Is NCT06683092 recruiting in Aurora, CO?

Yes, NCT06683092 is currently recruiting participants at its Aurora, CO location. This cystic fibrosis clinical trial is actively enrolling qualified participants.

How do I join the cystic fibrosis clinical trial in Aurora?

To join this clinical trial in Aurora, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Aurora clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Cystic Fibrosis Clinical Trial in Aurora, CO

About This Cystic Fibrosis Study in Aurora

RETRIAL is a multi-site observational study of people with Cystic Fibrosis (PWCF) ages 6 and up starting the new triple-therapy modulator (vanzacaftor/tezacaftor/deutivacaftor (VTD)), after having experienced neuropsychiatric events and/or liver injury while taking elexacaftor/tezacaftor/ivacaftor (ETI) that resulted in a modification or discontinuation of standard ETI dosing.

Sponsor: Boston Children's Hospital

Who Can Participate

Inclusion Criteria

RETRIAL-Mental Health:

PWCF age 6 years and up (if age is \< 12 years old, the PWCF's caregiver will complete daily diaries and surveys; see "Caregiver Participant Inclusion Criteria" below)

Eligible for VTD and intending to take it

Experienced new or worsening mental health symptoms after initiating ETI, which led to one of the following changes in treatment to currently taking:

No modulators

A modulator other than ETI

A flipped dose of ETI

A reduced dose of ETI

Willing to delay first VTD dose for short period of time to complete the Baseline assessments

Has access to a smart device (phone, tablet, etc.) capable of receiving messages with survey links

Is English-speaking. RETRIAL-LIVER:

A person with CF age 6 years and up

Eligible for VTD and intending to take it

Experienced drug-induced liver injury (as defined by local care team) after initiating ETI, which led to one of the following changes in treatment to currently taking:

no modulators; or

a modulator other than ETI; or

a reduced or altered dose of ETI;

Willing to delay first VTD dose for short period of time to complete the Baseline assessments

Has access to a smart device (phone, tablet, etc.) capable of receiving messages with survey links

Is English-speaking.

Exclusion Criteria

RETRIAL-Mental Health:

Cannot access VTD

Currently, or prior history of, taking VTD

Unable or unwilling to follow protocol

If \<12 years old, having another \<12-year-old person in the same household consented into the study

Is actively listed on any transplant list, or within 3 months post-transplant surgery

Is currently pregnant (test not required)

Anticipated change in CF Care Centers in the next 6 months

Any situation that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. RETRIAL-LIVER:

Cannot access VTD

Currently, or prior history of, taking VTD

Unable or unwilling to follow protocol

If \<12 years old, having another \<12-year-old person in the same household consented into the study

Any severe, decompensated liver disease (e.g. Child-Pugh, Class C)

Is actively listed on any transplant list, or within 3 months post-transplant surgery (any organ), or history of liver transplant

Is currently pregnant (test not required)

Anticipated change in CF Care Centers in the next 6 months

Any situation that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. Caregiver Participant: Inclusion Criteria:

Is a primary, daily caregiver of a person with CF under the age of 12 enrolled in the study

Has access to smart device (phone, tablet, etc.) capable of receiving messages with survey links

Is able to read and complete surveys and Daily Diary in English. Exclusion Criteria: \- Any situation that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Aurora?

Yes, this clinical trial (NCT06683092) has an active research site in Aurora, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Cystic Fibrosis Treatment Options in Aurora, CO

If you're searching for cystic fibrosis treatment options in Aurora, CO, this clinical trial (NCT06683092) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Aurora research site is actively enrolling participants for this clinical trial. You'll receive care from experienced cystic fibrosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cystic fibrosis clinical trials near you to find additional studies recruiting in your area.

Cystic Fibrosis Clinical Trial in Aurora, CO

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