Efficacy of Addition of Fecal Microbiota Transplant (FMT) and Plasma Exchange to Tenofovir in Comparison to Monotherapy With Tenofovir in ACLF-HBV
1 other identifier
interventional
70
1 country
1
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 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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedStudy Start
First participant enrolled
June 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2022
CompletedJanuary 31, 2022
January 1, 2022
2 years
June 4, 2020
January 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival in both groups
Day 28
Secondary Outcomes (27)
Overall survival in both groups
3 months
Reduction in HBV DNA level
14 days
Reduction in HBV DNA level
60 days
Reduction in HBV DNA level
90 days
Reduction in CTP Score in both groups
14 days
- +22 more secondary outcomes
Study Arms (2)
plasma Exchange+Tenofovir+FMT
EXPERIMENTALSubjects will receive Plasma exchange 2 sessions alternate day followed by FMT for 7 days and Tenofovir \[antiviral\] 300mg PO once a day .
Tenofovir
ACTIVE COMPARATORTabletTenofovir \[antiviral\] 300mg per oral once a day
Interventions
Plasma exchange 2 sessions alternate day followed by FMT for 7 days and Tenofovir \[antiviral\] 300mg PO once a day .
Eligibility Criteria
You may qualify if:
- Age - 18-75 years
- Patients with ACLF - HBV reactivation according to APASL guidelines.
- MELD \< 30 WITH AKI,HE
- MELD \< 30 WITH OUT EXTRAHEPATIC FAILURE
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2020
First Posted
June 16, 2020
Study Start
June 22, 2020
Primary Completion
June 10, 2022
Study Completion
June 10, 2022
Last Updated
January 31, 2022
Record last verified: 2022-01