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Effect of bile drainage and rifampicin, a pregnane X receptor agonist, on clinical and biochemical recovery of patients with obstructive cholestasis

Effect of bile drainage and rifampicin, a pregnane X receptor agonist, on clinical and biochemical recovery of patients with obstructive cholestasis - BIDRIP trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36732
Enrollment
55
Registered
2011-12-06
Start date
2012-10-25
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obstructive cholestasis

Interventions

Rifampicin 150 mg twice a day for seven days and blood samples (3x 15 ml)

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Male or female with severe obstructive cholestasis for whom biliary drainage by PTC or nasobiliary drainage by ERCP is clinically indicated. - An established diagnosis of obstructive cholestasis by ultrasound-scan (US-scan), magnetic resonance cholangiopancreatography (MRCP) and/or endoscopic retrograde cholangiopancreatography (ERCP). - Age 18-90 years - Able to understand and give fully informed written consent - Hyperbilirubinemia > 170 umol/L - Cholestatic serum enzyme pattern

Exclusion criteria

Exclusion criteria: - Patients with purely hepatocellular, non-obstructive cholestasis in whom biliary drainage by PTC or ERCP is not clinically indicated - Patients with known allergy to rifampicin

Design outcomes

Primary

MeasureTime frame
Serum bilirubin levels

Secondary

MeasureTime frame
• Quality of life (QoL; SF-36) and itch intensity (VAS), • Serum: bilesalt profil, lysofosfaticid acid, autotaxine, fribroblast growth factor 19, Asat, Alat, alkaline phosphatase and gamma-glutamyltransferase • Bile: lysofosfaticid acid, autotaxine, fribroblast growth factor 19 and bicarbonate

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)