Status:
UNKNOWN
Efficacy of Addition of Fecal Microbiota Transplant (FMT) and Plasma Exchange to Tenofovir in Comparison to Monotherapy With Tenofovir in ACLF-HBV
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Acute-On-Chronic Liver Failure
Hepatitis B
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 ch...
Detailed Description
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 ch...
Eligibility Criteria
Inclusion
- Age - 18-75 years
- Patients with ACLF - HBV reactivation according to APASL guidelines.
- MELD \< 30 WITH AKI,HE
- MELD \< 30 WITH OUT EXTRAHEPATIC FAILURE
Exclusion
- MELD \> 30
- Co existing hepatitis A,E,D
- HCC
- Sepsis
- Alcohol intake, substance abuse, HIV, IBD, chronic constipation or diarrhoea
- Allergy to plasma, protamine or heparin,
- Active hemorrhage or disseminated intravascular coagulation (DIC)
- Unstable hemodynamics (e.g., blood pressure \<90/60 mmHg, heart rate \>100 bpm),
- Cerebral or myocardiac infarction
- Pregnancy
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 10 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04431375
Start Date
June 22 2020
End Date
June 10 2022
Last Update
January 31 2022
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070