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Completed

NCT Number: NCT01755507

Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis

Evaluation of the efficacy of different doses of nor UDCA vs. placebo for the treatment of Primary Sclerosing Cholangitis (PSC). Identification of optimal dose(s)for the treatment of PSC.

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Key information

Conditions

Primary Sclerosing Cholangitis Bile Duct Diseases Biliary Tract Diseases Cholangitis Cholangitis, Sclerosing Digestive System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Prof. M. Trauner, Vienna, Austria

Loading trial locations.

About this study

Double-blind, randomized, multi-center, placebo-controlled, comparative exploratory phase II-finding trial.The study will be conducted with four treatment groups in the form of a parallel-group comparison and will serve to compare oral treatment with either 500 mg/d, 1000 mg/d or 1500 mg/d norursodeoxycholic acid capsules vs. Placebo capsules for the treatment of PSC.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed Informed Consent
  • Verified diagnosis of PSC
  • PSC patients with or without IBD
  • Women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control.

Exclusion criteria

  • History or presence of other concomitant liver diseases
  • Treatment with UDCA within 8 weeks prior to baseline visit.
  • Child B/C liver cirrhosis
  • Total bilirubin > 3.0 mg/dl at screening or baseline.
  • Any relevant systemic disease
  • TSH>ULN at screening
  • any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder
  • Any active malignant disease
  • Known intolerance/hypersensitivity to study drug
  • Existing or intended pregnancy of brest feeding
  • Simultaneous participation in another clinical trial

Treatment and study plan

norUDCA

Drug

Comparison of different dosages of norUDCA acid administered orally.

Placebo

Drug

Primary outcomes

  1. Change in serum AP levels during treatment

    Time frame: 12 weeks

Secondary outcomes

  1. Proportion of patients with at least 50% reduction in s-ALP

    Time frame: 12 weeks

Other outcomes

  1. Adverse Events

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Dr. Falk Pharma GmbH

Industry

Registry information

Official study title

Double-blind,Randomized, Placebo-controlled, Phase II Dose-finding Study Comparing Different Doses of Norursodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing Cholangitis

Acronym: NUC-3

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 24, 2012
Registry last updated
Aug 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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