← Back to Search

CFTR Modulator

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 baseline at study 110 week 96

Awards & highlights

Study Summary

This trial is testing the safety and efficacy of VX-661 in combination with ivacaftor for the treatment of cystic fibrosis. The trial is open label, meaning that participants and researchers will know which treatments are being given. The trial is for subjects who have already participated in other studies and who have the F508del-CFTR mutation.

Eligible Conditions

Cystic Fibrosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline at study 110 week 96

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline at study 110 week 96

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline at study 110 week 96 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)

Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs

Part C: 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 From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score for 108/110 Efficacy Set

Part A: Absolute Change in BMI Z-score for 106/110 Efficacy Set

Part A: Absolute Change in BMI Z-score for 108/110 Efficacy Set

+31 more

Side effects data

From 2022 Phase 3 trial • 458 Patients • NCT04043806

25%

Cough

23%

Infective pulmonary exacerbation of cystic fibrosis

20%

Headache

16%

Upper respiratory tract infection

15%

Sputum increased

14%

Pyrexia

13%

Oropharyngeal pain

13%

Nasopharyngitis

11%

Nasal congestion

10%

Fatigue

10%

Viral upper respiratory tract infection

Nausea

Immunisation reaction

Alanine aminotransferase increased

Blood creatine phosphokinase increased

Haemoptysis

Rhinorrhoea

Abdominal pain

Diarrhoea

COVID-19

Sinusitis

Aspartate aminotransferase increased

Back pain

Arthralgia

Dyspnoea

Productive cough

Sinus congestion

Rash

Vomiting

Pain

Myalgia

Respiration abnormal

Pneumonia

Distal intestinal obstruction syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Part A: ELX/TEZ/IVA

Part B: ELX/TEZ/IVA

Trial Design

1Treatment groups

Experimental Treatment

Group I: TEZ/IVAExperimental Treatment2 Interventions

Part A: Participants who received either TEZ/IVA, IVA monotherapy or Placebo in parent studies 103,106,107,108,109 and 111 were administered TEZ 100 milligram (mg)/IVA 150 mg fixed-dose tablet in the morning and IVA 150 mg mono tablet in the evening for 96 weeks. Part B: Participants who received either TEZ/IVA, IVA monotherapy or Placebo in parent studies 106,108,109,112 and 114 were administered TEZ 100 mg/IVA 150 mg fixed-dose tablet in the morning and IVA 150 mg mono tablet in the evening for 96 weeks. Part C: Participants who received TEZ/IVA, IVA monotherapy or Placebo in parent studies 106,108, and 114 were administered TEZ 100 mg/IVA 150 mg fixed dose tablet in the morning and IVA 150 mg mono tablet in the evening for 192 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IVA

2018

Completed Phase 3

~5230

TEZ/IVA

2018

Completed Phase 3

~2720

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

31,256 Total Patients Enrolled

126 Trials studying Cystic Fibrosis

16,618 Patients Enrolled for Cystic Fibrosis

Frequently Asked Questions

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

Are there any current openings for participants in this trial?

"Presently, this clinical trial is not searching for new patients. The date of the first posting was August 1st, 2015 and the most recent update occurred on May 6th, 2022. For those still seeking trials, there are 432 active studies involving cystic fibrosis and 22 IVA trials that are looking for participants."

Answered by AI

At how many hospitals is this clinical trial being conducted?

"This study is being conducted at 75 sites, with participating locations in Saint Louis, Cleveland, Miami and many other places. If you enroll as a patient, try to select a location near you to reduce travel time and costs."

Answered by AI

What are some common indications for IVA therapy?

"IVA is a medication used to treat cystic fibrosis in patients that have the f508del cftr mutation. Additionally, it can be used as treatment for conditions such as ivacaftor-responsive cftr mutation and homozygous for f508del mutation in the cftr gene."

Answered by AI

How many people have signed up to participate in this experiment?

"This study is not actively recruiting patients at the moment. The trial was initially posted on August 1st, 2015 and last updated on May 6th, 2022. However, there are currently 432 clinical trials seeking participants with cystic fibrosis and 22 studies for IVA that are still enrolling patients."

Answered by AI

Does the FDA sanction intravenous administration of this medication?

"Clinical data and multiple rounds of safety testing support IVA's efficacy, so it received a score of 3."

Answered by AI

What makes this particular clinical trial unique?

"22 clinical trials for IVA are ongoing in 23 countries and 110 cities as of now. The first trial started in 2015, completed Phase 3 drug approval in the same year, and was sponsored by Vertex Pharmaceuticals Incorporated. 1044 patients were involved. Since then, 85 similar studies have been successfully completed."

Answered by AI

Are there any other ongoing research projects that utilize IVA?

"There are currently 22 clinical trials underway that focus on IVA. Of these, 15 have reached Phase 3. Many of the research locations for this topic are in Bochum and California; though, there are a total of 1038 sites conducting IVA trials."

Answered by AI

Recent research and studies

The Lancet Respiratory MedicineJournal

Long-term Safety and Efficacy of Tezacaftor–ivacaftor in Individuals with Cystic Fibrosis Aged 12 Years or Older Who Are Homozygous or Heterozygous for Phe508del CFTR (EXTEND): An Open-label Extension Study

Flume, Patrick A, Reta Fischer Biner, Damian G Downey, Cynthia Brown, Manu Jain, Rainald Fischer, Kris De Boeck, et al.. 2021. “Long-term Safety and Efficacy of Tezacaftor–ivacaftor in Individuals with Cystic Fibrosis Aged 12 Years or Older Who Are Homozygous or Heterozygous for Phe508del CFTR (EXTEND): An Open-label Extension Study”. The Lancet Respiratory Medicine. Elsevier BV. doi:10.1016/s2213-2600(20)30510-5.

clinicaltrials.govStudy

A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR Mutation

2015. "A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02565914.