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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Kaohsiung Veterans General Hospital.
Sponsor:
Information provided by (Responsible Party):
Wei-Lun Tsai, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT01848743
First received: April 24, 2013
Last updated: September 12, 2014
Last verified: September 2014

April 24, 2013
September 12, 2014
April 2013
April 2016   (final data collection date for primary outcome measure)
6 months survival [ Time Frame: 6 months after treatment begins ] [ Designated as safety issue: No ]
6 months survival after treatment begins
Same as current
Complete list of historical versions of study NCT01848743 on ClinicalTrials.gov Archive Site
  • rapid virological response [ Time Frame: 1,2 and 4 weeks after treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Same as current
Not Provided
Not Provided
 
Tenofovir Versus Lamivudine for Patients of Chronic Hepatitis B With Severe Acute Exacerbation
Tenofovir Versus Lamivudine for Patients of Chronic Hepatitis B With Severe Acute Exacerbation

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic HBV With Severe Exacerbation
  • Drug: Tenofovir
    Other Name: viread
  • Drug: lamivudine
    Other Name: zeffix
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
October 2016
April 2016   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact: Wei-Lun Tsai, M.D. 886-7-3422121 ext 2075 tsaiwl@yahoo.com.tw
Contact: Hoi-Hung Chnan, M.D. , PhD 886-7-3422121 ext 2074 hhchan@vghks.gov.tw
Taiwan
 
NCT01848743
Gilead IN-US-174-​0190
Yes
Wei-Lun Tsai, Kaohsiung Veterans General Hospital.
Kaohsiung Veterans General Hospital.
Not Provided
Not Provided
Kaohsiung Veterans General Hospital.
September 2014

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