Comparison Between Lamivudine and Entecavir Treatment in Patients (NUC115132)
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Purpose
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 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.
The efficacy and safety data will be collected at baseline, 3, 5, 8, 15, 22, 29 and 85 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis B |
Drug: Lamivudine Drug: Entecavir |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison Between Lamivudine and Entecavir Treatment in Patients With Spontaneous Severe Acute Exacerbation of Chronic Hepatitis B. |
- Overall survival (OS) rate during observational period [ Time Frame: day 0、3、5、8±2、15±3、22±3、29±3、85±7 ] [ Designated as safety issue: No ]To compare the overall survival (OS) rate during observational period between lamivudine and entecavir therapy.
- Change from baseline in HBV DNA level at each visit [ Time Frame: Change from baseline (day0) to day 3、5、8±2、15±3、22±3、29±3 ] [ Designated as safety issue: No ]To compare the change from baseline in HBV DNA level at each visit between lamivudine and entecavir therapy.
- Proportion of subjects with HBV DNA response at each visit [ Time Frame: day 0、3、5、8±2、15±3、22±3、29±3 ] [ Designated as safety issue: No ]To compare the proportion of subjects who have a ≥ 2 log10 decline from baseline in HBV DNA level at each visit between lamivudine and entecavir therapy.
- Change from baseline in ALT and AST level at each visit [ Time Frame: Change from baseline (day0) to day 3、5、8±2、15±3、22±3、29±3 ] [ Designated as safety issue: No ]To compare the change from baseline in ALT and AST level at each visit between lamivudine and entecavir therapy.
- Change from baseline in bilirubin level at each visit [ Time Frame: Change from baseline (day0) to day 3、5、8±2、15±3、22±3、29±3 ] [ Designated as safety issue: No ]To compare the change from baseline in bilirubin level at each visit between lamivudine and entecavir therapy.
- Proportion of subjects with prolonged PT at each visit [ Time Frame: day 0、3、5、8±2、15±3、22±3、29±3 ] [ Designated as safety issue: No ]To compare the proportion of subjects with prolonged prothrombin time (PT) at each visit between lamivudine and entecavir therapy.
- Transplantation-free survival rate during observational period [ Time Frame: day 0、3、5、8±2、15±3、22±3、29±3、85±7 ] [ Designated as safety issue: No ]To compare the transplantation-free survival rate during observational period between lamivudine and entecavir therapy.
- To assess the safety of lamivudine and entecavir treatments in patients with HBV-associated severe acute exacerbation. [ Time Frame: day 0 to day 85±7 ] [ Designated as safety issue: Yes ]
- Change in laboratory data
- Adverse events
- Serious adverse events (SAE)
| Estimated Enrollment: | 98 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
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: Lamivudine
Lamivudine 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. Other Name: Zeffix®
|
|
Experimental: Entecavir 0.5 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.
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. Other Name: Baraclude®
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female ≥ 20 years of age
- 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
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
- Patient with sufficient renal function defined as SCr ≤ 1.5 x ULN or ClCr ≥ 50 mL/min
- Willing and able to sign a written informed consent
Exclusion Criteria:
- Female who is pregnant/lactating
- Patient with underlying liver cirrhosis classified as Child-Pugh class B or C
- Patients with documented hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV) co-infection
- Patients with uncontrolled malignancy
- History or presence of alcohol or substance abuse within 1 year prior to the initiation of NRTI treatment
- History of hypersensitivity to any ingredient of observational drugs (Zeffix® or Baraclude®)
- Current use of medicine which may induce hepatotoxicity
- 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
- Use of any chemotherapy or immunosuppressive agents within 12 months prior to the initiation of NRTI treatment
- Use of any investigational product, including drug and invasive medical device, within 4 weeks prior to the initiation of NRTI treatment
- 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
Contacts and Locations| Contact: Sheng-Shun Yang, M.D. | 886-4-23592525 ext 3309 | yansh@vghtc.gov.tw |
| Contact: Teng-Yu Lee, M.D. | 886-4-23592525 ext 3301 | tylee@vghtc.gov.tw |
| Taiwan | |
| Changhua Christian Hospital | Recruiting |
| Changhua, Taiwan, 500 | |
| Contact: Yu-Chun Hsu, M.D. 886-4-7238595 ext 5505 77149@cch.org.tw | |
| Principal Investigator: Yu-Chun Hsu, M.D. | |
| Sub-Investigator: Shun-Sheng Wu, M.D. | |
| Sub-Investigator: Kai-Lun Shih, M.D. | |
| Sub-Investigator: Hsu-Heng Yen, M.D. | |
| Sub-Investigator: Pei-Yuan Su, M.D. | |
| Sub-Investigator: Wei-Wen Su, M.D. | |
| Chia-Yi Christian | Recruiting |
| ChiaYi, Taiwan | |
| Contact: Chi-Yi Chen, M.D. 886-5-2765041 ext 2536 chiyi.chen37@me.com | |
| Principal Investigator: Chi-Yi Chen, M.D. | |
| Taichung Veterans General Hospital | Recruiting |
| Taichung, Taiwan, 407 | |
| Contact: Sheng-Shun Yang, M.D. 886-4-23592525 ext 3309 yansh@vghtc.gov.tw | |
| Contact: Teng-Yu Lee, M.D. 886-4-23592525 ext 3307 tylee@vghtc.gov.tw | |
| Principal Investigator: Sheng-Shun Yang, M.D. | |
| Sub-Investigator: Teng Lee, M.D. | |
| ChengChing Hospital | Not yet recruiting |
| Taichung, Taiwan, 40764 | |
| Contact: Jen-Chieh Huang, M.D. 886-4-24632000 ext 55144 guthuang@yahoo.com.tw | |
| Principal Investigator: Jen-Chieh Huang, M.D. | |
| Sub-Investigator: Chi-Hung Chen, M.D. | |
| Tung's Taiching MetroHarbor Hospital | Not yet recruiting |
| Taichung, Taiwan, 435 | |
| Contact: Tsung-Ming Chen, M.D. 886-4-26581919 ext 4451 t4696@ms.sltung.com.tw | |
| Principal Investigator: Tsung-Ming Chen, M.D. | |
| China Medical University Hospital | Not yet recruiting |
| Taichung, Taiwan, 40447 | |
| Contact: Hsueh-Chou , Lai 886-4-22052121 ext 2260 t674233@ms54.hinet.net | |
| Principal Investigator: Hsueh-Chou Lai, M.D. | |
| Sub-Investigator: Jen-Wei Chou, M.D. | |
| Sub-Investigator: Jung-Ta Kao, M.D. | |
| Sub-Investigator: Wen-Pang Su, M.D. | |
| Chung Shan Medical University Hospital | Not yet recruiting |
| Taichung, Taiwan, 40201 | |
| Contact: Chun-Che Lin, M.D. 886-4-24739595 ext 38315 cshy333@csh.org.tw | |
| Principal Investigator: Chun-Che Lin, M.D. | |
| National Taiwan University Hospital Yu-Lin Branch | Not yet recruiting |
| YuLin, Taiwan, 640 | |
| Contact: Shih-Jer Hsu, M.D. 886-5-5323911 ext 2200 shihjer.hsu@gmail.com | |
| Principal Investigator: Shih-Jer Hsu, M.D. | |
| Principal Investigator: | Sheng-Shun Yang, M.D. | Taichung Veterans General Hospital |
| Principal Investigator: | Yu-Chun Hsu, M.D. | Changhua Christian Hospital |
| Principal Investigator: | Shih-Jer Hsu, M.D. | National Taiwan University Hospital Yu-Lin Branch |
| Principal Investigator: | Hsueh-Chou Lai, M.D. | China Medical University Hospital |
| Principal Investigator: | Chun-Che Lin, M.D. | Chung Shan Medical University Hospital |
| Principal Investigator: | Jen-Chieh Huang, M.D. | ChengChing Hospital |
| Principal Investigator: | Chi-Yi Chen, M.D. | Chia-Yi Christian |
| Principal Investigator: | Tsung-Ming Chen, M.D. | Tung's Taiching MetroHarbor Hospital |
More Information
No publications provided
| Responsible Party: | Sheng-Shun Yang, M.D. Division of Gastroenterology, Departmemt of Internal Medicine, Taichung Veterans General Hospital |
| ClinicalTrials.gov Identifier: | NCT01627223 History of Changes |
| Other Study ID Numbers: | NUC115132 |
| Study First Received: | June 18, 2012 |
| Last Updated: | February 18, 2013 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Taichung Veterans General Hospital:
|
Spontaneous Severe Acute Exacerbation of Chronic Hepatitis B Lamivudine (Zeffix®) Entecavir (Baraclude®) |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Hepatitis B, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections |
DNA Virus Infections Lamivudine Entecavir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 19, 2013