2024-513792-41-00招募中2 期
Hepatitis B immunoglobulins to induce HBsAg clearance in patients with chronic hepatitis B (HBIG for cure)
Medizinische Hochschule Hannover1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年11月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- HBsAg negativity at week 12 of antiviral therapy
研究概览
简要总结
To evaluate the efficacy of 12-weeks treatment with hepatitis B immunoglobulins in two different cohorts of patients with chronic hepatitis B defined by the proportion of subjects being HBsAg negative at treatment week 12
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent
- •A negative serum pregnancy test is required for female subjects (unless surgically sterile or women > 54 years of age with cessation for > 24 months of previously occurring menses). Complete abstinence from intercourse. Periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation methods) is not permitted. Or: Consistent and correct use of 1 of the following methods of birth control listed below, in addition to a male partner who correctly uses a condom, from the date of Screening until the end of FU: •intrauterine device (IUD) with a failure rate of < 1% per year •bilateral tubal sterilization •vasectomy in male partner •hormone-containing contraceptive: o combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral intravaginal transdermal o progestogen-only hormonal contraception associated with inhibition of ovulation: oral injectable implantable
- •Subject must be able to comply with the dosing instructions for study drug administration and be able to complete the study schedule of assessments
- •Male or female, age ≥ 18 years
- •Confirmation of chronic HBV infection documented by: positive HBsAg at least 12 months before screening
- •Cohort A: NA treatment for at least 12 months before screening. HBV-DNA should be below the lower limit of detection at screening. HBsAg positive and <100 IU/ml. HBeAg negative.
- •Cohort B: Untreated with NAs for at least 12 months before screening. HBV-DNA < 2000 IU/ml. HBsAg positive and < 100 IU/ml. HBeAg-negative.
- •Subject has not been treated with any investigational drug or device within 42 days before the screening visit or within 5 half-lives for investigational drugs, whichever is longer.
- •Transient Elastography (FibroScan) < 7.5 kPa at screening.
- •ALT levels < 1.5 times of upper the limit of normal at screening for both cohorts
- •Body mass index (BMI) > 18kg/m²
排除标准
- •Clinically significant illness (other than hepatitis B) or any other major medical disorder that, in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol. Subjects currently under evaluation for a potentially clinically significant illness (other than hepatitis B) are also excluded.
- •Co-infection with hepatitis C virus (defined as HCV RNA positive. HCV RNA negative/anti-HCV-positive patients can be included) or co-infection with HIV.
- •Clinical hepatic decompensation (i.e. clinical ascites, encephalopathy or variceal hemorrhage).
- •Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 2 years. Subjects with psychiatric illness that is well-controlled on a stable treatment regimen for at least 12 months prior to screening or has not required medication in the last 12 months may be included.
- •Significant drug allergy (such as anaphylaxis or hepatotoxicity).
- •Pregnant or nursing female or male with pregnant female partner
- •Clinically relevant drug or alcohol abuse within 12 months of screening including any uncontrolled drug use within 6 months of screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication. The investigator must approve medication, the diagnosis and prescription. Uncontrolled users of intravenous drugs will not be permitted to enroll in the study.
- •Live-attenuated virus vaccinations such as: measles, mumps, rubella and varicella 4 weeks before and up to three months after administration of hepatitis B immunoglobulins. If not required by an emergency situation, passive or active immunizations or administration of plasma preparations or of other immunoglobulins is not allowed during the study.
- •A recent SARS-COV2 infection in the last 4 weeks prior to screening
结局指标
主要结局
HBsAg negativity at week 12 of antiviral therapy
HBsAg negativity at week 12 of antiviral therapy
次要结局
- quality of life during treatment and follow-up (SF-36)
- HBsAg decline at weeks 1, 2, 4, 8 and 12 of treatment
- post-treatment HBsAg negativity up to FU week 24
- HBV DNA levels during and after hepatitis B immunoglobulin treatment will be reported for each cohort
- biochemical response (proportion of subjects who reached ALT normalization (ALT ≤ ULN) at week 12 of treatment)
研究者
Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology - Clinical trials
Scientific
Medizinische Hochschule Hannover
研究点 (1)
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