Assessment of itch symptoms in primary sclerosing cholangitis and other chronic liver diseases

Characterising the burden and clinical trajectory of pruritus in primary sclerosing cholangitis and non-cholestatic chronic liver disease

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15518794

Enrollment

800

Registered

2023-02-20

Start date

2021-10-18

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pruritus in primary sclerosing cholangitis, non-cholestatic chronic liver disease, inflammatory bowel disease Digestive System

Interventions

There will be data collection in the form of health-related questionnaires. These will include questionnaires exploring pruritus and quality of life. Participants' medical record data will also be col

Eligibility

Sex/Gender

All

Age

16 Years to 100 Years

Inclusion criteria

Inclusion criteria: For the PSC group: 1. Must have a diagnosis of PSC 2. Either, subjects attending liver medicine clinic; or registered participants within the nationwide UK-PSC study Non PSC group: 1. Subjects attending the liver or gastroenterology medicine clinic or healthy participants (no present or previous diagnosis of liver disease or IBD) 2. Diagnosis of following liver diseases; metabolic/non-alcoholic fatty liver disease, alcohol induced liver disease, chronic viral hepatitis, drug-induced liver disease, autoimmune hepatitis, genetic disorders of cholestasis 3. Diagnosis of IBD 4. Healthy participants who have no present or previous diagnosis of liver disease or inflammatory bowel disease

Exclusion criteria

Exclusion criteria: PSC group: 1. Age 20 mmol/l Non PSC Group: 1. Age 20 mmol/l 15. Other known dermatological, haematological or extrahepatic disorder, including iatrogenic causes (e.g. excessive opioid use) associated with pruritus; investigator discretion

Design outcomes

Primary

Measure	Time frame
Exploratory primary outcome: The prevalence and long-term variability of pruritus over 48 weeks in patients with primary sclerosing cholangitis. Pruritus is measured using the numerical rating scale (NRS), 5d itch scale and the Simple Cholestatic Complaints Score at baseline, 12, 24, 36 and 48 weeks.	—

Secondary

Measure	Time frame
1. The variability and intensity of pruritus in PSC, compared with pruritus in non-cholestatic liver diseases, IBD alone and healthy participants. Pruritus is measured using the NRS and 5d itch tool at baseline, 12, 24, 36 and 48 weeks for PSC and measured at baseline and 48 weeks for non-cholestatic liver disease, and measured at baseline only for those with IBD alone and healthy participants. 2. Severity and extent of the liver disease, collected from medical records at baseline and up until 48 weeks 3. Routinely collected laboratory blood tests (full blood count, renal function, liver function tests, HbA1C and INR test results) collected during routine clinic visits from baseline up until 48 weeks 4. Exploratory biomarkers (serum bile acid levels and autotaxin activity results) collected during routine clinic visits from baseline and up until 48 weeks 5. Current use of anti-pruritic therapies and their effectiveness, collected from medical records at baseline up until 48 weeks 6. Quality of life measures measured using the Chronic Liver Disease Questionnaire CLDQ and the EQ-5D-5L tools, taken at baseline, 12, 24, 36 and 48 weeks for those with PSC, baseline and 48 weeks for those with non-cholestatic liver disease, and at baseline for those with IBD alone and healthy controls.	—

Measure

Time frame

1. The variability and intensity of pruritus in PSC, compared with pruritus in non-cholestatic liver diseases, IBD alone and healthy participants. Pruritus is measured using the NRS and 5d itch tool at baseline, 12, 24, 36 and 48 weeks for PSC and measured at baseline and 48 weeks for non-cholestatic liver disease, and measured at baseline only for those with IBD alone and healthy participants. 2. Severity and extent of the liver disease, collected from medical records at baseline and up until 48 weeks 3. Routinely collected laboratory blood tests (full blood count, renal function, liver function tests, HbA1C and INR test results) collected during routine clinic visits from baseline up until 48 weeks 4. Exploratory biomarkers (serum bile acid levels and autotaxin activity results) collected during routine clinic visits from baseline and up until 48 weeks 5. Current use of anti-pruritic therapies and their effectiveness, collected from medical records at baseline up until 48 weeks 6. Quality of life measures measured using the Chronic Liver Disease Questionnaire CLDQ and the EQ-5D-5L tools, taken at baseline, 12, 24, 36 and 48 weeks for those with PSC, baseline and 48 weeks for those with non-cholestatic liver disease, and at baseline for those with IBD alone and healthy controls.

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026