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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


Phase 4
2 Years
75 Years
Not Enrolling
Both
Acute on Chronic Liver Failure, Hepatitis B

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Reduction in HBV DNA levels, survival

Outcome Time Frame:

3 Month

Safety Issue:

Yes

Principal Investigator

Shiv K Sarin, MD,DM

Investigator Role:

Principal Investigator

Investigator Affiliation:

G.B. Pant Hospital, New Delhi, India

Authority:

India: Drugs Controller General of India

Study ID:

Hitendra garg

NCT ID:

NCT01074645

Start Date:

November 2007

Completion Date:

October 2009

Related Keywords:

  • Acute on Chronic Liver Failure
  • Hepatitis B
  • Acute-on -chronic liver failure
  • Reactivation of hepatitis B
  • Spontaneous reactivation of chronic hepatitis B presenting as to acute-on-chronic liver failure
  • Hepatitis
  • Hepatitis A
  • Hepatitis B
  • Liver Failure
  • End Stage Liver Disease

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