Chronic Hepatitis BPhase 2HBIGNCT05345990
Treatment of Patients With Chronic Hepatitis B With Hepatitis B Immunoglobulins
A Phase 2 study testing Human hepatitis B Immunoglobulin (Hepatect®CP/Zutectra®) in people with Chronic Hepatitis B, run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Human hepatitis B Immunoglobulin (Hepatect®CP/Zutectra®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- 15 Aug 2022to 31 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 negative.
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- 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:
- oral
- intravaginal
- transdermal
- progestogen-only hormonal contraception associated with inhibition of ovulation:
- oral
- injectable
- implantable
- Subject must be able to comply with the dosing instructions for study drug administration and be able to complete the study schedule of assessments
Who cannot join
- Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Hannover Medical School, Department for Gastroenterology, Hepatology and Endocrinology
Hanover, Lower Saxony, 30625
About this study
Official title: Hepatitis B Immunoglobulins to Induce HBsAg Clearance in Patients With Chronic Hepatitis B (HBIG for Cure)
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
- Being tested
- Human hepatitis B Immunoglobulin (Hepatect®CP/Zutectra®)
- Keywords
- Human hepatitis B Immunoglobulin
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Human hepatitis B Immunoglobulin (Hepatect®CP/Zutectra®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 12 of antiviral therapy
Secondary outcomes (6)
To analyze the change/decline of HBsAg during treatment
Secondary endpoint: HBsAg change/decline at weeks 1, 2, 4, 8 and 12 of treatment
Measured: week 1, 2, 4, 8 and 12 of treatment
To evaluate the post-treatment HBsAg kinetics/response
Secondary endpoint: Post-treatment HBsAg negativity up to FU week 24
Measured: 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
Secondary endpoint: HBV DNA levels during and after hepatitis B immunoglobulin treatment will be reported for each cohort.
Measured: 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)
Secondary endpoint: biochemical response (proportion of subjects who reached ALT normalization (ALT ≤ ULN) at week 12 of treatment)
Measured: week 12 of treatment
To determine the quality of life by SF-36 questionnaire
Secondary endpoint: quality of life during treatment and follow-up (SF-36)
Measured: day 0, day 84, FU week 12, FU week 24
Assessment of safety by collection of adverse events (AEs) as frequencies (absolute/relative).
Adverse events (AEs) will be collected throughout the study (upon first administration of the IMPs up to 24 weeks after discontinuation of therapy, FU24) and will be reported with absolute and relative frequencies along with the corresponding 95% confidence intervals
Measured: day 0, day 1, day 3, day 7, day 14, day 21, day 28, day 42, day 56, day 84, FU week 2, FU week 4, FU week 12, FU week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start15 Aug 2022
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Why it stopped: A full recruitment for the study was no longer expected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients treated in two cohorts for 12 weeks with hepatitis B immunoglobulins
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Biotest
- Responsible party
- Sponsor
- Investigators
- Heiner Wedemeyer, Prof., Principal investigator, Hannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345990
- Sponsor's protocol ID
- HBIGforcure
- Other IDs
- 2021-005362-18
- Acronym
- HBIG
- Status last verified
- Aug 2025
- First submitted
- 29 Mar 2022
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis B Immunoglobulins to Induce HBsAg Clearance in Patients With Chronic Hepatitis B (HBIG for Cure)
- ClinicalTrials.gov ID
- NCT05345990
- Acronym / sponsor ID
- HBIG / HBIGforcure
- Conditions
- Chronic Hepatitis B
- Keywords
- Human hepatitis B Immunoglobulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A full recruitment for the study was no longer expected.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Biotest
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients treated in two cohorts for 12 weeks with hepatitis B immunoglobulins
| Arm | Type | Receives |
|---|---|---|
| Hepatitis B immunoglobulins | Experimental | Drug: Human hepatitis B Immunoglobulin (Hepatect®CP/Zutectra®)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (10 listed)
- Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human hepatitis B Immunoglobulin (Hepatect®CP/Zutectra®)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 | Drug | Hepatitis B immunoglobulins |
Primary outcome
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
Time frame: week 12 of antiviral therapy
Primary efficiency endpoint: HBsAg negativity at week 12 of antiviral therapy
6 secondary outcomes
To analyze the change/decline of HBsAg during treatment
Time frame: week 1, 2, 4, 8 and 12 of treatment
To evaluate the post-treatment HBsAg kinetics/response
Time frame: 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
Time frame: 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)
Time frame: week 12 of treatment
To determine the quality of life by SF-36 questionnaire
Time frame: day 0, day 84, FU week 12, FU week 24
Assessment of safety by collection of adverse events (AEs) as frequencies (absolute/relative).
Time frame: day 0, day 1, day 3, day 7, day 14, day 21, day 28, day 42, day 56, day 84, FU week 2, FU week 4, FU week 12, FU week 24
Results and safety
The study was stopped early (reason given: A full recruitment for the study was no longer expected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heiner Wedemeyer, Prof. principal investigator
Hannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human hepatitis B Immunoglobulin (Hepatect®CP/Zutectra®) in people with Chronic Hepatitis B, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: A full recruitment for the study was no longer expected.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: week 12 of antiviral therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.