An Observational Cohort Study Evaluating Fatty Liver Disease and Liver Fibrosis in Moderate to Severe Psoriasis
NCT02174367
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Patients who have given written informed consent
- Psoriasis patients - chronic plaque-type psoriasis; PASI of 10 or above currently or in past.
- 18 yrs. of age
- Patients who have not given written informed consent
- Patients under 18 yrs. of age
- Patients with a PASI less than 10.
- Pregnant women
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Descriptive Information | |||||||
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Brief Title | An Observational Cohort Study Evaluating Fatty Liver Disease and Liver Fibrosis in Moderate to Severe Psoriasis | ||||||
Official Title | 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 | ||||||
Brief Summary | ? Main objectives and outcome measures.
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).
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Detailed Description | Not Provided | ||||||
Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||||
Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Retention: Samples With DNA Description: Serum stored for analysis of non-invasive markers of fibrosis and DNA analysis | ||||||
Sampling Method | Probability Sample | ||||||
Study Population | Hospital outpatient clinic | ||||||
Condition |
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Intervention | Device: Transient elastography
a noninvasive tool for measuring liver stiffness as a predictor of liver fibrosis Other Name: Fibroscan | ||||||
Study Groups/Cohorts | Psoriasis
Patients with moderate to sever psoriasis attending a tertiary referral center. patients will be evaluated with a questionnaire, measurement of height,weight, waist circumference, fasting bloods, abdominal ultrasound and transient elastography. Intervention: Device: Transient elastography | ||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status | Active, not recruiting | ||||||
Actual Enrollment | 400 | ||||||
Original Estimated Enrollment | 380 | ||||||
Estimated Study Completion Date | July 2021 | ||||||
Actual Primary Completion Date | July 2017 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 100 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | United Kingdom | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT02174367 | ||||||
Other Study ID Numbers | WS1851782 11/LO/1236 ( Other Identifier: London REC reference number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | King's College London | ||||||
Study Sponsor | King's College London | ||||||
Collaborators | Pfizer | ||||||
Investigators |
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PRS Account | King's College London | ||||||
Verification Date | June 2017 |