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Trial record 122 of 351 for:    hepatitis b | Open Studies

Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure.

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Institute of Liver and Biliary Sciences, India
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT02689245
First received: February 13, 2016
Last updated: October 5, 2016
Last verified: September 2016
  Purpose

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.


Condition Intervention
Acute on Chronic Liver Failure
Drug: Tenofovir
Drug: Fecal Microbiota Transplantation (FMT)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure.

Resource links provided by NLM:


Further study details as provided by Institute of Liver and Biliary Sciences, India:

Primary Outcome Measures:
  • Transplant free survival. [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Reduction in Hepatitis B Virus DNA level ≥ 2 log. [ Time Frame: 2 weeks ]
  • Improvement in MELD (Model for End Stage Liver Disease) score. [ Time Frame: 2 weeks ]
  • Improvement in CTP (Child Pugh Turcotte) score. [ Time Frame: 2 weeks ]
  • Mortality [ Time Frame: 1 Month ]
  • Mortality [ Time Frame: 3 Months ]
  • Improvement in hepatic Encephalopathy. [ Time Frame: 7 days ]
    Improvement is defined as reduction in grading (severity) of hepatic encephalopathy from baseline value.

  • Improvement in International Normalized ratio. [ Time Frame: 7 days ]
    Improvement is defined as International Normalized ratio value within normal limits

  • Improvement in Total bilirubin. [ Time Frame: 7 days ]
    Improvement is defined as Total bilirubin value within normal limits.

  • Development of infectious complications during follow up in both groups [ Time Frame: 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 ]
  • Improvement in SOFA (Sequential organ failure assessment) score in both groups. [ Time Frame: 7,15,30 and 90 days ]
  • Change in gut microbiome in both the groups [ Time Frame: 0,7,15,30 and 90 days ]
  • Assessment of organ failures in both groups [ Time Frame: 7,15,30 and 90 days ]

Estimated Enrollment: 130
Study Start Date: February 2016
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tenofovir + Fecal Microbiota Transplantation (FMT) Drug: Tenofovir Drug: Fecal Microbiota Transplantation (FMT)
Active Comparator: Tenofovir Drug: Tenofovir

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Reactivation of Chronic Hepatitis B Virus leads to Acute on Chronic Liver Failure- (MELD (Model for End Stage liver Disease) >18 years.
  2. 18-75 yr both male and female
  3. Chronic Hepatitis B patient (precirrhotic,compensated,decompensated).
  4. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02689245

Contacts
Contact: Dr Juned Ahmad, MD 011-46300000 ahmadjuned43.jk@gmail.com

Locations
India
Institute of liver and Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
Principal Investigator: Dr Juned Ahmad, MD Institute of Liver and Biliary Sciences
  More Information

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT02689245     History of Changes
Other Study ID Numbers: ILBS-ACLF-007
Study First Received: February 13, 2016
Last Updated: October 5, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hepatitis B
Hepatitis, Viral, Human
Hepatitis
Liver Failure
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatic Insufficiency
Liver Failure, Acute
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on March 28, 2017