drugset / Trial / NCT04431375

Efficacy of Addition of Fecal Microbiota Transplant (FMT) and Plasma Exchange to Tenofovir in Comparison to Monotherapy With Tenofovir in ACLF-HBV

NCT04431375

RandomizedParallel-groupOpen-labelTreatment

Summary

A randomized controlled trial to study the efficacy of addition of FMT \& plasma exchange to tenofovir compared to monotherapy with tenofovir in patients with HBV reactivation who develops Acute on chronic liver failure. In this study the patients who meet the inclusion criteria will be randomized to either receive Tenofovir or with FMT + plasma exchange along with Tenofovir . Blood samples \& stool samples will be taken \& analysis will be done accordingly .The patients are followed for 90 days MELD,APACHE \& SOFA scores are calculated.Then statistical analysis will be done to find whether the addition of plasma exchange \& FMT adds benefit compared to tenofovir treatment alone .

Timeline

Start
2020-06-22
Primary completion
2022-06-10
Completion
2022-06-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenofovir Small molecule 300 mg Oral