Treatment of Patients With Chronic Hepatitis B With Hepatitis B Immunoglobulins

NCT05345990 | Terminated Phase 2 DMC

• 2 other identifiers: HBIGforcure2021-005362-18
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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®.

Conditions

Chronic Hepatitis B

Keywords

Human hepatitis B Immunoglobulin

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of 12-weeks treatment with hepatitis B immunoglobulins in two different cohorts of patients with chronic hepatitis B defined by the proportion of subjects being HBsAg negative at treatment week 12

  Primary efficiency endpoint: HBsAg negativity at week 12 of antiviral therapy

  week 12 of antiviral therapy

Secondary Outcomes (6)

• To analyze the change/decline of HBsAg during treatment

  week 1, 2, 4, 8 and 12 of treatment

• To evaluate the post-treatment HBsAg kinetics/response

  Follow-up (FU) week 2, FU week 4, FU week 12 and FU week 24

• To determine HBV-DNA levels during and after treatment with hepatitis B immunoglobulins

  screening, day 0, day 1, day 3, day 7, day 28, day 42, day 84, FU week 12 and FU week 24

• To evaluate the biochemical disease activity (normalization of serum ALT levels)

  week 12 of treatment

• To determine the quality of life by SF-36 questionnaire

  day 0, day 84, FU week 12, FU week 24

Study Arms (1)

Hepatitis B immunoglobulins

EXPERIMENTAL

20 patients treated in two cohorts for 12 weeks with hepatitis B Immunoglobulins (HBIG, Hepatect®CP/ Zutectra®). Cohort A: 10 HBsAg positive, HBeAg-negative patients being treated with anti-HBV nucleotide or nucleoside analogous (NAs) for at least 12 months before screening. HBV-DNA should be below the lower limit of detection at screening. HBsAg should be positive and below 100 IU/ml. Cohort B: 10 HBsAg positive, HBeAg-negative patients untreated with NAs for at least 12 months before screening. Patients with HBV-DNA levels below 2000 IU/ml and ALT \< 1.5 times upper the limit of normal. HBsAg should be positive and below 100 IU/ml. Trial duration: A recruiting period of approximately 6 months is planned. The total time per patient to complete all study visits is approximately 40 weeks including: * an 28 day screening period * an 12 week treatment period * an 24 week follow-up period

Drug: Human hepatitis B Immunoglobulin (Hepatect®CP/Zutectra®)

Interventions

Human hepatitis B Immunoglobulin (Hepatect®CP/Zutectra®) DRUG

Hepatect® is a solution to be administered Intravenously. Zutectra® is a solution to be administered subcutaneously. Treatment for 12 weeks with hepatitis B immunoglobulins with following administration scheme: D0: 10.000 IU Hepatect® i.v. D1-6: 500 IU Zutectra® s.c. D7: 10.000 IU Hepatect® i.v. D9- D84: 500 IU Zutectra® s.c. every 2nd day

Hepatitis B immunoglobulins

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 negative.
• 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:

You may not qualify if:

• 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 hemorrhage).
• 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.
• 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

Sponsors & Collaborators

• Hannover Medical School: lead
• Biotest: collaborator

Study Sites (1)

Hannover Medical School, Department for Gastroenterology, Hepatology and Endocrinology

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

hepatitis B hyperimmune globulin

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Heiner Wedemeyer, Prof.

  Hannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients treated in two cohorts for 12 weeks with hepatitis B immunoglobulins

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 26, 2022
• Study Start: August 15, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)