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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01522625
Other study ID # EMRP36100N
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2012
Est. completion date December 2018

Study information

Verified date February 2019
Source E-DA Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date December 2018
Est. primary completion date November 2018
Accepts healthy volunteers No
Gender All
Age group 25 Years to 70 Years
Eligibility 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

Study Design


Intervention

Drug:
tenofovir disoproxil fumarate 300mg per day
tenofovir disoproxil fumarate 300mg per day for 3 years
Placebo
Placebo, identical to TDF in appearance, once daily for 3years

Locations

Country Name City State
Taiwan Chia-Yi Christine Hospital Chiayi City
Taiwan E-Da Hospital Kaohsiung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan Chi Mei Medical Center, Liouying Tainan
Taiwan Mackay Memorial Hosp Taipei
Taiwan National Taiwan University Hospital Yun-Lin Branch Yunlin

Sponsors (3)

Lead Sponsor Collaborator
E-DA Hospital Gilead Sciences, Taipei Institute of Pathology

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Severity of hepatic necroinflammation and fibrosis Primary outcome is the severity of necroinflammation and fibrosis in liver tissue as evaluated by Knodell and Ishak scoring system Within one month after completion of antiviral therapy
Secondary Undetectable hepatitis B viral DNA HBV DNA viral DNA not detected in serum Within one month after completion of antiviral therapy
Secondary Normalization of serum alanine aminotransferase serum ALT <40 IU/mL Within one month after completion of antiviral therapy
Secondary Serum level of HBsAg quantification of serum HBV serface antigen Within one month after completion of antiviral therapy
Secondary Serious adverse reaction Defined as death, life threatening event, permanent or temporary disability, and hospitalization Within one month after completion of antiviral therapy
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