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Observational Enrolling
An observational study for people with cystic fibrosis ages 6 and older who either changed how they took Trikafta (reduced or altered dose) or stopped taking Trikafta because of new or worsening mental health or cognitive symptoms, and/or liver injury and who plan to switch to Alyftrek. (RETRIAL)
This observational study will monitor the mental health and liver function of people with cystic fibrosis ages 6 and up who had to stop taking or change how they took Trikafta because of new or worsening mental health/cognitive symptoms (such as depression, anxiety, mood, sleep, and/or brain fog/memory problems) and/or liver symptoms (elevated liver enzymes), and who plan to start taking Alyftrek.
This study is observational, which means researchers observe participants on their current treatment plan and track health outcomes. To participate, people with CF need to enroll before they start taking Alyftrek. People need to receive the prescription from their CF doctor, because study researchers will not prescribe Alyftrek.
Researchers will collect information regarding changes in health, including mental health and liver health, both before participants start taking their clinically prescribed Alyftrek and for 12 months after.
This study may require questionnaires. In-person blood draws and other sample collections are optional.
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
6 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
This study is for people who previously took and then stopped taking or changed how they took elaxacaftor/tezacaftor/ivacaftor, and are now starting vanzacaftor/tezacaftor/deutivacaftor triple combination therapy.
Study Design
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Study Type: ?more info
Observational -
Randomized Study: ?more info
No -
Placebo Controlled: ?more info
No -
Length of Participation:
15 months -
Number of Study Visits:
2
Additional Information
-
Phase: ?more info
Phase Four/Post-Approval -
Study Sponsor: ?more info
Georgiopoulos, Anna -
Study Drugs:
N/A
Study Sites
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Enrolling
Alabama
The Children's Hospital Alabama, University of Alabama at Birmingham, Birmingham, AL 35233
Contact
Kathryn Monroe
Phone: +1 (205) 638-5599
Email: kathrynmonroe@uabmc.edu
-
Enrolling
Colorado
Children's Hospital Colorado, Aurora, CO 80045
Contact
Mary Cross
Phone: +1 (720) 777-4645
Email: mary.cross@childrenscolorado.org
-
Enrolling
Colorado
National Jewish Health, Denver, CO 80206
Contact
Alix Wilson
Phone: +1 (303) 270-2517
Email: wilsona@njhealth.org
-
Enrolling
Delaware
Alfred I. duPont Hospital for Children, Wilmington, DE 19803
Contact
Kimberly Renner
Phone: +1 (302) 651-6536
Email: Kimberly.renner@nemours.org
-
Enrolling
Florida
Nemours Children's Clinic - Jacksonville, Jacksonville, FL 32207
Contact
Jennifer (Jenn) Gafford
Phone: +1 (904) 697-3600
Email: Jennifer.gafford@nemours.org
-
Enrolling
Florida
The Nemours Children's Clinic - Orlando, Orlando, FL 32827
Contact
Sherry Wooldridge
Phone: +1 (407) 567-6206
Email: sherry.wooldridge@nemours.org
-
Enrolling
Florida
Nemours Children's Health - Pensacola, Pensacola, FL 32514
Contact
Rebecca Davis
Phone: +1 (850) 473-4553
Email: Rebecca.Davis@nemours.org
-
Enrolling
Georgia
Children’s Healthcare of Atlanta and Emory University, Atlanta, GA 30329
Contact
Ashleigh Streby
Phone: +1 (404) 727-0305
Email: ashleigh.streby@emory.edu
-
Enrolling
Indiana
Indiana University Medical Center, Indianapolis, IN 46202
Contact
Lisa Bendy
Phone: +1 (317) 278-7152
Email: lbendy@iu.edu
-
Enrolling
Kansas
University of Kansas Medical Center, Kansas City, KS 66160
Contact
Lawrence Scott
Phone: +1 (913) 588-4020
Email: lscott2@kumc.edu
-
Enrolling
Maryland
Johns Hopkins University, Baltimore, MD 21205
Contact
Jeanne Pinto
Phone: +1 (410) 955-9782
Email: jpinto4@jh.edu
-
Enrolling
Massachusetts
Boston Children's Hospital, Boston, MA 02115
Contact
Robert Fowler
Phone: +1 (617) 355-1834
Email: Robert.fowler@childrens.harvard.edu
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Enrolling Soon
Massachusetts
Massachusetts General Hospital, Boston, MA 02114
Contact
Margot Hardcastle
Phone: +1 (617) 726-3719
Email: mhardcastle@mgh.harvard.edu
-
Enrolling
Michigan
University of Michigan, Michigan Medicine, Ann Arbor, MI 48109
Contact
Dawn Kruse
Phone: +1 (734) 615-3266
Email: dmkruse@med.umich.edu
-
Enrolling
Missouri
St. Louis Children's Hospital, St. Louis, MO 63110
Contact
Irma Bauer
Phone: +1 (314) 747-2940
Email: irmabauer@wustl.edu
-
Enrolling
Pennsylvania
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA 15224
Contact
Adrienne DeRicco
Phone: +1 (412) 692-8069
Email: adrienne.dericco2@upmc.edu
-
Enrolling
Texas
University of Texas Southwestern / Children’s Health, Dallas, TX 75207
Contact
Keianna Brown
Phone: +1 (214) 456-5489
Email: Keianna.brown@utsouthwestern.edu
-
Enrolling
Texas
University of Texas Southwestern, Dallas, TX 75390
Contact
Ashley Keller
Phone: +1 (214) 648-6233
Email: Ashley.Keller@UTSouthwestern.edu
-
Enrolling
Washington
Seattle Children's Hospital, Seattle, WA 98115
Contact
Gracia Bridges
Phone: +1 (206) 987-3921
Email: gracia.bridges@seattlechildrens.org
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
6 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
This study is for people who previously took and then stopped taking or changed how they took elaxacaftor/tezacaftor/ivacaftor, and are now starting vanzacaftor/tezacaftor/deutivacaftor triple combination therapy.
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