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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Pruritus in primary sclerosing cholangitis, non-cholestatic chronic liver disease, inflammatory bowel disease
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Primary sclerosing cholangitis (PSC) is a disease that causes inflammation and scarring of the bile ducts. There are no medicines that have been shown to slow down the rate of liver damage, and liver transplantation is the only life-saving treatment for people with the disease.
Whilst many clinical trials are underway, few address the symptoms of the disease. In a survey led by the international charity PSC Support, itching (pruritus) was named as one of the symptoms that impacted quality of life the most. However, there is no published study so far which indicates how this symptom varies according to the natural history of the disease, or according to currently available anti-itch medicines.
The aim of this study is to obtain detailed information on the presence and impact of itch symptoms in people who have the liver condition primary sclerosing cholangitis and compare this with itch symptoms in other chronic liver diseases, in those with inflammatory bowel disease (IBD) alone and in healthy participants. The researchers will investigate if there are any links between itch symptoms and the severity of the liver disease and blood test results. The variability of itch symptoms over a 48-week period will also be observed, along with the impact itch has on quality of life.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
PSC group:1. Age <16 years2. Women who are pregnant or lactating3. Lack of capacity (as deemed by the investigator) to provide an accurate medical history4. Not able to communicate in English and no translator available5. Small duct PSC without concomitant inflammatory bowel disease (IBD)6. Other causes of chronic liver disease including 6.1. IgG4-related disease6.2. Primary biliary cholangitis (PBC)6.3. Secondary sclerosing cholangitis6.4. Fatty liver disease6.5. Habitual alcohol consumption greater than 21 oz/week for men or 14 ox/week for women6.6. HIV infection6.7. Drug-induced liver disease6.8. Genetic disorders of cholestasis6.9. Wilson disease6.10. Alpha-1-antitrypsin deficiency6.11. Hepatic veno-occlusive disease, including portal vein thrombosis or Budd-Chiari syndrome7. History of liver transplantation8. Current or prior history of cholangiocarcinoma, pancreatic or hepatocellular cancer9. Gallbladder cancer in the previous 12 months10. Colorectal cancer (or evidence of active metastatic disease) in the previous twelve months11. Chemo- or radiotherapy in the previous twelve months12. Chronic kidney disease, defined by the use of renal replacement therapy or a urea >20 mmol/l
Non PSC Group:1. Age <16 years2. Women who are pregnant or lactating3. Lack of capacity (as deemed by the investigator) to provide an accurate medical history4. Not able to communicate in English and no translator available5. Radiological evidence of cholangiography including secondary sclerosing cholangitis6. Histological evidence of inflammatory bile duct lesions or periductal fibrosis7. Mixed aetiology of liver disease8. Other causes of chronic liver disease:8.1. Primary biliary cholangitis (PBC)8.2. Primary sclerosing cholangitis (PSC)8.3. HIV infection8.4. Wilson disease8.5. Alpha-1-antitrypsin deficiency8.6. Hepatic veno-occlusive disease, including portal vein thrombosis or Budd-Chiari syndrome9. History of liver transplantation10. Current or prior history of cholangiocarcinoma, pancreatic or hepatocellular cancer11. Gallbladder cancer in the previous 12 months12. Colorectal cancer (or evidence of active metastatic disease) in the previous twelve months13. Chemo- or radiotherapy in the previous twelve months14. Chronic kidney disease, defined by the use of renal replacement therapy or a urea >20 mmol/l15. Other known dermatological, haematological or extrahepatic disorder, including iatrogenic causes (e.g. excessive opioid use) associated with pruritus; investigator discretion
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Nasir
Hussain
+44 (0)7877427846
nxh100@student.bham.ac.uk
The study is sponsored by University of Birmingham and funded by GlaxoSmithKline.
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