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Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS (PRPET)

T

Toulouse University Hospital

Status and phase

Completed
Phase 3

Conditions

Cirrhosis

Treatments

Drug: Rifaximin
Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02016196
RC31/12/0551

Details and patient eligibility

About

TIPS has been used for 20 years, as a means of reducing portal pressure in patients with cirrhosis and portal hypertension related complications. TIPS proved more effective than alternative treatments in controlling or preventing variceal bleeding and refractory ascites. The main drawback of the TIPS procedure is progressive overt hepatic encephalopathy (OHE). Three risk factors for post-TIPS OHE have been identified: age over 65 years, history of previous episodes of OHE, and Child-Pugh score equal to or over 10. However, the incidence of post-TIPS OHE in patients fulfilling these criteria remains close to 35 %.

Full description

TIPS has been used for 20 years, as a means of reducing portal pressure in patients with cirrhosis and portal hypertension related complications. TIPS proved more effective than alternative treatments in controlling or preventing variceal bleeding and refractory ascites. The main drawback of the TIPS procedure is progressive overt hepatic encephalopathy (OHE). Three risk factors for post-TIPS OHE have been identified: age over 65 years, history of previous episodes of OHE, and Child-Pugh score equal to or over 10. However, the incidence of post-TIPS OHE in patients fulfilling these criteria remains close to 35 %. Furthermore, the pathogenesis of HE in general but also in patients treated by TIPS is still not well understood. Therefore, there is a real challenge in discovering new molecular mechanisms involved in pathogenesis of OHE as well as new treatment to better prevent the risk of OHE in patients treated by TIPS. Observational and experimental studies suggest a microbiota's role in the mechanism of OHE and recently a non absorbable antibiotic has proven to reduce the risk of recurrence of OHE. However, the effect of this drug for the prevention of a first episode of OHE in patients treated by TIPS is not known. In addition, the mechanisms of the beneficial effect of rifaximin remain poorly understood.

Enrollment

211 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • cirrhosis with TIPS for ascit treatment or hydrothorax
  • prevention digestive bleeding follow up portal hypertension -
  • signed consent

Exclusion criteria

  • hepatocellular carcinoma out of Milan criteria or palliative phase cancer
  • Child Pugh score > 12
  • TIPS indicated for other indication than bellow
  • encephalopathy signs : asterixis or confusion
  • Hypersensibility to rifaximin, or derivated of rifamycin
  • Patients treated by same class antibacterial
  • pregnant woman
  • Patient with hepatic transplant

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

211 participants in 2 patient groups, including a placebo group

rifaximin
Experimental group
Description:
6 rifaximin caps of 200 mg per day morning and night, during 15 days before TIPS, and after TIPS during 6 months.
Treatment:
Drug: Rifaximin
placebo
Placebo Comparator group
Description:
6 caps placebo morning and night, 15 days before and 6 months after TIPS
Treatment:
Drug: placebo

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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