Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Tenofovir Versus Lamivudine for Patients of Chronic Hepatitis B With Severe Acute Exacerbation (HBSAE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Kaohsiung Veterans General Hospital..
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Wei-Lun Tsai, Kaohsiung Veterans General Hospital. Identifier:
First received: April 24, 2013
Last updated: September 12, 2014
Last verified: September 2014

In Taiwan, 15% of general population had hepatitis B virus (HBV) infection, HBV is the leading cause of liver cirrhosis and hepatocellular carcinoma in Taiwan. After entering immune clearance, 10-30% of patients of chronic HBV develop acute exacerbation (AE) , some are mild but some developed hepatic decompensation or even death.

Previous study found that early use of lamivudine before bilirubin level is above 20 mg/dl can improve survival in chornic HBV with severe AE. From the study from Hongkong, lamivudine was found to have better survival than entecavir in chronic HBV with severe AE. Recent study from India found that tenofovir is able to improve survival in chronic HBV with severe AE. The aim of this study is to compare the effect of lamivudine and tenofovir for chronic HBV with severe AE.

The study aims to enroll 120 patients with chronic HBV defined as persistence of HBsAg for more than 6 months. Severe AE was defined as ALT > 400 U/L, prolongation of prothrombin time > 3 seconds, bilirubin > 2 mg/dl. Patients with hepatitis A, C, D or HIV infection, drug or alcoholic liver disease, hepatocellular carcinoma, under immuno-suppressive agents use, or previous use of anti-HBV agents are excluded. All enrolled patients are randomized into group A who received tenofovir 300 mg qd for 3 years and group B who received lamivuidne 100 mg qd for 6 months, followed by tenofovir 300mg qd for 30 months. Mortality rate and virological, biochemical and serological response were evaluated at 1,2,4,48,96 and 144 weeks. The values are expressed as mean + SD. Categorical variables were analyzed with Chi-square test or Fisher's exact test as appropriate and continuous variables were analyzed by Mann-Whitney test. Logistic regression test was applied to analyze the independent association of various variables with outcome. A p value < 0.05 was regarded as significant.

Condition Intervention Phase
Chronic HBV With Severe Exacerbation
Drug: Tenofovir
Drug: lamivudine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tenofovir Versus Lamivudine for Patients of Chronic Hepatitis B With Severe Acute Exacerbation

Resource links provided by NLM:

Further study details as provided by Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • 6 months survival [ Time Frame: 6 months after treatment begins ]
    6 months survival after treatment begins

Secondary Outcome Measures:
  • rapid virological response [ Time Frame: 1,2 and 4 weeks after treatment ]
    Evaluate the relationship of rapid virological response ( at 1,2 and 4 weeks) and survival

  • HBeAg seroconversion and virological response 1, 2, and 3 years after treatment [ Time Frame: 1,2 and 3 years after treatment ]
    To evaluate the rate of HBeAg seroconversion and virological response 1, 2, and 3 years after treatment in the two arms

  • Safety profile [ Time Frame: during and 6 months after treatment ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Estimated Enrollment: 120
Study Start Date: April 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tenofovir
All enrolled patients are randomized to tenofovir arm who receives tenofovir 300 mg qd for 36 months
Drug: Tenofovir
Other Name: viread
Placebo Comparator: lamivudine
All enrolled patients are randomized to lamivudine arm who received lamivudine 100 mg qd for 6 months, followed by tenofovir for another 30 months.
Drug: lamivudine
Other Name: zeffix


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HBsAg (+) > 6 months
  • ALT > 5X ULN
  • Prolongation of prothrombin time > 3 seconds and bilirubin level > 2 mg/dl
  • 20-75 years old

Exclusion Criteria:

  • HAV, HCV, HDV and HIV co-infection
  • Concurrent hepatocellular carcinoma
  • Drug, metabolic or alcohol as cause of hepatitis
  • Anti-viral treatment in recent 6 mnths
  • Pregnant woman
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01848743

Contact: Wei-Lun Tsai, M.D. 886-7-3422121 ext 2075
Contact: Hoi-Hung Chnan, M.D. , PhD 886-7-3422121 ext 2074

Kaohsiung Veterans General Hospigal Recruiting
Kaohsiung, Taiwan, 813
Contact: Wei-Lun Tsai, MD    886-7-3422121 ext 2075   
Contact: Hi-Hung Chan, MD, PhD    886-7-3422121 ext 2074   
Principal Investigator: Wei-Lun Tsai, MD         
Kaohsiung Veterans General Hospital Active, not recruiting
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
  More Information

Responsible Party: Wei-Lun Tsai, Attending physician, Kaohsiung Veterans General Hospital. Identifier: NCT01848743     History of Changes
Other Study ID Numbers: Gilead IN-US-174- 0190
Study First Received: April 24, 2013
Last Updated: September 12, 2014

Keywords provided by Kaohsiung Veterans General Hospital.:
tenofovir, lamivudine, hepatitis B, acute exacerbation

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents processed this record on May 22, 2017