NCT06544551已完成3 期
Efficacy and Safety Study of Peginterferon Alfacon-2 to Treat Chronic Hepatitis B Virus Infection
Beijing Kawin Technology Share-Holding Co., Ltd.34 个研究点 分布在 1 个国家目标入组 336 人开始时间: 2021年12月28日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 336
- 试验地点
- 34
- 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 Alfacon-2 injection, with nucleos(t)ide (NAs), Tenofovir alafenamide Fumarate Tablets (TAF), in the patients with hepatitis B virus infection.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years (including 18 and 60), no gender limit.
- •BMI between 18 and 30 kg/m2 (including 18 and 30).
- •For treatment naive patients: Did not receive standard anti-HBV treatment within 6 months prior to screening (Including interferon, NAs, and other anti-HBV drugs).
- •For NAs treated patients: Who should have continuously taken NAs for at least 9 months prior to screening, and are currently receiving the NAs.
- •HBsAg positive for at least 6 months and HBsAg between 10 and 1000 IU/mL (excluding 10 and 1000).
- •HBsAb and HBeAg both are negative at screening.
- •For treatment naive patients: HBV DNA < 2×10^3 IU/mL at screening.
- •For NAs treated patients: HBV DNA < 100 IU/mL at screening.
- •For treatment naive patients: ALT ≤ 5ULN at screening.
- •For NAs treated patients: ALT ≤ 2ULN at screening.
- •Liver stiffness measurement <8.0 kPa at screening.
- •Pregnancy test of female of childbearing must be negative at screening, and the subjects (male and female) should take effective contraceptive measures during the whole study period.
- •Understand and sign the informed consent form voluntarily.
排除标准
- •For NAs treated patients: who have received standard treatment of interferon products within 6 months prior to screening.
- •Systemic therapy with potent immunomodulatory agents such as adrenocorticotropic hormone, thymosin α1, etc more than two weeks within past 6 months, not including corticosteroid nasal sprays, inhaled steroids and / or topical steroids.
- •Co-infected with Hepatitis A, Hepatitis C, Hepatitis D, Hepatitis E, or HIV.
- •Evidence of liver compensation, including previous liver biopsy, imaging examination or clinical manifestations.
- •Evidences of hepatic decompensation, including but not limited to serum total bilirubin> 2 times the upper limit of normal (ULN); serum albumin <35g/L; prothrombin activity (PTA) <60%; ascites, upper gastrointestinal bleeding and hepatic encephalopathy; Child-Pugh score B/C grade.
- •Evidence of hepatocellular carcinoma, or AFP>>50 ng/mL, or imaging examination revealed suspicious nodules in the liver.
- •Liver diseases from other causes, including alcoholic liver disease, non-alcoholic steatohepatitis, drug-induced hepatitis, autoimmune hepatitis (antinuclear antibody titer higher than 1:100), hepatolenticular degeneration (Wilson's disease) and hemochromatosis, etc.
- •White blood cell count <3×10^9/L; neutrophil count<1.5×10^9/L; platelet count<90×10^9/L; hemoglobin below the lower limit of normal; serum creatine kinase (CK) >3×ULN; blood phosphorus <0.8 mmol/L; serum creatinine (SCr) > 1×ULN.
- •Diabetes mellitus or Poorly controlled Thyroid Diseases.
- •Poorly controlled hypertension (systolic blood pressure> 140mmHg, or diastolic blood pressure> 90 mmHg) with hypertension -related retinal lesions.
- •Immunodeficiency or autoimmune diseases including but not limited to inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, scleroderma, Sjogren's syndrome, autoimmune thrombocytopenia, etc.
- •Psychiatric and nervous system disorders, including history of psychiatric illness or with family history (especially depression, depressive tendencies, epilepsy and hysteria, etc.)
- •Severe cardiovascular diseases (New York Heart Association functional class (NYHA) Ⅲ level and above, myocardial infarction occurred within past 6 months or PTCA performed within past 6 months, unstable angina, uncontrolled arrhythmias).
- •Serious blood disorders (all kinds of anemia, hemophilia, etc.)
- •Severe kidney disease (chronic kidney disease, renal insufficiency, etc.)
- •Serious digestive diseases (gastrointestinal ulcers, colitis, etc.)
- •Severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, interstitial lung disease, etc.)
- •Retinal disease (retinal exfoliation, macular hole, retinal tumors, etc.)
- •Malignancies.
- •Function organs transplant.
- •Allergies or severe allergies, especially allergic to study drugs or any ingredients of the study drugs.
- •Evidence of alcohol or drug abuse (average alcohol consumption male> 40g / day, female> 20g / day).
- •Women who are pregnant or lactating or to be pregnant during the study period.
- •Participated in other clinical trials 3 months prior to the screening.
- •Unwilling to sign the informed consent and adhere to treatment requirements.
- •Other conditions not suitable for study judged by investigators.
研究组 & 干预措施
Peginterferon Alfacon-2 treated patients
Experimental
干预措施: Peginterferon Alfacon-2 (Drug)
Peginterferon Alfacon-2 placebo treated patients
Placebo Comparator
干预措施: Peginterferon Alfacon-2 placebo (Drug)
结局指标
主要结局
Proportion of patients with HBsAg negative.
时间窗: 72 weeks
Percentage of Participants with HBsAg \<0.05 IU/mL
次要结局
未报告次要终点
研究者
Junqi Niu
Principal Investigator
The First Hospital of Jilin University
研究点 (34)
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