Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBC
- Conditions
- Treatment of primary biliary cirrhosisMedDRA version: 9.1Level: LLTClassification code 10036680Term: Primary biliary cirrhosis
- Registration Number
- EUCTR2008-001524-31-NL
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 74
- Signed informed consent
- Male or female patients =18 years of age
- Ursodeoxycholic acid = 10 mg/kg body weight/d treatment for at least 6 months prior to inclusion and responsive (Normalisation of AP or reduction of AP=40 % after onset of UDCA)
- At least 2 out of the following 3 criteria:
• Histologically proven non-cirrhotic liver disease compatible with early-stage PBC (stage I +II)
• Positive AMA (anti-mitochondrial antibody) testing (titer = 1:40)
• Serum alkaline phosphatase > 1.5 times upper limit of normal at any time since diagnosis
- Negative pregnancy test at baseline visit in female patients of childbearing potential
- 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 condom and spermicide), sexual abstinence, partner has undergone vasectomy and subject is in a monogamous relationship. The investigator is responsible for determining whether the subject has adequate birth control for study participation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Histologically proven cirrhosis, PBC stage III + IV - Histology not mandatory
- Positive test for HbsAg and HCV antibodies
- Positive HIV serology
- Features suggestive of other coexistent liver diseases, including hemochromatosis, PSC, alcohol liver disease, Wilsons’s disease, ?-antritrypsin-deficiency
- Hepatic encephalopathy or history of hepatic encephalopathy
- Suspected non-compliance of the patient (suspected difficulties to comply with the study period of 6 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
- Concomitant medication, interacting with Ursofalk® like cholestyramine, colestipol, and aluminium hydroxide
- Acute inflammation of the gall bladder or biliary tract
- Occlusion of the biliary tract (occlusion of the common bile duct or cystic duct)
- Concomitant immunosuppressive therapy (e. g. steroids, azathioprine)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Secondary objectives will be to assess the safety and tolerability in the form of adverse events and laboratory parameters, and to examine patients’ preference of study drug and patients’ quality of life.;Primary end point(s): Relative changes of AP, ?-GT and ALT from the end of the treatment-period with Ursofalk® 250mg capsules to the end of the treatment-period with Ursofalk® 500mg tablets.;Main Objective: The primary objective of this study is to compare the efficacy of Ursofalk® 500 mg tablets [(14±2 mg/kg body weight (BW)/d)] vs. Ursofalk® 250 mg capsules [(14±2 mg/kg body weight (BW)/d)] in the treatment of PBC.
- Secondary Outcome Measures
Name Time Method