Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis (NUC-3)
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ClinicalTrials.gov Identifier: NCT01755507 |
Recruitment Status :
Completed
First Posted : December 24, 2012
Last Update Posted : August 3, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Sclerosing Cholangitis | Drug: norUDCA Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 159 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official 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 |
Study Start Date : | December 2012 |
Actual Primary Completion Date : | October 2015 |
Actual Study Completion Date : | December 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: B
norUDCA
|
Drug: norUDCA
Comparison of different dosages of norUDCA acid administered orally. |
Experimental: C
norUDCA
|
Drug: norUDCA
Comparison of different dosages of norUDCA acid administered orally. |
Placebo Comparator: placebo
Placebo
|
Drug: Placebo |
Experimental: A
norUDCA
|
Drug: norUDCA
Comparison of different dosages of norUDCA acid administered orally. |
- Change in serum AP levels during treatment [ Time Frame: 12 weeks ]
- Proportion of patients with at least 50% reduction in s-ALP [ Time Frame: 12 weeks ]
- Adverse Events [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755507
Austria | |
Prof. M. Trauner | |
Wien, Austria, 1090 | |
Germany | |
Prof. Michael Manns | |
Hannover, Germany, 30623 | |
Norway | |
Kirsten Boberg | |
Oslo, Norway, 0424 |
Principal Investigator: | Michael Trauner, Prof | Med. Uni Wien | |
Principal Investigator: | Michael P Manns, Prof | Med.Hochschule Hannover |
Responsible Party: | Dr. Falk Pharma GmbH |
ClinicalTrials.gov Identifier: | NCT01755507 |
Other Study ID Numbers: |
NUC-3/PSC |
First Posted: | December 24, 2012 Key Record Dates |
Last Update Posted: | August 3, 2016 |
Last Verified: | August 2016 |
PSC |
Cholangitis Cholangitis, Sclerosing Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases |