Clinical trial for Cystic Fibrosis (CF)
Official title Ensuring Access to Optimal Therapy in CF: The ENACT Study
ClinicalTrials.gov ID: NCT07148739
What this study is testing
What is Elexacaftor / Ivacaftor / Tezacaftor?
Elexacaftor / Ivacaftor / Tezacaftor is an investigational medicine, being studied as a potential treatment for cystic fibrosis (cf).
Also referred to as Triple Combination CFTR Modulator Therapy, ETI - Elexacaftor/Tezacaftor/Ivacaftor.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing how new drugs work in the body. It also looks at genes to see who might benefit most.
- Who it's for
- You may be able to join if you are a child with cystic fibrosis.
- What's involved
- You would take new medicines. The team will check your genes and how your body handles the drugs.
- Time commitment
- The source text does not say how long the study lasts or what visits are needed.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 and older
You may be able to join if
- documentation of CF diagnosis per CFF diagnostic criteria and known CFTR genotype
- age 2 years and older
- ability to provide written informed consent and/or assent (by subject and/or legal guardian)
- on a stable dose of triple combination CFTR modulator therapy for at least two weeks prior to Visit 1
- clinically stable lung disease, defined as no documented acute decrease in FEV1 \> 10%, OR use of additional antibiotics (intravenous [IV] or oral...
You likely can't join if
- recent significant unintentional weight loss, as determined by the investigator, in the 4 weeks prior to screening
- pregnant or breastfeeding female
- history of alcohol or substance abuse in the 6 months prior to screening
- participation in a study involving an investigational intervention within 28 days (or 5 half-lives, whichever is longer) prior to screening
- in the opinion of the Investigator, medical or psychiatric illness, or other conditions that would interfere with participation
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Little Rock, Arkansas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Little Rock, Arkansas, United States; Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.