NCT04846491已完成3 期
A Multi-center, Randomized, Blinded Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b Injection Combined With Tenofovir Disoproxil Fumarate Tablets in Patients With Chronic Hepatitis B
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 475
- 试验地点
- 33
- 主要终点
- Proportion of patients with HBsAg negative.
研究概览
简要总结
Current clinical practices has shown promising prospects of the therapy strategy of interferon combined with nucleos(t)ides in patients with chronic hepatitis B, but the safety and efficacy has not been fully studied. This study is aimed to exploit the safety and efficacy of the study drug, Peginterferon alfa-2b injection, with nucleos(t)ide (NAs), tenofovir disoproxil fumarate tablets (TDF), in the patients with hepatitis B, who has previously treated with nucleos(t)ides and who are treatment naïve.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Understand and sign the informed consent form voluntarily.
- •Age between 18 and 65 years (including 18 and 65), no gender limit.
- •HBsAg-positive for at least 6 months or other evidence supporting chronic infection with hepatitis B virus.
- •HBsAg positive at screening.
- •For NAs treated patients: Who should have continuously taken NAs for at least 9 months prior to screening, and are currently receiving the NAs. Simultaneously, the patients should have achieved the following criteria: HBsAg<1500IU/mL, HBV DNA<100IU/ml, HBeAg<10s/co at screening.
- •For treatment naive patients: HBV DNA≥1×10^4IU/ml, and 2×ULN (upper limit of normal) ≤ALT≤10×ULN at screening.
- •Pregnancy test of female of childbearing must be negative within 24 hours before the first medication, and the subjects (male and female) should take effective contraceptive measures during the whole study period.
排除标准
- •Women who are pregnant, breastfeeding or planning to pregnant during the study period.
- •Subjects with neuropsychiatric diseases and/or neuropsychiatric family history, especially depression, anxiety, or mania schizophrenia.
- •Co-infected with Hepatitis A, Hepatitis C, Hepatitis D, Hepatitis E, or HIV.
- •Chronic hepatitis other than hepatitis B, e.g. alcoholic hepatitis, drugs-induced hepatitis, or autoimmune hepatitis, etc.
- •Moderate to severe steatohepatitis.
- •Evidence of acute severe hepatitis, e.g. ALT>10×ULN, significantly increasing in ALT accompanied by elevated bilirubin, etc.
- •Evidence of liver decompensation, e.g. total bilirubin higher than 2×ULN, albumin lower than 35g/L, prothrombin time is 3 seconds longer than the upper limit of normal, prothrombin activity lower than 60%, or history of decompensated liver cirrhosis, etc.
- •Evidence of hepatocellular carcinoma, or AFP>1×ULN.
- •Significant kidney diseases, including acute nephritis, chronic nephritis, renal insufficiency, nephrotic syndrome, etc. or serum creatinine higher than upper limit of normal.
- •Neutrophil count less than 1.5×10^9/L, or platelet count less than 90×10^9/L at screening.
- •Serum phosphorus lower than 0.8mmol/L.
- •Antinuclear antibody (ANA) exceeds 1:
- •Autoimmune disease, including psoriasis, systemic lupus erythematosus, etc.
- •Subjects with endocrine system disease, including thyroid, Diabetes mellitus, etc.
- •Poorly controlled hypertension (blood pressure ≥140/90 mmHg).
- •Subjects with severe heart disease, especially those with unstable angina or poorly controlled heart disease within 6 months prior to screening.
- •Severe retinopathy or any other severe diseases in the eyes.
- •Subject who had ever received organ transplants or are planning to receive organ transplant.
- •For NAs-treated patients: who have received standard treatment of interferon products within 6 months prior to screening .
- •For treatment naive patients: who have ever received standard treatment of interferon products, or who have ever received NAs within 6 months prior to screening.
- •Subject who are allergic to interferon, tenofovir, or any excipients, or meet any of the contraindications described in the drug instructions.
- •Subjects who participated in any other interventional trials within 3 months prior to screening, or with any other conditions which in the opinion of the investigator precluding enrollment from the study.
研究组 & 干预措施
Nucleot(s)ide-treated patients-Experimental Group 1
Experimental
干预措施: Peginterferon alfa-2b injection (Drug)
Nucleot(s)ide-treated patients-Experimental Group 2
Experimental
干预措施: Peginterferon alfa-2b injection (Drug)
Nucleot(s)ide-treated patients-Control Group
Active Comparator
干预措施: TDF (Drug)
Treatment Naive Group
Other
干预措施: Peginterferon alfa-2b injection (Drug)
结局指标
主要结局
Proportion of patients with HBsAg negative.
时间窗: 24 weeks post treatment.
次要结局
- Changes of HBsAg level from baseline.(up to 168 weeks.)
- Proportion of patients with HBsAg seroconversion.(up to 168 weeks.)
- Proportion of patients with HBeAg negative.(up to 168 weeks)
- Proportion of patients with HBeAg seroconversion.(up to 168 weeks.)
- Changes of HBeAg level from baseline.(up to 168 weeks.)
- Proportion of patients with HBV DNA undetectable.(up to 168 weeks.)
- Changes of HBV DNA level from baseline.(up to 168 weeks.)
- Proportion of patients with ALT normalization.(up to 168 weeks.)
- Proportion of patients with liver fibrosis.(up to 168 weeks.)
- Proportion of patients with liver cirrhosis.(up to 168 weeks.)
研究者
研究点 (33)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety Study of Peginterferon Alfacon-2 to Treat Chronic Hepatitis B Virus InfectionChronic Hepatitis B Virus InfectionNCT06544551Beijing Kawin Technology Share-Holding Co., Ltd.336
已完成
2 期
Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C InfectionHepatitis C, ChronicNCT01435044Gilead Sciences239
已完成
4 期
A Study of Combination Treatment With Peginterferon Alfa-2a (Pegasys) Plus Ribavirin (Copegus) in Participants With Chronic Hepatitis CHepatitis C, ChronicNCT00800748Hoffmann-La Roche372
已完成
2 期
Peginterferon Alpha-2a and Ribavirin to Treat Hepatitis C in HIV-infected PatientsHepatitis CHIV InfectionsNCT00085917National Institute of Allergy and Infectious Diseases (NIAID)29
已完成
4 期
Combination Therapy With Interferon Plus Interleukin 2 and Hepatitis B Vaccine in Chronic Hepatitis B PatientsHepatitis B, ChronicNCT02360592Tongji Hospital94