Treatment of Patients With Chronic Hepatitis B With Hepatitis B Immunoglobulins

Launched by HANNOVER MEDICAL SCHOOL · Apr 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a treatment called hepatitis B immunoglobulins (HBIG) for patients with chronic Hepatitis B infection. The trial will enroll a total of 20 adults, both men and women, aged 18 and older, who either have been receiving a specific type of medication for at least a year or have not received any treatment for the same duration. Participants must have confirmation of their chronic Hepatitis B infection and meet certain health criteria, such as having specific levels of the virus in their blood and a healthy liver condition.

If you decide to participate, you will receive the HBIG treatment and will be monitored closely throughout the study. The trial is designed to gather early information on how well this treatment works and how safe it is for patients like you. It’s important to note that there are certain health conditions and recent medical histories that might prevent someone from joining, like other serious illnesses or recent infections. This study is currently looking for volunteers, so if you think you might be eligible and are interested, please talk to your doctor for more details.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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 longer.
• • 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. 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:
• * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
• • oral
• • intravaginal
• • transdermal
• * progestogen-only hormonal contraception associated with inhibition of ovulation:
• • oral
• • 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
• Exclusion Criteria:
• 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