norUrsodeoxycholic Acid vs Placebo in PSC

Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing norUrsodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing Cholangitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03872921

Enrollment

303

Registered

2019-03-13

Start date

2018-02-08

Completion date

2026-06-30

Last updated

2024-08-06

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

Conditions

Primary Sclerosing Cholangitis

Brief summary

Double-blind, randomized, multi-center, placebo-controlled, comparative, phase III trial. The study will be conducted with two treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d norursodeoxycholic acid capsules or placebo capsules for the treatment of Primary Sclerosing Cholangitis.

Interventions

DRUGnorUrsodeoxycholic Acid

oral treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Signed informed consent * verified PSC * Liver Biopsy available for Review * If pre-treated with UDCA Patient must be on stable dose not exceeding 20mg/kg/bw * Patients with or without concomittant IBD

Exclusion criteria

* History or presence of other concomitant liver diseases * Presence of Cholangiocarcinoma * Secondary causes of Sclerosing Cholangitis * Small Duct Cholangitis in the absence of large duct disease * Any known relevant infectious disease * Abnormal renal function * Any active malignant disease * Known intolerance/hypersensitivity to study drug

Design outcomes

Primary

Measure	Time frame	Description
superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC)	2 years	prevention of disease progression assessed by partial normalization of serum Alkaline Phosphatase (s-ALP) levels in patients with PSC
Show superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC)	2 years	prevention of disease progression assessed by liver histology

Countries

Austria, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026