EUCTR2021-005362-18-DE进行中（未招募）1 期
Hepatitis B immunoglobulins to induce HBsAg clearance in patients with chronic hepatitis B
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in
- •this study:
- •1. Willing and able to provide written informed consent
- •2. Male or female, age = 18 years
- •3. Confirmation of chronic HBV infection documented by:
- •positive HBsAg at least 12 months before screening
- •4. 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.
- •5. 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.
- •6. 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
- •7. Transient Elastography (FibroScan) < 7.5 kPa at screening.
- •8. ALT levels < 1.5 times of upper the limit of normal at screening for both cohorts
- •9. Body mass idex (BMI) > 18kg/m²
- •10. 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.
- •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:
- •- intravaginal
- •- transdermal
- •o progestogen-only hormonal contraception associated with inhibition of ovulation:
- •- injectable
- •- implantable
- •11. Subject must be able to comply with the dosing instructions for study drug administration and be able to complete the study schedule of assessments
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
- •1. 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.
- •2. 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.
- •3. Clinical hepatic decompensation (i.e. clinical ascites, encephalopathy or variceal
- •hemorrhage).
- •4. 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.
- •5. Significant drug allergy (such as anaphylaxis or hepatotoxicity).
- •6. Pregnant or nursing female or male with pregnant female partner
- •7. 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.
- •8. 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.
- •9. A recent SARS-COV2 infection in the last 4 weeks prior to screening
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