Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis

Dr. Falk Pharma GmbH65 enrolled

Overview

The purpose of this study is to compare the efficacy of Ursofalk 500 mg tablets versus Ursofalk 500 mg capsules in the treatment of Primary Biliary Cirrhosis (PBC).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Primary Biliary Cirrhosis

Interventions

UDCA (Ursodeoxycholic acid)DRUG

250 mg

UDCA (Ursodeoxycholic acid)DRUG

500 mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Negative pregnancy * Signed informed consent * Histologically proven non-cirrhotic liver disease Exclusion Criteria: * histologically proven cirrhosis * PBC stage II+IV * Positive HIV serology

Locations (1)

Klinikum Grosshadern

Munich, Germany

Outcomes

Primary Outcomes

Change of liver enzymes between baseline and the end of the treatment-period with Ursofalk 250 mg capsules and the end of treatment-period with Ursofalk 500 mg tablets.

Time frame: Between baseline and week 24

Secondary Outcomes

Quality of Life

Time frame: Between baseline and week 24

Data from ClinicalTrials.gov

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