12 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: VNZ/TEZ/D-IVAExperimental Treatment1 Intervention

Participants (Cohort 1: 6 through 11 years of age (inclusive); Cohort 2: 2 through 5 years of age (inclusive) and Cohort 3: 1 to less than (<) 2 years of age) will receive VNZ/TEZ/D-IVA once daily at doses determined based on their age and weight. The age range is based on date of informed consent in parent study.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor

243 Previous Clinical Trials

32,207 Total Patients Enrolled

126 Trials studying Cystic Fibrosis

17,569 Patients Enrolled for Cystic Fibrosis

Media Library

Vanzacaftor/Tezacaftor/Deutivacaftor (CFTR Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05844449 — Phase 3

Cystic Fibrosis Research Study Groups: VNZ/TEZ/D-IVA

Cystic Fibrosis Clinical Trial 2023: Vanzacaftor/Tezacaftor/Deutivacaftor Highlights & Side Effects. Trial Name: NCT05844449 — Phase 3

Vanzacaftor/Tezacaftor/Deutivacaftor (CFTR Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05844449 — Phase 3

Frequently Asked Questions

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

What perils are associated with the application of VNZ/TEZ/D-IVA to patients?

"Our team at Power gave VNZ/TEZ/D-IVA a rating of 3 due to the large body of evidence from its Phase 3 trial, indicating both efficacy and safety."

Answered by AI

Are participants currently being sought out for this experiment?

"According to the details presented on clinicaltrials.gov, this experiment is not accepting applicants at present. It was initially made available on August 11th 2023 but had its most recent update on August 25th of that year. Although there are no current openings for participation in this trial, 426 other studies have open recruitment periods."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older

2023. "Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05844449.

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