NCT00140725已完成3 期
A Randomised Trial of Lamivudine Plus Interferon Versus Lamivudine for the Treatment of HBeAg Positive Chronic Hepatitis B Virus (HBV)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Proportion of patients with HBeAg seroconversion to anti-HBe
研究概览
简要总结
This is a single-centre prospective randomised study comparing the virological and histological response of HBV infection to lamivudine in combination with interferon versus lamivudine alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Untreated chronic hepatitis B patients with evidence of HBV replication as documented by serum HNV-DNA positive within 3 months prior to entry and serum HBeAg positive at screening.
- •Documented presence of abnormal alanine aminotransferase (ALT) (1.3 - 5X upper limit normal (ULN)) within 1 month prior to entry and signs of compensated liver disease.
排除标准
- •Patients with any cause for liver disease other than chronic hepatitis B and evidence or history of decompensated liver disease.
结局指标
主要结局
Proportion of patients with HBeAg seroconversion to anti-HBe
次要结局
- Normalization of alanine aminotransferase (ALT)
- Undetectable HBV DNA
- Histologic improvement
- Tyrosine, methionine, aspartate, aspartate (YMDD) mutants among the viremic relapsers at the end of therapy and safety of treatment
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Treatment of HIV/HCV Coinfection With Peg-IFN and Ribavirin in Patients Receiving ART Monotherapy With Lopinavir/rHIV/HCV Co-infectionHIV InfectionsNCT00866021Fundacion SEIMC-GESIDA68
已完成
3 期
Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment-NaiveChronic Hepatitis CNCT00230958Bausch Health Americas, Inc.900
已完成
2 期
A Randomized Trial to Evaluate the Safety and Efficacy of Combination Therapy With Retrovir ( AZT ) and HIVID ( ddC ) Versus Retrovir, HIVID, and Wellferon ( Interferon Alfa-n1 ) for the Treatment of HIV InfectionHIV InfectionsNCT00002086Glaxo Wellcome256
已完成
3 期
Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment NaiveChronic Hepatitis CNCT00093093Bausch Health Americas, Inc.900
终止
2 期
Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyUlcerative ColitisNCT00279435Facet Biotech25