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NCT07049887 · ClinicalTrials.gov registry record
A Study Describing Scratch and Sleep Patterns in Patients With Primary Biliary Cholangitis (Luminaria)
A clinical trial of Primary Biliary Cholangitis, sponsored by Ipsen.
- Active
- Registry status
- 30
- Enrollment target
- 3
- Study locations
NCT07049887: Active study of Primary Biliary Cholangitis, sponsored by Ipsen.
NCT07049887 is a study of Primary Biliary Cholangitis that is active but no longer recruiting, run by Ipsen. The registered enrollment target is 30 participants, below the 203-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (85% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07049887, a study of Primary Biliary Cholangitis, is active but no longer recruiting, sponsored by Ipsen.
- ACTIVE NOT RECRUITING
- Registry status
- 30 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study will collect information from patients with Primary Biliary Cholangitis (PBC). PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirrhosis). People living with PBC often face challenges like intense itching, trouble sleeping, and feeling constantly tired. These symptoms can make it hard for them to enjoy daily life and feel well overall. While itching and sleep patterns can be difficult to measure accurately based on recall and may lack precision, the main aim of this study is to use a digital health tool to assess the severity of itchiness and sleep patterns in people with PBC. The tool will take the objective measurement for people so they do not have to recall their scratch and sleep patterns. The total study duration for each patient will be about 91 days.
Primary Outcome
Defined as the total number of scratch events detected during sleep periods, monitored using the Nighttime sensor wear. This outcome will be assessed at the end of the wear period.
Conditions Studied
Study Locations (3)
Arizona
- Arizona Liver Center - Chandler
Florida
- University of Miami School of Medicine, Center for Liver Diseases - Miami
Texas
- UT Southwestern Medical Center, Department of Internal Medicine, Digestive and Liver Diseases - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-07-16 |
| Est. Completion | 2026-02-28 |
What the registry record for NCT07049887 still lists
NCT07049887 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 203-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Primary Biliary Cholangitis appearing as the primary indexed condition, and to 0 interventions.
NCT07049887 reports a single indexed study location in Arizona, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT07049887 about?
NCT07049887 is a clinical study titled "A Study Describing Scratch and Sleep Patterns in Patients With Primary Biliary Cholangitis (Luminaria)". This study will collect information from patients with Primary Biliary Cholangitis (PBC). PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirrhosis). People living with PBC often face challenges like in...
What is the current status of trial NCT07049887?
This trial is currently active not recruiting. The enrollment target is 30 participants. The study started on 2025-07-16. Estimated completion is 2026-02-28.
What conditions does trial NCT07049887 study?
This clinical trial studies the following conditions: Primary Biliary Cholangitis.
Who is sponsoring clinical trial NCT07049887?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07049887 being conducted?
This trial has 3 study locations across Arizona, Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Biliary Cholangitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07049887's enrollment target sits among peer trials
30 9th of 8 the lowest of 8 other Primary Biliary Cholangitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Biliary Cholangitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
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