NL-OMON41815Not yet recruitingNot Applicable
Optimizing treatment and follow-up for acute porphyric patients. - Acute Porphyria
Erasmus MC, Universitair Medisch Centrum Rotterdam0 sites1,326 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 1,326
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 12 to 99 (—)
Inclusion Criteria
- •(see Protocol C1. page 14, paragraph 4.2 Inclusion criteria)
- •Acute porphyria patients:
- •- Age 12 years and older
- •- Decreased enzyme activity of porphobilinogen deaminase (acute intermittent porphyria), protoporphyrinogen oxidase (variegate porphyria), and coproporphyrinogen oxidase (hereditary coproporphyria), or an inactivating mutation in the relevant gene or both.
- •- Symptomatic and asymptomatic patients with an identified acute porphyria mutation or biochemical proof of an acute porphyric attack/episode;Healthy controls are unaffected sibs, spouses or friends selected via the cases.;For both groups a signed informed consent form is required.
Exclusion Criteria
- •(see Protocol C1. page 14)
- •Subjects with an increased risk of complication will be excluded from liver biopsy according to guidelines of the American Association for the Study of Liver Diseases, and other risk factors based on local experience.;Contraindications for fine needle biopsy with a 20G needle:;-Under 18 years of age
- •-Uncooperative patient
- •-Unable to give informed consent
- •-Severe coagulopathy
- •-Infection of the hepatic bed
- •-Extra hepatic biliary obstruction
- •-Morbid Obesity
- •-Possible vascular lesions
- •-Amyloidosis
- •-Hydatid disease
- •-Liver fibrosis/ cirrhosis
- •-Pre-existent malignancy in the liver
- •-Any bleeding disorder, including those on aspirin and NSAIDS or any other anticoagulant
Investigators
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