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Clinical Trials/EUCTR2021-005362-18-DE
EUCTR2021-005362-18-DEActive, not recruitingPhase 1

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

Hannover Medical School0 sites20 target enrollmentStarted: November 29, 2021Last updated:
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Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
20
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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
  • •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

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

Investigators

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