EUCTR2016-003367-19-FRActive, not recruitingPhase 1
Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •1. Signed informed consent.
- •2. Males or females.
- •3. Verified PSC.
- •4. Liver biopsy available.
- •5. If pre-treated with ursodeoxycholic acid (UDCA), then stable UDCA dose for = 3 months prior to baseline and must not have exceeded 20 mg/kg/d.
- •6. Alkaline Phosphatase > 1.5 x upper limit of normal (ULN) at baseline.
- •7. PSC patients with or without Inflammatory Bowel Disease (IBD; patients without a definite diagnostic exclusion of IBD need a colonoscopy with segmental biopsy prior to the baseline visit)
- •8. Women of child-bearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile, who are sexually active have to apply a highly effective method of birth control with a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, or sexual abstinence, throughout the treatment period and for four weeks following the last dose of study treatment. Hormonal methods other than levonorgestrel containing devices or medroxyprogesterone injections should be supplemented with use of a male condom. 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 patient has this adequate birth control for study participation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
Exclusion Criteria
- •1. History or presence of other concomitant liver diseases
- •4. Secondary causes of Sclerosing Cholangitis.
- •11. Total bilirubin > 4.0 mg/dl (> 68 µmol/L) at screening or baseline.
- •13. Any known relevant infectious disease (e.g., active tuberculosis, AIDS defining diseases).14. Abnormal renal function.
- •15. Thyroid-stimulating hormone (TSH) > ULN at screening.
- •17. Any active malignant disease.
- •18. Known intolerance/hypersensitivity to study drug, or drugs of similar chemical structure or pharmacological profile.
- •19. Well-founded doubt about the patient’s cooperation.
- •20. Existing or intended pregnancy or breast-feeding.
- •21. Participation in another clinical trial within the last 30 days.
- •22. Patients who have an absolute contraindication for liver biopsy.
Investigators
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