Last updated: 05/19/2025 08:40:12
A Study on Cholestatic Pruritus Treatment Associated with Primary biliary cholangitis (PBC)
GSK study ID
218409
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: Prospective Observational Study of Real-World Clinical Practice of Cholestatic Pruritus Treatment Associated with PBC (CHAPTER)
Trial description: This is an observational, longitudinal, non-interventional study of adult Primary biliary cholangitis (PBC) participants with pruritus. This study includes a mix of validated and original measures designed to assess several facets of pruritus over time. The validated measures include disease and symptom specific measures of pruritus severity and impact.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of Participants with each Initial Treatment Choice
Timeframe: Up to 9 months post enrolment
Number of Participants with Different levels of Treatment Satisfaction
Timeframe: Up to 9 months post enrolment
Number of Participants with different levels of Adherence to Treatment
Timeframe: Up to 9 months post enrolment
Mean duration of initial pruritus treatment
Timeframe: Up to 9 months post enrolment
Number of Participants with Changes to Pruritus Treatment Regimen, Including Discontinuation, Switches to or Initiation of New Treatments
Timeframe: Up to 9 months post enrolment
Factors Driving the Changes in Pruritus Treatment Regimen
Timeframe: Up to 9 months post enrolment
Itch Characteristics Including, Presence, Severity, Location, and Timing of Pruritus Over Time
Timeframe: Up to 9 months post enrolment
Change in Patient-reported outcome (PRO) Scores measuring Health-Related Quality of Life, Including Sleep and Wellbeing
Timeframe: Up to 9 months post enrolment
Secondary outcomes:
Healthcare Resource Utilization of Participants with Primary biliary cholangitis (PBC) and Pruritus Initiating Treatment for Pruritus
Timeframe: Up to 9 months post dose
Interventions:
Not applicable
Enrollment:
200
Primary completion date:
2024-26-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cholestasis
Product
Not applicable
Collaborators
Not applicable
Study date(s)
December 2023 to July 2024
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Participant must be currently living in the United States (US) or Germany
- Participant must be able to read and respond to questions in the study language (US English or German)
- Participants participating in ongoing, interventional clinical trials for PBC and/or pruritus treatments at the time of screening
Inclusion and exclusion criteria
Inclusion criteria:
- Participant must be currently living in the United States (US) or Germany
- Participant must be able to read and respond to questions in the study language (US English or German)
- Participant must have a confirmed diagnosis of Primary biliary cholangitis (PBC) a. Diagnosis will be confirmed by site or clinician during screening
- Participant must be either a. Starting their first prescription treatment for cholestatic pruritus or has started such a treatment within the past 6 months, or b. Diagnosed with PBC within the past 6 months and currently experiencing mild to severe cholestatic pruritus, but has not initiated a prescription treatment for cholestatic pruritus within the past 6 months
Exclusion criteria:
- Participants participating in ongoing, interventional clinical trials for PBC and/or pruritus treatments at the time of screening
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Other
Actual primary completion date
2024-26-07
Actual study completion date
2024-26-07
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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