Primary Sclerosing CholangitisPhase 2NUC-3NCT01755507
Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis
A Phase 2 study testing norUDCA in people with Primary Sclerosing Cholangitis, run by Dr. Falk Pharma GmbH at 3 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Sclerosing Cholangitis
- What is being tested?
- norUDCA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Dec 2012to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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
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.
Read the 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.
- Conditions
- Primary Sclerosing Cholangitis
- Being tested
- norUDCA, Placebo
- Keywords
- PSC
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
norUDCADrug
Comparison of different dosages of norUDCA acid administered orally.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| B | Experimental | norUDCA Receives: Drug: norUDCA |
| C | Experimental | norUDCA Receives: Drug: norUDCA |
| placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| A | Experimental | norUDCA Receives: Drug: norUDCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum AP levels during treatment
Measured: 12 weeks
Secondary outcomes (1)
Proportion of patients with at least 50% reduction in s-ALP
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Sclerosing CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Trauner, Prof, Principal investigator, Med. Uni WienMichael P Manns, Prof, Principal investigator, Med.Hochschule Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755507
- Sponsor's protocol ID
- NUC-3/PSC
- Acronym
- NUC-3
- Status last verified
- Aug 2016
- First submitted
- 19 Dec 2012
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Fickert P, Hirschfield GM, Denk G, Marschall HU, Altorjay I, Farkkila M, Schramm C, Spengler U, Chapman R, Bergquist A, Schrumpf E, Nevens F, Trivedi P, Reiter FP, Tornai I, Halilbasic E, Greinwald R, Prols M, Manns MP, Trauner M; European PSC norUDCA Study Group. norUrsodeoxycholic acid improves cholestasis in primary sclerosing cholangitis. J Hepatol. 2017 Sep;67(3):549-558. doi: 10.1016/j.jhep.2017.05.009. Epub 2017 May 18.
PubMed 28529147
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01755507
- Acronym / sponsor ID
- NUC-3 / NUC-3/PSC
- Conditions
- Primary Sclerosing Cholangitis
- Keywords
- PSC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| B | Experimental | Drug: norUDCAnorUDCA |
| C | Experimental | Drug: norUDCAnorUDCA |
| placebo | Placebo comparator | Drug: PlaceboPlacebo |
| A | Experimental | Drug: norUDCAnorUDCA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| norUDCAComparison of different dosages of norUDCA acid administered orally. | Drug | A, B, C |
| Placebo | Drug | placebo |
Primary outcome
Change in serum AP levels during treatment
Time frame: 12 weeks
1 secondary outcome
Proportion of patients with at least 50% reduction in s-ALP
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Derived from this study: PubMed 28529147Fickert P, Hirschfield GM, Denk G, Marschall HU, Altorjay I, Farkkila M, Schramm C, Spengler U, Chapman R, Bergquist A, Schrumpf E, Nevens F, Trivedi P, Reiter FP, Tornai I, Halilbasic E, Greinwald R, Prols M, Manns MP, Trauner M; European PSC norUDCA Study Group. norUrsodeoxycholic acid improves cholestasis in primary sclerosing cholangitis. J Hepatol. 2017 Sep;67(3):549-558. doi: 10.1016/j.jhep.2017.05.009. Epub 2017 May 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Trauner, Prof principal investigator
Med. Uni Wien
Michael P Manns, Prof principal investigator
Med.Hochschule Hannover
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing norUDCA in people with Primary Sclerosing Cholangitis, run by Dr. Falk Pharma GmbH at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Germany, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum AP levels during treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01755507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.