Tenofovir in Chronic Hepatitis B With Mild ALT Elevation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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

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Chronic Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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TDF

tenofovir disoproxil fumarate (TDF) 300mg

Group Type EXPERIMENTAL

tenofovir disoproxil fumarate 300mg per day

Intervention Type DRUG

tenofovir disoproxil fumarate 300mg per day for 3 years

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, identical to TDF in appearance, once daily for 3years

Interventions

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tenofovir disoproxil fumarate 300mg per day

tenofovir disoproxil fumarate 300mg per day for 3 years

Intervention Type DRUG

Placebo

Placebo, identical to TDF in appearance, once daily for 3years

Intervention Type DRUG

Other Intervention Names

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Viread® (Gilead Sciences Inc)

Eligibility Criteria

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Inclusion Criteria

* age between 25 to 70 years,
* serum HBsAg positivity for more than 6 months,
* positive or negative serum HBeAg,
* serum HBV DNA more than 2,000 IU/mL,
* highest serum ALT \> 1 fold of ULN, but \< 2 X ULN on at least two occasions (≧ 3 months apart) in the preceding one year,

Exclusion Criteria

* co-infection with HIV, HCV, or HDV,
* previous exposure to HBV antiviral therapy for more than 12 weeks,
* presence of cirrhosis on histopathology,
* hepatic decompensation defined as serum bilirubin \> 2mg/dl and prolonged prothrombin time \> 3 seconds,
* concurrent malignant diseases including hepatocellular carcinoma,
* severe co-morbidity with life expectancy \< 1year,
* pregnant or lactating women,
* organ transplantation except cornea or hair transplant,
* suspected or confirmed chronic liver diseases from etiologies other than HBV (e.g. alcoholic hepatitis, Wilson disease, Hemochromatosis…etc),
* serum creatinine \>1.5mg/dL

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No