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Tenofovir in Chronic Hepatitis B With Mild ALT Elevation

This study is currently recruiting participants.
Verified October 2012 by E-DA Hospital
Sponsor:
Collaborators:
Gilead Sciences
Taipei Institute of Pathology, Taiwan
Information provided by (Responsible Party):
Hung Chi Chen, E-DA Hospital
ClinicalTrials.gov Identifier:
NCT01522625
First received: January 27, 2012
Last updated: October 14, 2012
Last verified: October 2012
History of Changes

January 27, 2012
October 14, 2012
January 2012
January 2015   (final data collection date for primary outcome measure)
Severity of hepatic necroinflammation and fibrosis [ Time Frame: Within one month after completion of antiviral therapy ] [ Designated as safety issue: No ]
Primary outcome is the severity of necroinflammation and fibrosis in liver tissue as evaluated by Knodell and Ishak scoring system
Same as current
Complete list of historical versions of study NCT01522625 on ClinicalTrials.gov Archive Site
  • Undetectable hepatitis B viral DNA [ Time Frame: Within one month after completion of antiviral therapy ] [ Designated as safety issue: No ]
    HBV DNA viral DNA not detected in serum
  • Normalization of serum alanine aminotransferase [ Time Frame: Within one month after completion of antiviral therapy ] [ Designated as safety issue: No ]
    serum ALT <40 IU/mL
  • Serum level of HBsAg [ Time Frame: Within one month after completion of antiviral therapy ] [ Designated as safety issue: No ]
    quantification of serum HBV serface antigen
  • Serious adverse reaction [ Time Frame: Within one month after completion of antiviral therapy ] [ Designated as safety issue: Yes ]
    Defined as death, life threatening event, permanent or temporary disability, and hospitalization
Same as current
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Chronic Hepatitis B
  • Drug: tenofovir disoproxil fumarate 300mg per day
    tenofovir disoproxil fumarate 300mg per day for 3 years
    Other Name: Viread® (Gilead Sciences Inc)
  • Drug: Placebo
    Placebo, identical to TDF in appearance, once daily for 3years
  • Experimental: TDF
    tenofovir disoproxil fumarate (TDF) 300mg
    Intervention: Drug: tenofovir disoproxil fumarate 300mg per day
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
December 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
25 Years to 70 Years
No
Contact: Jaw-Town Lin, MD,PhD. 886-2-23123456 ext 62246 jawtown@ntu.edu.tw
Contact: Yao-Chun Hsu, MD, MSc 886-7-6150011 ext 2980 gatsbyhsu@yahoo.com.tw
Taiwan
 
NCT01522625
EMRP36100N
No
Hung Chi Chen, E-DA Hospital
E-DA Hospital
  • Gilead Sciences
  • Taipei Institute of Pathology, Taiwan
Principal Investigator: Yao-Chun Hsu, MD, MSc E-Da Hospital, Kaohsiung, Taiwan
Study Chair: Jaw-Town Lin, MD, PhD National Taiwan University
E-DA Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP