NL-OMON50822RecruitingNot Applicable
Oxylipins and lipoxygenases in cholestatic itch - OaLiCI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 220
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 12 to 99 (—)
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject should:
- •1. Be able to provide informed consent
- •2. Meet the criteria of one of the following subgroups:
- •a) Patients of >=18 years of age who are diagnosed with non-hereditary
- •hepatobiliary diseases leading to cholestasis e.g.:
- •Primary sclerosing cholangitis (PSC)
- •Based on: elevated serum alkaline phosphatase and *GT and characteristic
- •lesions on ERCP and/or magnetic resonance cholangiopancreaticography (MRCP)
- •Primary biliary cholangitis (PBC)
- •Based on >=2 of 3 criteria: history of elevated alkaline phosphatase for at
- •least 6 months, liver biopsy consistent with PBC, positive anti-mitochondrial
- •antibody titer (or when low in titer anti-GP210 and/or anti-SP100 and/or
- •anti-PDC-E2 antibodies)
- •Malignant cholestatic diseases (e.g. cholangiocarcinoma)
- •Based on the criteria of the subdiagnosis.
- •b) Patients prone to hereditary cholestatic diseases (patients of < 18 years of
- •age are exempted from punch biopsies):
- •Progressive familial intrahepatic cholestasis (PFIC)
- •Based on: confirmed mutations in the ATP8B1, ABCB11 or ABCB4 genes.
- •Alagille syndrome
- •Based on: confirmed mutations in the JAG1 or NOTCH2 genes.
- •c) Patients of >=18 years of age who are prone to intrahepatic cholestasis of
- •pregnancy (ICP).
- •Based on: pruritus in pregnancy, elevated serum ALT activities and fasting
- •bile acid levels, and exclusion of other causes of liver dysfunction or
- •itching. Serum liver tests and fasted bile acids should normalize after
Exclusion Criteria
- •Subjects who could be considered as a vulnerable population will be excluded
- •from participation in this study:
- •1. Clinically unstable subjects (as assessed by their treating physician)
- •2. Subjects with a confirmed infection
- •3. Subjects with a dermatologic disease other than the skin phenotype
- •associated with cholestasis
- •4. Subjects admitted to the ICU
- •5. Subjects experiencing itch as a result of cholestasis for less than three
- •6. Subject who are prone to another hepatic disease
Investigators
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