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Oxymatrine Plus Lamivudine Combination Therapy Versus Lamivudine Monotherapy for Chronic Hepatitis B Infected Subjects

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ClinicalTrials.gov Identifier: NCT02202473
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : July 29, 2014
Sponsor:
Collaborator:
Cttq
Information provided by (Responsible Party):
Wei Zhao, Southeast University, China

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy of Oxymatrine plus Lamivudine Combination Therapy and whether it could lower the incidence of Lamivudine long-term resistance compared to Lamivudine Monotherapy.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Lamivudine Drug: Lamivudine+Oxymatrine Capsules Phase 4

Detailed Description:

Group A (Lamivudine Monotherapy): Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd.

Group B (Oxymatrine + Lamivudine Combination Therapy): Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd; oxymatrine Capsules (Chia Tai Tianqing Pharmaceutical Group Co., Ltd) 200 mg, po, tid.

Total subjects: 200, 100 patients randomized in each group.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Primary Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Lamivudine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Lamivudine
Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd
 Drug: Lamivudine
Experimental: Lamivudine+Oxymatrine Capsules
Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd; oxymatrine Capsules (Chia Tai Tianqing Pharmaceutical Group Co., Ltd) 200 mg, po, tid.
 Drug: Lamivudine+Oxymatrine Capsules


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of Hepatitis B virus DNA titer compared to Baseline Hepatitis B virus DNA titer every 3 months for 18 months [ Time Frame: 1, 3, 6, 12, 15, 18 months ]

Secondary Outcome Measures :
  1. Hepatitis B virus resistance loci [ Time Frame: 1, 3, 6, 12, 15, 18 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 to 60 years old.
  2. Subjects diagnosed as chronic hepatitis B according to 2000 Xi'an Conference Guidelines: Management of chronic hepatitis B. Alanine transaminase >80 IU/L, total bilirubin<85.5 mmol/L, Hepatitis B virus DNA >1×10^5copies/mL; haven't been treated with antiviral therapy within 6 months before screening.
  3. able to give written informed consent and to comply with the study protocol.
  4. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study.

Exclusion Criteria:

  1. Evidence of hepatocellular carcinoma
  2. Clinical symptoms of Decompensated liver disease at screening, including but not limited to: Serum bilirubin≥1.5 x upper limit of normal, prothrombin time of greater than 2 seconds prolonged, a serum albumin< 32g/L, or a history of ascites, variceal bleeding, or hepatic encephalopathy;
  3. Alanine transaminase>10 x upper limit of normal at screening or history of Transient hepatic decompensation caused by acute exacerbation;
  4. hemoglobin< 10g/dL, Neutrophil count<1.5 × 10^9/L, platelet count< 80 × 10^9/L;
  5. Evidence of active liver disease from other causes, including co-infection with hepatitis A virus, co-infection with hepatitis E virus, co-infection with hepatitis C virus, co-infection with hepatitis D virus, co-infection with HIV, autoimmune hepatitis (antinuclear antibody titer> 1:100);
  6. Use of immunosuppressors, immunomodulators (including interferon or thymosin) within 6 months before enrollment.
Contacts and Locations
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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): NCT02202473


Locations
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China, Jiangsu
the second hospital of Nanjing
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
Southeast University, China
Cttq
More Information
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Publications:

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Responsible Party: Wei Zhao, director of the hospital, Southeast University, China
ClinicalTrials.gov Identifier: NCT02202473    
Other Study ID Numbers: Oxymatrine
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: July 2014
Keywords provided by Wei Zhao, Southeast University, China:
Oxymatrine Capsules, lamivudine, chronic Hepatitis B
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
 DNA Virus Infections
Lamivudine
Oxymatrine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Arrhythmia Agents