Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis (NUC-3)
This study has been completed.
Sponsor:
Dr. Falk Pharma GmbH
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01755507
First received: December 19, 2012
Last updated: August 2, 2016
Last verified: August 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Sclerosing Cholangitis |
Drug: norUDCA Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Dr. Falk Pharma GmbH:
Primary Outcome Measures:
- Change in serum AP levels during treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of patients with at least 50% reduction in s-ALP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Other Outcome Measures:
- Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 159 |
| Study Start Date: | December 2012 |
| Study Completion Date: | December 2015 |
| Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01755507
Please refer to this study by its ClinicalTrials.gov identifier: NCT01755507
Locations
| Austria | |
| Prof. M. Trauner | |
| Wien, Austria, 1090 | |
| Germany | |
| Prof. Michael Manns | |
| Hannover, Germany, 30623 | |
| Norway | |
| Kirsten Boberg | |
| Oslo, Norway, 0424 | |
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
| Principal Investigator: | Michael Trauner, Prof | Med. Uni Wien |
| Principal Investigator: | Michael P Manns, Prof | Med. Hochschule Hannover |
More Information
| Responsible Party: | Dr. Falk Pharma GmbH |
| ClinicalTrials.gov Identifier: | NCT01755507 History of Changes |
| Other Study ID Numbers: | NUC-3/PSC |
| Study First Received: | December 19, 2012 |
| Last Updated: | August 2, 2016 |
| Health Authority: | Austria: Austrian Medicines and Medical Devices Agency Germany: Federal Institute for Drugs and Medical Devices Norway: Norwegian Medicines Agency |
Keywords provided by Dr. Falk Pharma GmbH:
|
PSC |
Additional relevant MeSH terms:
|
Cholangitis Cholangitis, Sclerosing Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on September 26, 2016