Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01755507

Acronym

NUC-3

Enrollment

159

Registered

2012-12-24

Start date

2012-12-31

Completion date

2015-12-31

Last updated

2016-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sclerosing Cholangitis

Keywords

PSC

Brief summary

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.

Detailed description

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.

Interventions

DRUGnorUDCA

Comparison of different dosages of norUDCA acid administered orally.

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Signed Informed Consent 2. Verified diagnosis of PSC 3. PSC patients with or without IBD 4. Women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control.

Exclusion criteria

1. History or presence of other concomitant liver diseases 2. Treatment with UDCA within 8 weeks prior to baseline visit. 3. Child B/C liver cirrhosis 4. Total bilirubin \> 3.0 mg/dl at screening or baseline. 5. Any relevant systemic disease 6. TSH\>ULN at screening 7. any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder 8. Any active malignant disease 9. Known intolerance/hypersensitivity to study drug 10. Existing or intended pregnancy of brest feeding 11. Simultaneous participation in another clinical trial

Design outcomes

Primary

Measure	Time frame
Change in serum AP levels during treatment	12 weeks

Secondary

Measure	Time frame
Proportion of patients with at least 50% reduction in s-ALP	12 weeks

Other

Measure	Time frame
Adverse Events	12 weeks

Countries

Austria, Germany, Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026