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Randomized Controlled Trial of Tenofovir in Patients of Reactivation of Hepatitis B Presenting as Acute on Chronic Liver Failure

Information source: Govind Ballabh Pant Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute on Chronic Liver Failure; Hepatitis B

Intervention: Tenofovir disoproxil fumarate (TDF) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Govind Ballabh Pant Hospital

Official(s) and/or principal investigator(s):
Shiv K Sarin, MD,DM, Principal Investigator, Affiliation: G.B. Pant Hospital, New Delhi, India

Summary

Background: Reactivation of hepatitis B is a well-characterized syndrome marked by the abrupt reappearance or rise of hepatitis B virus (HBV) DNA in the serum of a patient with previously inactive or resolved HBV infection. Reactivation can be spontaneous, but is most commonly triggered by cancer chemotherapy, immune suppression, or alteration in immune function. Spontaneous acute exacerbation of chronic hepatitis B infection is seen with a cumulative probability of 15±37% after 4 years of follow-up. 2 Significant number of patients of spontaneous acute exacerbation of chronic hepatitis B may present with very high ALT levels, jaundice and liver failure. 3 This condition should be defined as acute-on-chronic liver failure (ACLF) according to a recent Asia-Pacific consensus recommendation. The short term prognosis of patients of spontaneous acute exacerbation of chronic hepatitis B leading to ACLF like presentation is extremely poor, with a mortality of 30-70% in different series. 8,9,10 Liver transplantation has been the only definitive therapy available to salvage this group of patients. However ,this is not readily available and affordable. Another therapeutic option is antiviral therapy but has limited data. The efficacy of lamivudine was evaluated and compared by historical control but was not found to be beneficial. 8,9,10 However ,a study from Taiwan showed a survival benefit in a subgroup of patients who were on lamivudine and had baseline bilirubin below 342 mmol/L (20 mg/dL).11 Tenofovir disoproxil fumarate (TDF) is a potent, rapidly acting, oral acyclic nucleotide analogue, reverse transcriptase inhibitor that has been shown to be highly effective in suppressing hepatitis B virus replication. 12 Tenofovir has also shown excellent activity against HBV in both LAM- naïve and LAM-resistant patients. 13,14. Its efficacy has not been evaluated in patients of reactivation of hepatitis B who present as ACLF Hypothesis: The investigators hypothesis that Tenofovir reduces the morbidity and mortality in patients with Spontaneous reactivation of hepatitis B by reducing HBV DNA.

Clinical Details

Official title: Tenofovir Reduces Morbidity and Mortality in Patients With Spontaneous Reactivation of Hepatitis B Presenting as Acute-on-chronic Liver Failure (ACLF): A Randomized Placebo Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Reduction in HBV DNA levels, survival

Secondary outcome: Improvement in CTP, MELD scores

Eligibility

Minimum age: 2 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Reactivation of chronic hepatitis B characterized by rise in ALT level >5 times upper

limit of normal along with HBV DNA level >105 copies/ml (~1. 8x104 IU/ml) presenting as ACLF

- Acute hepatic insult

- Jaundice (bilirubin ≥5 mg/dL) and coagulopathy (INR>1. 5)

- Complicated within 4 weeks by ascites and/or encephalopathy in a patient with

previously diagnosed or undiagnosed chronic liver disease. Exclusion Criteria:

- Superinfection with other viruses (Hepatitis E, A, D and C)

- Coexistent hepatocellular carcinoma (HCC)

- Portal vein thrombosis

- Coexistent renal impairment

- Pregnancy

- Co-infection with HIV infection or Patients received previous course of any

antiviral

- Immunomodulator or cytotoxic/immunosuppressive therapy for chronic hepatitis or other

illness within at least the preceding 12 month.

Locations and Contacts

Department of Gastroenterology, GB Pant Hospital,, New Delhi, Delhi 110002, India
Additional Information

Starting date: November 2007
Last updated: February 23, 2010

Page last updated: August 23, 2015

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