Hepatitis B immunoglobulins to induce HBsAg clearance in patients with chronic hepatitis B

Phase 1

• Conditions: HBeAg negative patients with chronic HBV infection will be allocated into two different cohorts, cohort A and cohort B.; MedDRA version: 21.0Level: PTClassification code 10052297Term: Hepatitis B e antigen negativeSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-005362-18-DE
• Lead Sponsor: Hannover Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-29
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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:
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
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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified