Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Primary Sclerosing Cholangitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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B

norUDCA

Group Type EXPERIMENTAL

norUDCA

Intervention Type DRUG

Comparison of different dosages of norUDCA acid administered orally.

C

norUDCA

Group Type EXPERIMENTAL

norUDCA

Intervention Type DRUG

Comparison of different dosages of norUDCA acid administered orally.

placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

A

norUDCA

Group Type EXPERIMENTAL

norUDCA

Intervention Type DRUG

Comparison of different dosages of norUDCA acid administered orally.

Interventions

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norUDCA

Comparison of different dosages of norUDCA acid administered orally.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No