Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose

Summary

Rationale: Hepatic encephalopathy (HE) is a major and common complication in patients with liver cirrhosis. HE can be classified in the extensive range of neurocognitive deterioration as minimal HE (MHE), covert HE (grade I), or overt HE (OHE, grade II-IV). Liver cirrhosis is the most common cause of portal hypertension (PH). Patients who develop complications of PH, like variceal bleeding or refractory ascites, can benefit from a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement. Unfortunately, post-TIPS HE is a common and often severe complication. Incidence of new onset or worsening of HE after TIPS is approximately 20-45%. Currently there is no strategy to prevent post-TIPS HE.

Conditions

• Hepatic Encephalopathy
• Cirrhosis, Liver
• Portal Hypertension
• Liver Diseases
• Pathological Processes

Interventions

DRUG

Rifaximin 550 milligram Oral Tablet [XIFAXAN]

Rifaximin 550 milligram b.i.d. 72 hours before TIPS placement till 3 months post-TIPS

DRUG

Placebo oral tablet

Placebo b.i.d. 72 hours before TIPS placement till 3 months post-TIPS

DRUG

Lactulose 667 milligram/milliliter Oral Solution

Lactulose based on soft stool frequency, 72 hours before TIPS placement till 3 months post-TIPS

Sponsors & Collaborators

• Erasmus Medical Center

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• Norgine

  collaborator INDUSTRY

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  lead OTHER

Principal Investigators

• Bart Takkenberg, MD, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-21

Primary Completion

2026-09-30

Completion

2026-12-31

Countries

• Belgium
• Netherlands

Study Locations