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Clinical Trials/NCT07022327
NCT07022327Active, not recruitingNot Applicable

IMPACT Study: Intervention Monitoring for Pancreatitis in an Adolescent Undergoing Clinical Treatment

Mission: Cure1 site in 1 country1 target enrollmentStarted: May 6, 2025Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
1
Locations
1
Primary Endpoint
Time Between Acute Pancreatitis Episodes While on Ivacaftor

Study Overview

Brief 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).

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • The subject has been diagnosed with recurrent acute pancreatitis or chronic pancreatitis and a clinical decision has been made to treat the subject with one or more FDA-approved therapies, which may be being used off-label) to treat or prevent pancreatitis symptoms.

Exclusion Criteria

  • Participant has a known cystic fibrosis-associated CFTR mutation that would qualify them for standard Ivacaftor use.
  • Participant is unable to tolerate Ivacaftor due to prior adverse reactions.
  • Participant has severe liver dysfunction or baseline liver enzyme elevations that contraindicate Ivacaftor use, as determined by the treating physician.
  • Participant or parent/guardian is unwilling to comply with study procedures, including regular follow-up and data sharing.
  • Any other medical or psychological condition, in the judgment of the treating physician or counselor, that would make participation unsafe or not in the best interest of the participant.

Outcomes

Primary Outcomes

Time Between Acute Pancreatitis Episodes While on Ivacaftor

Time Frame: 12 months

The number of days between clinically confirmed acute pancreatitis attacks during the 12-month Ivacaftor treatment period, compared to historical pre-treatment intervals.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Mission: Cure
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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