NCT02332473已完成2 期
A Prospective Phase 2 Clinical Trial to Assess the Efficacy and Safety of Combination of Peginterferon Alfa-2b (40kD, Y-shape) and GM-CSF in Chronic Hepatitis Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 12
- 主要终点
- Percentage of HBeAg seroconversion at the end of treatment
研究概览
简要总结
This study is a multi-center, randomized, prospective open-label study to assess the efficacy and safety of combination of peginterferon alfa-2b (40kD, Y-shape) and GM-CSF in interferon-naïve chronic hepatitis B patients with HBeAg positive. Patients were randomized to one of the 2 groups to receive different antiviral treatment.
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
- •18yrs≤age≤65yrs.
- •17≤BMI(body mass index)≤
- •HBsAg positive≥6 months.
- •Serum HBV DNA≥20,000IU/ml, HBsAg positive and HBeAg positive at screening.
- •2ULN≤ALT≤10ULN(ULN=upper limit of normal) at screening.
- •Pregnancy test must be negative for female patients of childbearing potential. All patients take effective birth control measures during treatment and 6 months after the treatment.
- •Agree to participate in the study and sign the informed consent.
排除标准
- •Pregnant or lactating females
- •Interferon treatment history, or using nucleos(t)ide analogues for chronic hepatitis B treatment within the previous 6 months, or any evidence of nucleosi(t)ide analogues resistance .
- •Receiving strong immunomodulatory agents (e.g., steroids, thymosin) for more than two weeks 6 months prior to screening.
- •Receiving hepatotoxicity agents (e.g., aczone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than two weeks 6 months prior to screening.
- •Co-infected with active hepatitis A, hepatitis C, hepatitis D, and/or human immunodeficiency virus (HIV).
- •History or evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., autoimmune hepatitis, alcoholic liver disease, toxin exposures.
- •Suffering from any other acute or chronic infectious disease.
- •Mental disorder or physical disability, or family history of neurological and psychiatric disorders.
- •Neutrophil count <1500 cells/mm3, or platelet count <90000 cells/mm3 at screening.
- •Child-Pugh≥B, or other evidence of liver decompensation (e.g. serum albumin<35g/L , prothrombin time>3 seconds prolonged, serum bilirubin>2ULN, prothrombin activity <60%, history of liver decompensation).
- •Serum creatinine level >ULN in screening period.
- •Serum creatine kinase level >2ULN except for physiological factors (e.g., exercise).
- •AFP>100ng/L. If 50ng/L<AFP<100ng/L at screening, retest 2 weeks later, and if AFP <50ng/L can enrolled, vs, excluded.
- •Hepatocarcinoma or suffering from any other malignant tumor.
- •Autoimmune disease(e.g., psoriasis, systemic lupus erythematosus).
- •Moderate or severe hypertension, or mild hypertension without well controlled.
- •With not well- controlled endocrine disease (e.g., thyroid dysfunction, diabetes mellitus).
- •Drug abusing, or alcoholism.
- •HBeAb positive or HBsAb positive at screening.
- •Allergic to interferon, or GM-CSF, or any fragment of the study drug.
- •Other conditions which in the opinion of the investigator precluding enrollment into the study(e.g., low compliance).
研究组 & 干预措施
Arm A
Active Comparator
Ypeginterferon alfa-2b,sc. Qw. 48 weeks.
干预措施: Ypeginterferon alfa-2b (Drug)
Arm B
Experimental
Ypeginterferon alfa-2b,sc. Qw. 48 weeks. Granulocyte-macrophage colony stimulating factor,sc.qd, the first three day of every 28 days, starting from interferon treatment week 13.
干预措施: Ypeginterferon alfa-2b (Drug)
Arm B
Experimental
Ypeginterferon alfa-2b,sc. Qw. 48 weeks. Granulocyte-macrophage colony stimulating factor,sc.qd, the first three day of every 28 days, starting from interferon treatment week 13.
干预措施: Granulocyte-macrophage colony stimulating factor (Drug)
结局指标
主要结局
Percentage of HBeAg seroconversion at the end of treatment
时间窗: week 48
次要结局
- Change of HBV DNA from baseline and percentage of HBV DNA undetectable at week 12, 24, 36, and 48(treatment week 12, 24, 36, and 48)
- Percentage of ALT normalization at week 24, 36 and 48(week 24 ,36 and 48)
- Change of HBsAg and HBeAg from baseline at week 12, 24, 36, and 48(week 12, 24, 36, and 48)
- Percentage of HBsAg undetectable and seroconversion at the end of treatment(week 48)
- Percentage of HBeAg undetectable and seroconversion at week 12, 24, 36 and 48(week 12, 24, 36 and 48)
研究者
研究点 (12)
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