Status:
TERMINATED
Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC)
Lead Sponsor:
Dr. Falk Pharma GmbH
Conditions:
Primary Biliary Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study is aimed to compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight (BW)/d) plus budesonide (9 mg/d) vs. ursodeoxycholic acid (12-16...
Eligibility Criteria
Inclusion
- Signed informed consent
- Age ≥ 18 years
- UDCA treatment for at least 6 months prior to inclusion
- Liver biopsy compatible with PBC
- Liver biopsy performed within the last 6 months prior to inclusion
- 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
- Type 2 anti-mitochondrial antibodies \> 1:40 by direct immunofluorescence
- Women of child-bearing potential have to apply appropriate contraceptive methods, e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a condom and spermicide), partner has undergone vasectomy and subject is in monogamous relationship. The investigator is responsible for determining whether the subject has adequate birth control for study participation
Exclusion
- Histologically proven cirrhosis
- Positive Hepatitis B or C serology
- Positive HIV serology
- Primary Sclerosing Cholangitis
- Wilson's-Disease
- Celiac Disease (blood tests and/or oesophago-gastro-duodenoscopy with histological examination to be performed)
- α1-anti-Trypsin-deficiency
- Haemochromatosis
- 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
- 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
- Treatment with ketoconazole or other CYP3A inhibitors within the last 4 weeks before baseline; rifampicin (up to 600 mg/d) is allowed to treat pruritus until baseline
- Sonographic or endoscopic signs of portal hypertension
- Ascites or history of ascites
- Hepatic encephalopathy or history of hepatic encephalopathy
- Total bilirubin \> 3.0 mg/dl (\> 50 µmol/L)
- Albumin \< 36 g/L
- Prothrombin ratio \< 70%
- Platelet count \< 135.000/mm3
- Osteoporosis proven by bone densitometry
- Diabetes mellitus, defined as B-Glucose \> 125 mg/dl on an empty stomach (even when controlled)
- Hypertension, defined as persistent raised blood pressure \> 140/90 mmHg
- Suspected non-compliance of the patient (suspected difficulties to comply with the study period of 36 months)
- Severe co-morbidity substantially reducing life expectancy
- Known intolerance/hypersensitivity/resistance to study drugs or drugs of similar chemical structure or pharmacological profile
- Existing or intended pregnancy or breast-feeding
- Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00746486
Start Date
February 1 2009
End Date
October 1 2019
Last Update
January 28 2020
Active Locations (2)
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1
Hôpital Saint-Antoine
Paris, France, 75571
2
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany, 53105