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NCT07255781Visszavonva

Shared Pathways Between Non-Alcoholic Fatty Liver Disease and Psoriatic Disease With Guselekumab Therapy

Shared Mechanisms Contributing to Non-Alcoholic Fatty Liver Disease (NAFLD) and Psoriatic Disease (PD) Severity With Guselkumab Therapy [EMERGE]

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. febr. 23.

Megadott ok: The sponsor determined that enrollment would not meet their expectations and decided to withdraw the study.

Rövid összefoglaló (regiszter, angolul)

The goal of this research study is to better understand if there is an association between non-alcoholic fatty liver disease (NAFLD) and active psoriatic disease (PD), and to assess the effect of Guselkumab (a medication approved by the FDA instead of the standard of care to treat PD), for NAFLD patients who receive Guselkumab for their PD.

Állapot (regiszter)
Visszavonva
Vizsgálattípus
Megfigyeléses
Résztvevők száma
0 (tényleges)
Első benyújtás
2025. szept. 24.
Kezdés
2025. nov. 30.
Elsődleges befejezés
2025. nov. 30.
Fő szponzor
University of California, San Diego
NCT-szám
NCT07255781

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Korábbi kezelés

  • Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy.
  • History of gastrointestinal bypass surgery or ingestion of medications known to produce steatosis, such as corticosteroids, high-dose estrogen, tamoxifen, amiodarone, or tetracycline in the previous 6 months.
  • Evidence of cirrhosis or previously known cirrhosis based on the results from a previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy, or varices

Más betegség

  • Evidence of other causes of chronic liver disease
  • Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg).
  • Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease.
  • Drug-induced liver disease as defined on the basis of typical exposure and history.
  • History of known HIV infection

Laborértékek

  • Previous or current infection with Hepatitis C as defined by presence of hepatitis C virus Ab in serum (anti-HCV Ab).
  • Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis.

Egyéb

  • Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency.
  • Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y/H63D.
  • Bile duct obstruction as shown by imaging studies.
  • Presence of regular and/or excessive use of alcohol (defined as >30g/day for males and >15g/day for females) for a period longer than 2 years at any time in the last 10 years
  • The subject is a pregnant or nursing female

Kiket keres a vizsgálat

  • Adults with a diagnosis of PsA fulfilling the classification for PsA (CASPAR) criteria.
  • Overweight or obese by BMI ≥ 25.0 kg/m2 or ≥ 23.0 for Asian participants
  • Patients are starting Guselkumab therapy as indicated by primary rheumatologist
  • Elevated liver fat on controlled attenuation parameter (CAP) ≥ 288 dB/m, which is consistent with NAFLD after exclusion of secondary causes of liver disease8.

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

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