# Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC)

> **NCT00746486** · PHASE3 · TERMINATED · sponsor: **Dr. Falk Pharma GmbH** · enrollment: 62 (actual)

## Conditions studied

- Primary Biliary Cirrhosis

## Interventions

- **DRUG:** budesonide
- **DRUG:** budesonide placebo

## Key facts

- **NCT ID:** NCT00746486
- **Lead sponsor:** Dr. Falk Pharma GmbH
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2009-02
- **Primary completion:** 2019-10
- **Final completion:** 2019-10
- **Target enrollment:** 62 (ACTUAL)
- **Why stopped:** Study stopped based on the recommendation of the IDMC after a planned Interim Analysis
- **Last updated:** 2020-01-28


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00746486

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00746486, "Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC)". Retrieved via AI Analytics 2026-06-12 from https://api.ai-analytics.org/clinical/NCT00746486. Licensed CC0.

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