Health Condition 1: B181- Chronic viral hepatitis B withoutdelta-agent Health Condition 2: K769- Liver disease, unspecified
Conditions
Interventions
Intervention1: Plasma Exchange,Tenofovir and FMT: Plasma exchange 2 sessions alternate day followed by FMT for 7 days and Tenofovir [antiviral] 300mg PO once a day
Control Intervention1: Tenofovir: Te
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age - 18-75 years 2) Patients with ACLF - HBV reactivation according to APASL guidelines. 3) MELD 4) MELD
Exclusion criteria
Exclusion criteria: 1) MELD > 30 2) Co existing hepatitis A,E,D 3) HCC 4) Sepsis 5) Alcohol intake, substance abuse, HIV, IBD, chronic constipation or diarrhoea 6) Allergy to plasma, protamine or heparin, 7) Active hemorrhage or disseminated intravascular coagulation (DIC) 8) Unstable hemodynamics (e.g., blood pressure 100 bpm), 9) Cerebral or myocardiac infarction 10) Pregnancy
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events in both groupsTimepoint: 90 days;Change in microbiota bacteria profileTimepoint: 10,30,60 and 90 days;Change in plasma cytokine profileTimepoint: 10,28 and 60 days;Improvement in CTP and MELD ScoresTimepoint: 14,30,60 and 90 days;Overall survival at 3 monthsTimepoint: 3 months;Reduction in HBV DNA levelTimepoint: 14,60 and 90 days | — |
Primary
| Measure | Time frame |
|---|---|
| Overall survival at 28 days.Timepoint: 28 days | — |
Countries
India
Contacts
Public ContactDr Shiv Kumar Sarin
Institute of Liver and Biliary Sciences
Outcome results
None listed