Using hepatitis B immunoglobulins to treat chronic hepatitis B

Hepatitis B Immunoglobulins to Induce HBsAg Clearance in Patients With Chronic Hepatitis B (HBIG for Cure)

This study is testing if hepatitis B immunoglobulins can help adults with chronic hepatitis B feel better and improve their health.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hannover Medical School (Academic / other)
• Locations: 1 site (Hannover, Lower Saxony)
• Trial ID: NCT05345990 on ClinicalTrials.gov

What this trial studies

This is an open-label, single-arm pilot study aimed at evaluating the efficacy and safety of hepatitis B immunoglobulins (HBIG) in patients with chronic Hepatitis B Virus (HBV) infection. A total of 20 adult patients will be enrolled and divided into two cohorts based on their previous treatment history. Participants will receive either Hepatect®CP or Zutectra® as part of the intervention. The study will assess the impact of these immunoglobulins on HBV infection markers and overall patient health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed chronic HBV infection and specific viral load criteria.

Not a fit: Patients who have not been diagnosed with chronic hepatitis B or those with advanced liver disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from chronic hepatitis B.

How similar studies have performed: While this approach is being explored in this pilot study, similar studies have shown promise in using immunoglobulins for viral infections, but this specific application is novel.

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

Where this trial is running

Hannover, Lower Saxony

• Hannover Medical School, Department for Gastroenterology, Hepatology and Endocrinology — Hannover, Lower Saxony, Germany (Recruiting)

Study contacts

• Principal investigator: Heiner Wedemeyer, Prof. — Hannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology
• Study coordinator: Katja Deterding, Dr.

Conditions Chronic Hepatitis B; Human hepatitis B Immunoglobulin