Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Chronic HBV With Severe Exacerbation Drug: Tenofovir Drug: lamivudine Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tenofovir Versus Lamivudine for Patients of Chronic Hepatitis B With Severe Acute Exacerbation
Study Start Date : April 2013
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 6 months survival [ Time Frame: 6 months after treatment begins ]
    6 months survival after treatment begins


Secondary Outcome Measures :
  1. 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

  2. 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

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848743


Contacts
Layout table for location contacts
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

Locations
Layout table for location information
Taiwan
Kaohsiung Veterans General Hospigal Recruiting
Kaohsiung, Taiwan, 813
Contact: Wei-Lun Tsai, MD    886-7-3422121 ext 2075    tsaiwl@yahoo.com.tw   
Contact: Hi-Hung Chan, MD, PhD    886-7-3422121 ext 2074    hhchan@vghks.gov.tw   
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Wei-Lun Tsai, Attending physician, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT01848743    
Other Study ID Numbers: Gilead IN-US-174- 0190
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014
Keywords provided by Wei-Lun Tsai, Kaohsiung Veterans General Hospital.:
tenofovir, lamivudine, hepatitis B, acute exacerbation
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
 Tenofovir
Lamivudine
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