19 results
To investigate the origin of BA we will assess which TLR(s) is/are activated. To test the hypothesis that during development of BA and associated liver fibrosis there is a *leaky gut* and/or a change in microbiome we will use human material to…
The primary objective is to minimize fluid reaccumulation in the hepatic cyst after aspiration sclerotherapy in order to reduce cyst size. The secondary objectives are to reduce symptoms, improve health-related quality of life (HRQL), and reduce…
A close correlation has been demonstrated between iron absorption and the capacity of gastric juice to release food iron. At high levels of gastric pH (>3,6), negligible amounts of non-haem iron would be released from dietary components and…
Screening of patients with the inherited liver disease Crigler-Najjar.
The primary objective is to determine the cefazolin penetration into hepatic cysts. Secondary objective are to identify factors affecting antibiotic penetration and to evaluate the association between antibiotic penetration and development of…
To confirm that previous or persisting infection with Chlamydia is associated with the development of perinatal biliary atresia. Furthermore to investigate whether the Chlamydia infection is contracted by vertical transmission from the mothers.
The aim of this study is to investigate the effect of ATP8B1 carrier on hearing in human.
To determine if LA is a familial disease. To identify germline mutations in HNF-1 alpha, ß-catenin and CYP1B1 genes in LA patients. To screen first degree relatives of patients diagnosed with liver adenomatosis for the presence of liver adenomas and…
The aim of this study is to determine whether nose potential difference response is impaired in patients with FIC1-deficiency.
Primary Objective:To demonstrate the efficacy of repeated daily doses of 120 µg/kg/day odevixibat in relieving pruritus in patients with ALGS.Secondary Objectives:To assess the impact of odevixibat on serum bile acid levels in patients with ALGS.To…
This study has been transitioned to CTIS with ID 2023-506637-30-00 check the CTIS register for the current data. The main objective of this study is to determine whether lowering estrogen and progesterone levels with leuprorelin decreases liver…
Primary Objective (Cohort 1)To demonstrate a sustained effect of A4250 on serum bile acids and pruritus in children with progressive familial intrahepatic cholestasis (PFIC) Types 1 and 2.Primary Objective (Cohort 2)To evaluate the effect of A4250…
This study has been transitioned to CTIS with ID 2024-512086-14-00 check the CTIS register for the current data. Primary Objective:The primary objective is to evaluate the efficacy of repeated once-daily doses of odevixibat versus placebo in…
This study has been transitioned to CTIS with ID 2023-509028-17-00 check the CTIS register for the current data. To demonstrate a sustained effect of odevixibat on pruritus in patients with ALGS who have completed study A4250-012 (ASSERT)
Primary Objectives• Safety and tolerability• PK of OCA and its conjugates o SD PK Phase: To assess the PK of OCA and its conjugates after a single low dose of OCA on Day 1 and determine subject eligibility for the MD Phase o MD Phase: To assess the…
The main objective is to compare laparoscopic fenestration and aspiration sclerotherapy in patients with large symptomatic hepatic cysts on patient-reported outcomes. This information can be used to assess cost-effectiveness in both treatments.
To demonstrate the efficacy of repeated daily doses of 40 µg/kg/day and 120 µg/kg/day A4250 in children with progressive familial intrahepatic cholestasis (PFIC) Types 1 and 2, as determined by the following:* Proportion of patients experiencing at…
The identification of a new gene(s) that causes autosomal dominant polycystic liver disease.
The primary objective is to evaluate the effect of UDCA and ezetimibe on cholesterol elimination assessed as total faecal sterol concentration. Secondary objective is to assess the effect of UDCA and ezetimibe on plasma lipid profile/composition.