Status:
RECRUITING
BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Collaborating Sponsors:
Indian Council of Medical Research
Conditions:
Hepatic Encephalopathy
Decompensated Cirrhosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Rationale * Patients who recover from an episode of overt HE(OHE) are at risk of recurrent episodes of HE and persistent minimal hepatic encephalopathy, impacting their daily functioning and mental h...
Detailed Description
Hepatic encephalopathy (HE), a complex neuropsychiatric syndrome arising from liver dysfunction and the establishment of portosystemic shunts (PSS), presents a significant clinical challenge, marked b...
Eligibility Criteria
Inclusion
- 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.
- Any gender
- Discharged from the hospital following an episode of overt hepatic encephalopathy.
- Participants able to give informed consent
Exclusion
- Subjects with active bacterial or fungal infection
- Subjects with active or very recent gastrointestinal bleeding in the last 2 weeks.
- Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification.
- 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
- Patients with active hepatocellular carcinoma or history of hepatocellular carcinoma that is in remission for less than six months.
- 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.
- Patients with current extra hepatic malignancies, including solid tumours and hematologic disorders.
- Patients with MELD\>20
- 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.
- Patients with TIPS shunt in situ
- Pregnancy (urine pregnancy test at inclusion)
- Refusal or inability to give informed consent
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT06538077
Start Date
February 1 2025
End Date
August 1 2027
Last Update
June 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
PGIMER
Chandigarh, India