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

NCT02202473 | Completed Phase 4 DMC

• 1 other identifier: Oxymatrine
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Keywords

Oxymatrine Capsules, lamivudine, chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Hepatitis B virus resistance loci

  1, 3, 6, 12, 15, 18 months

Study Arms (2)

Lamivudine

ACTIVE COMPARATOR

Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd

Drug: Lamivudine

Lamivudine+Oxymatrine Capsules

EXPERIMENTAL

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

Drug: Lamivudine+Oxymatrine Capsules

Interventions

Lamivudine DRUG

Lamivudine

Lamivudine+Oxymatrine Capsules DRUG

Lamivudine+Oxymatrine Capsules

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to 60 years old.
• 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.
• able to give written informed consent and to comply with the study protocol.
• Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study.

You may not qualify if:

• Evidence of hepatocellular carcinoma
• 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;
• Alanine transaminase\>10 x upper limit of normal at screening or history of Transient hepatic decompensation caused by acute exacerbation;
• hemoglobin\< 10g/dL, Neutrophil count\<1.5 × 10\^9/L, platelet count\< 80 × 10\^9/L;
• 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);
• Use of immunosuppressors, immunomodulators (including interferon or thymosin) within 6 months before enrollment.

Sponsors & Collaborators

• Southeast University, China: lead
• Cttq: collaborator

Study Sites (1)

the second hospital of Nanjing

Nanjing, Jiangsu, 210000, China

Location

Related Publications (3)

• Lu FM, Zhuang H. Management of hepatitis B in China. Chin Med J (Engl). 2009 Jan 5;122(1):3-4. No abstract available.

  PMID: 19187608 BACKGROUND

• 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.

  PMID: 19324298 BACKGROUND

• 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.

  PMID: 21277330 BACKGROUND

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Lamivudine

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of the hospital

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 29, 2014
• Primary Completion: February 1, 2014
• Last Updated: July 29, 2014

Record last verified: 2014-07

Locations

CN (1)