Treatment of Patients With Chronic Hepatitis B With Hepatitis B Immunoglobulins (HBIG)

  • End date
    Aug 16, 2023
  • participants needed
  • sponsor
    Hannover Medical School
Updated on 16 June 2022
hepatitis b immune globulin


This is an open-label, single arm (two cohorts), single-center, phase II pilot-study to provide preliminary evidence whether hepatitis B immunoglobulins (HBIG) are efficacious and can be safely used in patients with chronic Hepatitis B Virus (HBV) infection.

A total of 20 patients (male or female adults aged ≥ 18 years) will be enrolled in the study and receive hepatitis B immunoglobulins Hepatect®CP and Zutectra®.

Condition Chronic Hepatitis B
Treatment Human hepatitis B Immunoglobulin (Hepatect®CP/Zutectra®)
Clinical Study IdentifierNCT05345990
SponsorHannover Medical School
Last Modified on16 June 2022


Yes No Not Sure

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation
in this study
Willing and able to provide written informed consent
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
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 idex (BMI) > 18kg/m²
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
progestogen-only hormonal contraception associated with inhibition of
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
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
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
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
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How to participate?

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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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