MedTrace Logo

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

NCT02174367 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2017-08-04

No results posted yet for this study

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

DEVICE

Transient elastography

a noninvasive tool for measuring liver stiffness as a predictor of liver fibrosis

Sponsors & Collaborators

Principal Investigators

  • Jonathan N Barker, BSC MD FRCP · King's College London

  • Catherine H Smith, MD FRCP · Guys and St Thomas' Hospitals Foundation Trust and King's College London

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2017-07-31
Completion
2021-07-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02174367 on ClinicalTrials.gov