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

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ClinicalTrials.gov Identifier: NCT01848743
Recruitment Status : Unknown
Verified September 2014 by Wei-Lun Tsai, Kaohsiung Veterans General Hospital..
Recruitment status was:  Recruiting
First Posted : May 7, 2013
Last Update Posted : September 16, 2014
Sponsor:
Information provided by (Responsible Party):
Wei-Lun Tsai, Kaohsiung Veterans General Hospital.

Tracking Information
First Submitted Date  ICMJE April 24, 2013
First Posted Date  ICMJE May 7, 2013
Last Update Posted Date September 16, 2014
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
6 months survival [ Time Frame: 6 months after treatment begins ]
6 months survival after treatment begins
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tenofovir Versus Lamivudine for Patients of Chronic Hepatitis B With Severe Acute Exacerbation
Official Title  ICMJE Tenofovir Versus Lamivudine for Patients of Chronic Hepatitis B With Severe Acute Exacerbation
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic HBV With Severe Exacerbation
Intervention  ICMJE
  • Drug: Tenofovir
    Other Name: viread
  • Drug: lamivudine
    Other Name: zeffix
Study Arms  ICMJE
  • Active Comparator: Tenofovir
    All enrolled patients are randomized to tenofovir arm who receives tenofovir 300 mg qd for 36 months
    Intervention: Drug: Tenofovir
  • 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.
    Intervention: Drug: lamivudine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 3, 2013)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2016
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01848743
Other Study ID Numbers  ICMJE Gilead IN-US-174- 0190
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wei-Lun Tsai, Kaohsiung Veterans General Hospital.
Study Sponsor  ICMJE Kaohsiung Veterans General Hospital.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kaohsiung Veterans General Hospital.
Verification Date September 2014

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