- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02689245
Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure.
Data for stool microbiome will be collected for all the chronic hepatitis B subjects (pre cirrhotic,compensated,decompensated and reactivation). All the in and out patient with Hepatitis B reactivation will be recruited and randomized into two arms.
Group 1 Tenofovir Group 2 Tenofovir with FMT (Fecal Microbiota Transplant).
Tenofovir would be given 300 mg once daily FMT through NJ (Naso-Jejunal) tube for 7 days.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110070
- Institute of liver and Biliary Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Reactivation of Chronic Hepatitis B Virus leads to Acute on Chronic Liver Failure- (MELD (Model for End Stage liver Disease) >18 years.
- 18-75 yr both male and female
- Chronic Hepatitis B patient (precirrhotic,compensated,decompensated).
- Healthy adult family member of the patient will be taken as a control.
Exclusion Criteria:
- Acute on Chronic Liver Failure due to other causes -Alcohol,Hepatitis A Virus,Hepatitis E Virus,HSV (Herpes Simplex Virus),CMV (Cytomegalovirus),EBV (Epstein-Barr Virus) other hepatotropic virus,Drugs,CAM.
- Active gastrointestinal bleeding
- Intracranial bleeding
- Multi-organ failure (>2) on mechanical ventilation
- SOFA score >2
- On high inotropic support
- Paralytic ileus
- Pregnancy
- Hepatocellular Carcinoma
- Antibiotic,probiotic within last 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Tenofovir
|
|
Experimental: Tenofovir + Fecal Microbiota Transplantation (FMT)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Transplant free survival.
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in Hepatitis B Virus DNA level ≥ 2 log.
Time Frame: 2 weeks
|
2 weeks
|
|
Improvement in MELD (Model for End Stage Liver Disease) score.
Time Frame: 2 weeks
|
2 weeks
|
|
Improvement in CTP (Child Pugh Turcotte) score.
Time Frame: 2 weeks
|
2 weeks
|
|
Mortality
Time Frame: 1 Month
|
1 Month
|
|
Mortality
Time Frame: 3 Months
|
3 Months
|
|
Improvement in hepatic Encephalopathy.
Time Frame: 7 days
|
Improvement is defined as reduction in grading (severity) of hepatic encephalopathy from baseline value.
|
7 days
|
Improvement in International Normalized ratio.
Time Frame: 7 days
|
Improvement is defined as International Normalized ratio value within normal limits
|
7 days
|
Improvement in Total bilirubin.
Time Frame: 7 days
|
Improvement is defined as Total bilirubin value within normal limits.
|
7 days
|
Development of infectious complications during follow up in both groups
Time Frame: 7,15,30 and 90 days
|
7,15,30 and 90 days
|
|
Improvement in APACHE (Acute Physiology and Chronic Health Evaluation) score in both groups
Time Frame: 7,15,30 and 90 days
|
7,15,30 and 90 days
|
|
Improvement in SOFA (Sequential organ failure assessment) score in both groups.
Time Frame: 7,15,30 and 90 days
|
7,15,30 and 90 days
|
|
Change in gut microbiome in both the groups
Time Frame: 0,7,15,30 and 90 days
|
0,7,15,30 and 90 days
|
|
Assessment of organ failures in both groups
Time Frame: 7,15,30 and 90 days
|
7,15,30 and 90 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dr Juned Ahmad, MD, Institute of liver and Biliary Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Liver Failure, Acute
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Hepatitis
- End Stage Liver Disease
- Liver Failure
- Hepatic Insufficiency
- Acute-On-Chronic Liver Failure
- Hepatitis B
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
Other Study ID Numbers
- ILBS-ACLF-007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute on Chronic Liver Failure
-
Chulalongkorn UniversityRecruitingAcute-On-Chronic Liver Failure | Acute on Chronic Hepatic FailureThailand
-
Third Affiliated Hospital, Sun Yat-Sen UniversityWithdrawnLiver Failure, Acute on ChronicChina
-
Tianjin Weikai Bioeng., Ltd.Tianjin Nankai HospitalUnknownLiver Failure, Acute on ChronicChina
-
Aga Khan UniversityNational Institute of Liver & GI Diseases, PakistanNot yet recruiting
-
Nanfang Hospital of Southern Medical UniversityCompletedLiver Injury | Liver Failure, Acute on Chronic
-
Pere GinesClinica Universidad de Navarra, Universidad de NavarraTerminatedAllogenic Bone Marrow Mesenchymal Stem Cell Therapy in Acute-on-chronic Liver Failure (Liveradvance)Acute on Chronic Hepatic FailureSpain
-
Nanfang Hospital of Southern Medical UniversityCompletedThrombelastography,Acute on Chronic Liver Failure, PlateletChina
-
Hexaell Biotech Co., Ltd.RecruitingLiver Failure | Hepatitis | Acute on Chronic Hepatic FailureChina
-
Hepa Wash GmbHTerminatedAcute on Chronic Hepatic FailureGermany
-
Institute of Liver and Biliary Sciences, IndiaCompletedAcute on Chronic Hepatic FailureIndia
Clinical Trials on Tenofovir
-
National Institute of Allergy and Infectious Diseases...Microbicide Trials NetworkCompletedHIV InfectionsSouth Africa, Uganda, Zimbabwe
-
CONRADNational Institute of Allergy and Infectious Diseases (NIAID)Completed
-
National Institute of Allergy and Infectious Diseases...Microbicide Trials NetworkCompleted
-
Mahidol UniversityRecruitingRenal Insufficiency | TenofovirThailand
-
French National Agency for Research on AIDS and...Gilead Sciences; PharmassetTerminatedHBe Negative Chronic Hepatitis B | Hepatitis B Viral InfectionFrance
-
AIDS Clinical Trials GroupNational Institute of Allergy and Infectious Diseases (NIAID)RecruitingHIV InfectionsUnited States
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedHIV InfectionsUnited States, Puerto Rico
-
Eastern Virginia Medical SchoolGilead Sciences; United States Agency for International Development (USAID); FHI... and other collaboratorsActive, not recruitingAdherence, Medication | Acceptability of Health CareSouth Africa, Zimbabwe
-
CONRADEastern Virginia Medical School; University of North Carolina; Agility Clinical...Completed
-
Merck Sharp & Dohme LLCCompleted