NCT02174367

An Observational Cohort Study Evaluating Fatty Liver Disease and Liver Fibrosis in Moderate to Severe Psoriasis

An Observational Cohort Study to Evaluate Factors Affecting Prevalence of Fatty Liver Disease and Fibrosis and Factors Affecting Response to Treatment in Patients With Psoriasis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

• Main objectives and outcome measures. 1. Establish prevalence of and factors contributing to fatty liver disease and liver fibrosis in patients with psoriasis. Fatty liver disease diagnosed via ultrasound. Liver fibrosis diagnosed by liver biopsy or non-invasive tests of fibrosis including transient elastography, ultrasound, serum markers of fibrosis including procollagen-3-N-terminal peptide (P3NP). 2. Evaluate non-invasive markers of liver fibrosis in the psoriasis population. Namely transient elastography, standard liver function tests and P3NP. 3. Evaluate the impact of psoriasis disease severity and comorbidities including metabolic syndrome on response to treatment in patients with psoriasis. Data on co-morbid disease collected through questionnaires and review of medical records. Response to treatment assessed using psoriasis area and severity index (PASI) physician global assessment (PGA) and dermatology life quality index (DLQI). * Study population: 380 patients with moderate to severe psoriasis will be prospectively recruited to the study. * Chief investigator: Professor Jonathan Barker. Co-investigator: Professor Catherine Smith * Sponsor/funding organization: Pfizer and Biomedical Research Centre (BRC) at Guys and St Thomas Hospitals Trust

Conditions

• Psoriasis Chronic
• Liver Fibrosis
• Fatty Liver
• Non-alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DEVICE	Transient elastography	a noninvasive tool for measuring liver stiffness as a predictor of liver fibrosis

Timeline

• Start date: 2012-11-01
• Primary completion: 2017-07-01
• Completion: 2021-07-01
• First posted: 2014-06-25
• Last updated: 2017-08-04

Locations

1 site across 1 country: United Kingdom