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

Phase 2

Completed

Conditions: Primary Sclerosing Cholangitis
bile ducts inflammation with scar formation
10017969

Registration Number: NL-OMON39746

Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

1. Signed informed consent,;2. Male or female patients * 18 and < 80 years,;3. PSC verified by 2 of the following criteria:
* Chronische cholestatic diesease of at least 6 month duration
* Retrograde, operative, percutaneous, or magnestic resonance cholangiography *
* Liver biopsy available for review and compatible with the diagnosis of PSC;
4. Alkaline Phosphatase * 1,5 x ULN at baseline
5. PSC Patients with or without IBD
6. Women of child-bearing 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 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 (> 51,3µmol/L), at screening or baseline,;13. Both total bilirubin levels > ULN within the last 6 months prior to baseline and a rise of this level by more than 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 >1.15 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Mean relative change (%) of serum alkaline phosphatase (sALP) between baselien<br /><br>visit and EOT visit (last observation carried forward).</p><br>

Secondary Outcome Measures