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

Chronic Hepatitis B Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02202473
• Other study ID #: Oxymatrine
• Status: Completed
• Phase: Phase 4
• First received: July 24, 2014
• Last updated: July 24, 2014

Study information

• Verified date: July 2014
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Lamivudine

• Lamivudine+Oxymatrine Capsules

Locations

Country	Name	City	State
China	the second hospital of Nanjing	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Southeast University, China	Cttq

Country where clinical trial is conducted

China, 

References & Publications (3)

Lu FM, Zhuang H. Management of hepatitis B in China. Chin Med J (Engl). 2009 Jan 5;122(1):3-4. — View Citation

Wang YP, Zhao W, Xue R, Zhou ZX, Liu F, Han YX, Ren G, Peng ZG, Cen S, Chen HS, Li YH, Jiang JD. Oxymatrine inhibits hepatitis B infection with an advantage of overcoming drug-resistance. Antiviral Res. 2011 Mar;89(3):227-31. doi: 10.1016/j.antiviral.2011.01.005. Epub 2011 Jan 28. — View Citation

Yuen MF, Fung J, Wong DK, Lai CL. Prevention and management of drug resistance for antihepatitis B treatment. Lancet Infect Dis. 2009 Apr;9(4):256-64. doi: 10.1016/S1473-3099(09)70056-8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of Hepatitis B virus DNA titer compared to Baseline Hepatitis B virus DNA titer every 3 months for 18 months		1, 3, 6, 12, 15, 18 months	No
Secondary	Hepatitis B virus resistance loci		1, 3, 6, 12, 15, 18 months	No