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Chronic Hepatitis B | Comparison Between Lamivudine and Entecavir Treatment in Spontaneous Severe Acute Exacerbation

Chronic Hepatitis B research study

What is the primary objective of this study?

This is a prospective, observational, open-label, 2-arm, parallel, multi-center study. Patients with HBV-associated severe acute exacerbation for whom the treatment with NRTI (such as lamivudine and entecavir) is medically recommended will be screened for eligibility. To target 74 evaluable subjects, approximately 82 patients should be recruited into this trial. After enrollment, all eligible subjects will be randomly assigned to one of the antiviral treatments below. - Cohort 1: Lamivudine 100 mg p.o. q.d. - Cohort 2: Entecavir 0.5 mg p.o. q.d. This process will be stratified by prolonged PT, < 4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and the first dose of observational drug should be administered on Day 1. The observational period of individual subject will be 12 weeks; however, both treatments could be continued after the end of study based on physician's clinical judgment. The efficacy and safety data will be collected at baseline, 3, 5, 8, 15, 22, 29, 85, and 180 days after initiation of antiviral treatment. All assessments should be conducted based on routine practice of each hospital. Only the analysis of HBV DNA and anti-HDV will be performed in the central lab. For patients who are willing to provide the residual samples of HBV DNA assessment, the blood samples will be preserved appropriately. All AE(s) and SAE will be followed until resolution or the event is considered stable.

Who is eligible to participate?

Inclusion Criteria: 1. Male or female ≥ 20 years of age 2. HBsAg carrier with spontaneously severe acute exacerbation for whom the treatment with nucleoside and nucleotide reverse transcriptase inhibitor (NRTI) such as lamivudine and entecavir is medically recommended 3. Patients who fulfills all of the following criteria at screening: - documented HBsAg positive for at least 6 months or anti-HBc IgM negative - HBV DNA ≥ 2,000 IU/mL* * The blood sample will be collected at screening visit, but this criterion will be checked after obtaining lab result. For patients fulfill all other criteria, they can be enrolled immediately. - total bilirubin ≥ 2 mg/dL or prolonged prothrombin time (PT) ≥ 3 sec - serum ALT ≥ 10 x ULN 4. Patient with sufficient renal function defined as SCr ≤ 1.5 x ULN or ClCr ≥ 50 mL/min 5. Willing and able to sign a written informed consent Exclusion Criteria: 1. Female who is pregnant/lactating 2. Patient with underlying liver cirrhosis classified as Child-Pugh class B or C 3. Patients with documented hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV) co-infection 4. Patients with uncontrolled malignancy 5. History or presence of alcohol or substance abuse within 1 year prior to the initiation of NRTI treatment 6. History of hypersensitivity to any ingredient of observational drugs (Zeffix® or Baraclude®) 7. Current use of medicine which may induce hepatotoxicity 8. Use of any antiviral therapy for HBV, such as interferon-α (IFN-α) and other nucleotide/nucleoside analogues, within 6 months prior to the initiation of NRTI treatment or exposure to any treatment for more than 3 months 9. Use of any chemotherapy or immunosuppressive agents within 12 months prior to the initiation of NRTI treatment 10. Use of any investigational product, including drug and invasive medical device, within 4 weeks prior to the initiation of NRTI treatment 11. Patient with any medical or psychiatric condition, including the presence of significant abnormal laboratory values, which is considered not suitable for this study by investigator

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Chronic Hepatitis B

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:LamivudineLamivudine 100 mg p.o. q.d. This process will be stratified by prolonged PT, < 4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and the first dose of observational drug should be administered on Day 1. The observational period of individual subject will be 12 weeks; however, both treatments could be continued after the end of study based on physician's clinical judgment.

Drug:Entecavir•Entecavir 0.5 mg p.o. q.d This process will be stratified by prolonged PT, < 4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and the first dose of observational drug should be administered on Day 1. The observational period of individual subject will be 12 weeks; however, both treatments could be continued after the end of study based on physician's clinical judgment.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Lamivudine 100 mg p.o. q.d.To target 88 evaluable subjects, approximately 98 patients should be recruited into this trial. After enrollment, all eligible subjects will be randomly assigned to one of the antiviral treatments below. Cohort 1: Lamivudine 100 mg p.o. q.d. Cohort 2: Entecavir 0.5 mg p.o. q.d. This process will be stratified by prolonged PT, < 4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and the first dose of observational drug should be administered on Day 1. The observational period of individual subject will be 12 weeks; however, both treatments could be continued after the end of study based on physician's clinical judgment.

Entecavir 0.5 mg p.o. q.dTo target 88 evaluable subjects, approximately 98 patients should be recruited into this trial. After enrollment, all eligible subjects will be randomly assigned to one of the antiviral treatments below. Cohort 1: Lamivudine 100 mg p.o. q.d. Cohort 2: Entecavir 0.5 mg p.o. q.d. This process will be stratified by prolonged PT, < 4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and the first dose of observational drug should be administered on Day 1. The observational period of individual subject will be 12 weeks; however, both treatments could be continued after the end of study based on physician's clinical judgment.

Study Status

Terminated

Start Date: July 2012

Completed Date: April 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Change from baseline in HBV DNA level at each visit

Secondary Outcome: Overall survival (OS) rate during observational period

Study sponsors, principal investigator, and references

Principal Investigator: Sheng-Shun Yang, M.D.

Lead Sponsor: Taichung Veterans General Hospital

Collaborator: GlaxoSmithKline

More information:https://clinicaltrials.gov/show/NCT01627223

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