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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 August 2016 |
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Main ID: |
NCT01755507 |
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Date of registration:
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19/12/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis
NUC-3 |
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Scientific title:
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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 |
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Date of first enrolment:
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December 2012 |
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Target sample size:
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159 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01755507 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Austria
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Germany
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Norway
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Contacts
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Name:
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Michael P Manns, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Med. Hochschule Hannover |
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Name:
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Michael Trauner, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Med. Uni Wien |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Primary Sclerosing Cholangitis
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Intervention(s)
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Drug: Placebo
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Drug: norUDCA
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Primary Outcome(s)
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Change in serum AP levels during treatment
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Proportion of patients with at least 50% reduction in s-ALP
[Time Frame: 12 weeks]
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Secondary ID(s)
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NUC-3/PSC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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