Health Condition 1: K740- Hepatic fibrosis
Conditions
Interventions
Intervention1: Group 1 BCAA arm and placebo for rifaximin and lactulose: All investigators staff and participants will be blinded to treatment assignment. The active drug BCAA supplement (15 gm) once
Sponsors
MANKIND PHARMA LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1. Cirrhosis defined by standard clinical ultrasonographic findings andor 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 antiviral 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
Exclusion criteria: 1. Subjects with active bacterial or fungal infection 3. Subjects with active or very recent gastrointestinal bleeding in the last 2 weeks. 4.Current overt hepatic encephalopathy defined as grade II to IV hepatic encephalopathy according to the West Haven classification. 5. Conditions that can impact interpretation of cognitive function i) Untreated viremic hepatitis C virus infection ii) Established neurological or 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 6.Patients with active hepatocellular carcinoma or history of hepatocellular carcinoma that is in remission for less than six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ideal second line agent HE prophylaxis (rifaximin or BCAA) following 1st line lactulose is unclear in an Indian context where dysbiosis and sarcopenia are prevalent and cost of therapy needs to be optimized. Optimal HE management prevents recurrence episodes of HE, and improves prognosis, neurocognitive function and overall health-related quality of life(HRQOL).Timepoint: At Baseline and 4 Weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The same assessments will be performed as detailed above for Week 1assessment. Events including mortality or transplantation data hospital admissions and decompensation events will be collected up to 6 months from inclusion to evaluate outcomes and compare with baseline and delta changes in CL ART.Timepoint: 30 DAYS TO 90 DAYS | — |
Countries
India
Contacts
Public ContactPrerna Sharma
Post Graduate Institute of Medical Education and Research Chandigarh
Outcome results
None listed