Restarting Triple Therapy With Robust Monitoring for Adverse Events (RETRIAL)

Enrolling by invitationOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

March 31, 2028

Study Completion Date

June 30, 2028

Conditions
Cystic Fibrosis
Interventions
OTHER

RETRIAL-MH

Participants will complete: daily diaries for 6 weeks, from about 2 weeks prior to starting VTD to about 4 weeks after; biweekly surveys, from about 2 weeks prior to starting VTD to 6 months after, and 2 quarterly surveys (at 9mo and 12mo post-initiation of VTD).

OTHER

RETRIAL-Liver

Participants may have a research liver function test done prior to starting VTD and 28 days after, if not done clinically.

OTHER

RETRIAL-Neuro

participants will complete a neurocognitive assessment prior to starting VTD and 28 days after.

Trial Locations (17)

15224

University of Pittsburgh Medical Center, Pittsburgh

19803

Nemours Children's, Wilmington

21287

Johns Hopkins University, Baltimore

30322

Emory University, Atlanta

32207

Nemours Children's, Jacksonville

32514

Nemours Children's, Pensacola

32827

Nemours Children's, Orlando

47405

Indiana University, Bloomington

48109

University of Michigan, Ann Arbor

63130

Washington University at St. Louis, St Louis

66160

Kansas University Medical Center, Kansas City

75235

University of Texas Southwestern Medical Center, Dallas

80045

Children's Hospital Colorado, Aurora

80206

National Jewish Health, Denver

98105

Seattle Children's Hospital, Seattle

02114

Massachusetts General Hospital, Boston

02215

Boston Children's Hospital, Boston

All Listed Sponsors
collaborator

Cystic Fibrosis Foundation

OTHER

collaborator

Johns Hopkins University

OTHER

collaborator

Massachusetts General Hospital

OTHER

collaborator

National Jewish Health

OTHER

collaborator

Indiana University

OTHER

collaborator

Children's Hospital Colorado

OTHER

collaborator

University of Kansas Medical Center

OTHER

collaborator

Washington University School of Medicine

OTHER

lead

Boston Children's Hospital

OTHER