Vitamin B1 as treatment for chronic fatigue in patients with primary biliary cholangitis

Phase 1

• Conditions: Primary biliary cholangitis; MedDRA version: 21.0Level: PTClassification code 10080429Term: Primary biliary cholangitisSystem Organ Class: 10019805 - Hepatobiliary disorders; MedDRA version: 20.1Level: LLTClassification code 10066564Term: Chronic fatigueSystem Organ Class: 100000004867; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2020-004935-26-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-09
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

PBC > 3 months
Chronic fatigue (PBC-40, fatigue score > 32)
Age of 18 years or more
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 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

Comorbidity that can explain fatigue
Non-compliant patients
Pregnancy
Expected surgical intervention during the study period
Chronic kidney disease (GFR<60)

Study & Design

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