BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE
Recruiting
Phase 4
Interventional Study
Hepatic Encephalopathy
Decompensated Cirrhosis
Minimal Hepatic Encephalopathy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 336 (estimated)
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh · Other
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About This Trial
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 health.
* A multicentric pan-India team will evaluate the role of oral branched-chain amino acids (BCAA) vs Rifaximin as secondary prophylaxis following overt HE as compared with improvement in cogniti…
Trial Locations
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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 incl…
Contacts