An exploratory Phase II Study to demonstrate the Safety and Efficacy of A4250 in Patients with Cholestatic Pruritus

Phase 1

• Conditions: Patients wih Cholestatic Pruritus; MedDRA version: 19.0Level: PTClassification code 10064190Term: Cholestatic pruritusSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-001157-32-DK
• Lead Sponsor: Albireo AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-30
• Last Update Posted: 5 June 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

•Diagnosis of pruritus due to chronic cholestasis based on history and investigator judgment
- This will include but will not be restricted to patients with Progressive familial intrahepatic cholestasis (PFIC), Alagille syndrome (ALGS), Biliary Atresia and Sclerosing Cholangitis
•Laboratory markers of cholestasis identified within 3 months before Visit 1

Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Any condition that in the opinion of the investigator constitutes a risk for the patient or a contraindication for participation and completion of the study, or could interfere with study objectives, conduct, or evaluations
•Clinical or biochemical signs of decompensated liver disease
•Liver transplantation
•Other reason for pruritus than chronic cholestasis such as treatment refractory atopic dermatitis, other primary skin diseases etc.
•Treatment with bile acid sequestrants (cholestyramine, colesevelam, colestipol or similar) during the screening period

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified