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New treatment option for Hepatic Encephalopathy
Official title BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE
ClinicalTrials.gov ID: NCT06538077
What this study is testing
What is Oral Branched chain Amino acid?
Oral Branched chain Amino acid is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hepatic encephalopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 cognitive function.
- Phase 4: studies an already-approved treatment
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Cirrhosis defined by standard clinical, ultrasonographic findings and/or histological criteria. Cirrhosis of any etiology may be included. However...
- Any gender
- Discharged from the hospital following an episode of overt hepatic encephalopathy.
- Participants able to give informed consent
You likely can't join if
- people with active bacterial or fungal infection
- people 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...
- 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...
See the full eligibility criteria
- 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...
- Any gender
- Discharged from the hospital following an episode of overt hepatic encephalopathy.
- Participants able to give informed consent
- people with active bacterial or fungal infection
- people 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...
- 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\ 2, ii) Chronic kidney...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chandigarh, India
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandigarh, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.