Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against capsules without active substance), phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo (without active substance) in the treatment of PSC (inflammation of the bile ducts with scar formation)
- Conditions
- primary sclerosing cholangitisMedDRA version: 14.1 Level: LLT Classification code 10036732 Term: Primary sclerosing cholangitis System Organ Class: 10019805 - Hepatobiliary disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2011-002754-31-NO
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 159
1.Signed informed consent,
2.Male or female patients = 18 and < 80 years,
4.Alkaline Phosphatase = 1.5 x ULN at baseline,
6.Women of child-bearing potential have to apply during the entire duration of the study a highly effective method of birth control, which is defined as one which results in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some IUDs. Women of non-childbearing potential may be included if surgically sterile or post-menopausal for at least 2 years. The investigator is responsible for determining whether the subject has this adequate birth control for study participation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1.History or presence of other concomitant liver diseases including:
•Positive hepatitis B or C serology (Hbs Ag+, anti-HBc+, anti-HCV;
Note: Patients who present with anti-HBc+ only, may be included if they are HBV-DNA negative)
•Primary Biliary Cirrhosis, (AMA-positive)
•Wilson’s Disease
•Haemochromatosis
•Autoimmune Hepatitis
•Chronic alcoholic consumption (daily consumption >30g/d)
•Biopsy proven NASH
•Cholangiocarcinoma,
2.Treatment with any of the following drugs within the last 3 months prior to baseline: any glucocorticosteroids (including budesonide), azathioprine or other immunosuppressive drugs (e.g. cyclophosphamide, cyclosporine, methotrexate, tacrolimus, 6-mercaptopurine), chlorambucil, pentoxyfylline, penicillamine, pirfenidone, fibrates, biologics (e.g., anti-tumor necrosis factor-alpha therapy), or rifampicin,
5.Child B/C liver cirrhosis,
12.Total bilirubin > 3.0 mg/dl (> 50 µmol/L), at screening or baseline,
13.Rise in total bilirubin by at least 50% within the last 6 months prior to baseline,
14.Albumin < 36 g/L, at screening or baseline,
16.Any relevant systemic disease (e.g., AIDS),
17.Abnormal renal function (Cystatin C > ULN) at screening and/or at baseline visit,
18.TSH > ULN at screening,
20.Any active malignant disease,
21.Known intolerance/hypersensitivity to study drug, or drugs of similar chemical structure or pharmacological profile
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method