Clinical Trial

Ivacaftor Impact in an Adolescent Without a Cystic Fibrosis-Associated CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Mutation for Chronic Pancreatitis: Single-Patient Study Tracking Flare Frequency and Health Data Compared to Historical Records.

Study acronym: IMPACT
Active, Not Recruiting
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Record status
This record was last updated June 15, 2025 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this observational study is to learn about the long-term effects of Ivacaftor in an adolescent without a cystic fibrosis-associated CFTR mutation who is taking Ivacaftor to treat chronic pancreatitis. The main question it aims to answer is: Does Ivacaftor reduce the frequency or severity of acute pancreatitis episodes in this adolescent compared to their historical medical data? The participant, who is already taking Ivacaftor as part of their medical care, will be monitored over the course of 12 months. Flare frequency, hospitalizations, and wellness data will be tracked through caregiver reports, lab data, and physiological data collected from a wearable health monitoring device (Apple Watch).
Trial Details
NCT Number NCT07022327
Lead Sponsor Mission: Cure
Conditions Chronic Pancreatitis
Enrollment 1 participants
Start Date 2025-05-06
Primary Completion 2026-05 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2025-06-15