BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE

Launched by POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH · Jul 31, 2024

Keywords

ClinConnect Summary

This clinical trial is comparing two treatments—branched-chain amino acids (BCAA) and rifaximin—for patients with cirrhosis who have recently recovered from a serious liver condition called overt hepatic encephalopathy (HE). The goal is to find out which treatment is better at preventing future episodes of HE and improving overall mental function and quality of life. Participants will be randomly assigned to receive either BCAA or rifaximin, along with a placebo (a dummy pill that has no active ingredients), to help ensure the results are fair and unbiased.

To be eligible for this trial, participants need to be adults who have cirrhosis, have been discharged from the hospital after experiencing overt HE, and are able to give informed consent. However, individuals with certain conditions, such as active infections or severe liver disease, will not be included. Those who join the study can expect to take their assigned treatments for six months and will be monitored for any new episodes of HE and improvements in their mental health. This trial aims to provide valuable insights into the best ways to manage liver health and cognitive function in patients dealing with cirrhosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Cirrhosis defined by standard clinical, ultrasonographic findings and/or histological criteria. Cirrhosis of any etiology may be included. However, patients with cirrhosis due to autoimmune hepatitis must be on stable corticosteroid doses for ≥3-month period before study inclusion; those with viral hepatitis, must similarly be on anti-viral therapy with controlled viremia or with SVR.
• • 2. Any gender
• • 3. Discharged from the hospital following an episode of overt hepatic encephalopathy.
• • 4. Participants able to give informed consent
• Exclusion Criteria:
• • 1. Subjects with active bacterial or fungal infection
• • 2. Subjects with active or very recent gastrointestinal bleeding in the last 2 weeks.
• • 3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification.
• 4. Conditions that can impact interpretation of cognitive function:
• • i) Untreated viremic hepatitis C virus infection ii) Established neurological/degenerative disorders iii) Patient undergoing active alcohol withdrawal treatment Iv) Patient is intoxicated or under the influence of illicit drugs as per clinician assessment V) Treatment with antipsychotics or other psychotropic drugs with sedative effects
• • 5. Patients with active hepatocellular carcinoma or history of hepatocellular carcinoma that is in remission for less than six months.
• • 6. Patients with a history of significant extrahepatic disease with impaired short-term prognosis, including: i) Congestive heart failure New York Heart Association Grade III/IV or ejection fraction\<30% ii) COPD: GOLD \>2, ii) Chronic kidney disease with serum creatinine \>2mg/dL or under renal replacement therapy.
• • 7. Patients with current extra hepatic malignancies, including solid tumours and hematologic disorders.
• • 8. Patients with MELD\>20
• • 9. Patients with mental incapacity, or those unlikely to survive 12 weeks or any other reason considered by the investigator precluding adequate understanding, cooperation, or compliance in the study activities.
• • 10. Patients with TIPS shunt in situ
• • 11. Pregnancy (urine pregnancy test at inclusion)
• • 12. Refusal or inability to give informed consent