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VX-121 Combination Therapy for Cystic Fibrosis
Study Summary
This trial will test the efficacy and safety of VX-121/tezacaftor/deutivacaftor in CF patients who have one F508del mutation and one minimal function mutation.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have a lung infection caused by certain germs that can make your breathing get worse quickly.You have severe liver problems or high blood pressure in the liver.Your lung function, measured by FEV1, should be between 40% and 80% if you are not currently taking ELX/TEZ/IVA.Your lung function, measured by FEV1, should be between 40% and 90% of the expected value based on your age, sex, and height if you are taking ELX/TEZ/IVA therapy.You have received a transplant for an organ or blood-related condition.You have a specific combination of genetic mutations called F508del and minimal function mutation.
- Group 1: VX-121/TEZ/D-IVA
- Group 2: ELX/TEZ/IVA
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What other research has been conducted with VX-121/TEZ/D-IVA?
"At the moment, there are 15 VX-121/TEZ/D-IVA trials in Phase 3 and 22 live studies being conducted in total. Most of these VX-121/TEZ/D-IVA trials are based in Bochum and California, but there are 1038 clinical trial sites for VX-121/TEZ/D-IVA in total."
Could you please tell me how many hospitals are participating in this research project?
"There are a total of 69 sites running this clinical trial, with convenient locations in Cleveland, Toledo, and Lexington. By enrolling at the location closest to you, you can help minimize travel demands."
Could you please give an estimate of the total amount of people who have agreed to participate in this clinical trial?
"The sponsor, Vertex Pharmaceuticals Incorporated, needs to recruit 400 patients that meet the eligibility for the study from multiple sites. These sites include Cleveland Clinic CF in Cleveland, Ohio and ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic fibrosis Center in Toledo, Kentucky."
Are there other similar trials to this one that have been conducted in the past?
"There are 22 ongoing clinical trials for VX-121/TEZ/D-IVA in 23 countries and 110 cities. The first trial was sponsored by Vertex Pharmaceuticals Incorporated and completed its Phase 3 in 2015. A total of 1044 patients were involved. 86 clinical trials have been conducted since then."
Does VX-121/TEZ/D-IVA have FDA approval for therapeutic use?
"VX-121/TEZ/D-IVA's safety is supported by clinical data, making it a 3 on our 1-3 scale."
What are the VX-121/TEZ/D-IVA treatments commonly used to target?
"VX-121/TEZ/D-IVA is most commonly used to treat patients that have the homozygous for f508del mutation in the cftr gene. However, it has also been used to ameliorate symptoms in cystic fibrosis (cf), cystic fibrosis, homozygous for the f508del cftr mutation, and ivacaftor-responsive cftr mutation patients."
Are patients being recruited for this trial at this time?
"The correct, as detailed on clinicaltrials.gov, this research is actively recruiting patients. The original posting date was September 14th, 2021 and the most recent update was October 10th, 2022. 400 individuals are needed for the research to be conducted across 69 sites."
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