EUCTR2007-004040-70-AT
Active, not recruiting
Not Applicable
Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients with Primary Biliary Cirrhosis at risk of disease progression
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 183
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed informed consent
- •2\. Age \= 18 years
- •3\. UDCA treatment for at least 6 months prior to inclusion
- •4\. Liver biopsy compatible with PBC
- •5\. Liver biopsy performed within the last 6 months prior to inclusion
- •6\. PBC patients at risk of disease progression based on one or more of the following criteria:
- •\- Serum alkaline phosphatase \= 3 times the upper limit of normal at any time since diagnosis of PBC and ALT \= 2 times upper limit of normal or
- •\- Total Bilirubin \= 1\.0 mg/dl (\= 17 µmol/L) or
- •\- Moderate to severe periportal or periseptal lymphocytic interface hepatitis or\- Periportal and portal fibrosis with numerous septa (Ludwig stage III) without cirrhosis
- •7\. Type 2 anti\-mitochondrial antibodies \> 1:40 by direct immunofluorescence
Exclusion Criteria
- •1\. Histologically proven cirrhosis
- •2\. Positive Hepatitis B or C serology
- •3\. Positive HIV serology
- •4\. Primary Sclerosing Cholangitis
- •5\. Wilson’s\-Disease
- •6\. Celiac Disease (blood tests and/or oesophago\-gastro\-duodenoscopy with histological examination to be performed)
- •7\. a1–anti\-Trypsin\-deficiency
- •8\. Haemochromatosis
- •9\. Autoimmune\-Hepatitis (AIH; defined by an Alvarez score \> 15 without treatment or \= 17 with treatment); Note: PBC/AIH overlap disease, treated insufficiently with UDCA monotherapy may be enrolled
- •10\. Treatment with any of the following drugs within the last 3 months prior to inclusion: colchicine, corticosteroids, azathioprine or other immunosuppressive drugs (e.g. cyclosporine, methotrexate), chlorambucil, D\-penicillamine, fibrates, or antihyperlipidemic drugs
Outcomes
Primary Outcomes
Not specified
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