NCT01522625

Tenofovir in Chronic Hepatitis B With Mild ALT Elevation

Efficacy of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients With High Viral Load But Slight Aminotransferase Elevation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: E-DA Hospital · Academic / Other
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims to clarify whether patients with chronic hepatitis B with high viral load will benefit from oral antiviral therapy despite only mildly elevated serum liver enzyme.

Detailed description

Chronic hepatitis B (CHB) is a serious disease in Taiwan, leading to substantial morbidity and mortality including hepatic failure, liver cirrhosis, and hepatocellular carcinoma (HCC). Recently a large body of evidence supports that high level of serum HBV DNA is an independent risk factor for late complications in CHB patients. Nucleos(t)ide analogues (NUC) are effective antiviral therapy that can potently inhibit replication of hepatitis B virus (HBV), and has been widely used in management of patients with CHB. Current practice guidelines recommend using serum alanine aminotransferase (ALT) \> 2 times of the upper limit of normal (ULN) as the prerequisite to initiate antiviral therapy in compensated CHB patients without liver cirrhosis. However, serum ALT level does not exactly correlate with serum HBV DNA or liver tissue injury. Whether antiviral therapy improves outcomes of patients with slightly elevated ALT (i.e. 1-2 folds of ULN) remains unknown.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	tenofovir disoproxil fumarate 300mg per day	tenofovir disoproxil fumarate 300mg per day for 3 years
DRUG	Placebo	Placebo, identical to TDF in appearance, once daily for 3years

Timeline

• Start date: 2012-01-01
• Primary completion: 2018-11-01
• Completion: 2018-12-01
• First posted: 2012-01-31
• Last updated: 2019-02-12

Locations

6 sites across 1 country: Taiwan