NCT05827146已完成2 期
Double-blinded, Placebo-controlled, Munticenter, Phase IIa Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D
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
- 23
- 试验地点
- 3
- 主要终点
- Hepatitis D Virus(HDV) RNA level
研究概览
简要总结
A phase 2a clinical Study of Hepalatide for Injection in Subjects with Chronic Hepatitis D
详细描述
This is a four-arm parallel-group, randomized, placebo-controlled, double-blind, multicenter Phase IIa clinical trial. The CHD subjects who meet the eligibility criteria will be randomly assigned 1:1:1:1 to receive either the placebo or investigational drug (2.1 mg, 4.2 mg, or 6.3 mg), with 6 subjects per group . The placebo or the corresponding dose of the investigational drug will be given for 4 consecutive weeks, followed by a 4-week follow-up period. Subjects will be given entecavir for the treatment of hepatitis B infection during and after the end of the trial.
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
- •Male or female, 18-65 years old (both inclusive);
- •HBsAg (+) and/or HBV DNA (+) for at least 6 months (clinically diagnosed as "chronic hepatitis B");
- •HDV-antibody (IgG/IgM) (+) and HDV RNA (+);
- •1×ULN <ALT<10×ULN；
- •Patients with hepatitis B eligible to receive treatment with NAs according to current guidelines for the diagnosis and treatment of hepatitis B;
- •Patients who do not plan a pregnancy within two years (women who are not pregnant or lactating) and agree to take effective contraceptive measures throughout the treatment period and within 3 months after the last dose;
- •Patients who did not participate in any other clinical trials within 3 months;
- •Patients with good compliance with the study protocol;
- •Patients who understand and agree to sign an informed consent form.
排除标准
- •Decompensated liver disease: Direct bilirubin > 1.2× ULN, prothrombin time > 1.2× ULN, and serum albumin < 35 g/L;
- •Patients with abnormal results of routine hematology test: White blood cell count (WBC) < 3×109/L, neutrophil count < 1.5×109/L and platelet count < 60×109/L;
- •Severely decompensated hepatic fiborosis or decompensated cirrhosis: Definitely diagnosed decompensated cirrhosis by imaging examinations such as a Color Doppler ultrasound and CT of the abdomen or clinically diagnosed decompensated cirrhosis by the investigator, or a Metavir fibrosis score of 4 on a liver biopsy sample, or a Child-Pugh score > 7 for liver function assessment;
- •Patients who have any of the following conditions:
- •A history of decompensated liver disease (ascites, jaundice, hepatic encephalopathy, variceal bleeding);
- •A history of serious cardiovascular disease (including unstable or uncontrolled cardiovascular disease within 6 months);
- •Serious mental illness or a history of serious mental illness;
- •A history of organ transplantation;
- •Uncontrolled epilepsy, mental illness, or poorly controlled diabetes or hypertension;
- •Autoimmune disease, immune-related extrahepatic manifestations (vasculitis, purpura, arteritis nodosa, peripheral neuropathy, and glomerulonephritis), thyroid disease, malignant tumor, and receiving immunosuppressive therapy;
- •Underlying diseases such as severe infection, heart failure, chronic obstructive pulmonary disease, and other severe diseases;
- •A history of alcohol or drug abuse.
- •Creatinine clearance < 60 mL/min;
- •HAV/HCV/HEV/HIV co-infection;
- •Resistance to or poor response to Entecavir;
- •An allergic reaction to Entecavir;
- •Patients who have used interferon within 3 months before the screening period;
- •Previously received L47 or Bulevirtide;
- •Women who have a positive pregnancy test;
- •Patients who have other significantly abnormal results of laboratory or auxiliary tests and are unsuitable for this trial.
研究组 & 干预措施
Hepalatide 2.1mg
Experimental
2.1 mg/day subcutaneously (s.c.) for 4 week
干预措施: Hepalatide (Drug)
Hepalatide 4.2mg
Experimental
4.2 mg/day subcutaneously (s.c.) for 4 week
干预措施: Hepalatide (Drug)
Hepalatide 6.3mg
Experimental
6.3 mg/day subcutaneously (s.c.) for 4 week
干预措施: Hepalatide (Drug)
Placebo 2.1mg/4.2mg/6.3mg
Placebo Comparator
Placebo 2.1 mg/4.2mg/6.3mg, once a day subcutaneously (s.c.) for 4 week
干预措施: Hepalatide Placebo (Drug)
结局指标
主要结局
Hepatitis D Virus(HDV) RNA level
时间窗: Week 4
HDV RNA level at week4
次要结局
- Change in Alanine transaminase(ALT) from baseline(Week 4)
- Change in HDV RNA from baseline(Week 4)
研究者
研究点 (3)
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