Hepatitis BPhase 3NCT01513850
A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
A Phase 3 study testing Hepabulin IV in people with Hepatitis B, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Hepabulin IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2010to Mar 2014
- Phase
- Phase 3
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HBsAg Positive candidate for HBV-related liver transplant
- Primary, single organ recipients
- written informed consent
Who cannot join
- acute renal failure, Serum creatinin >1.5*ULN
- severe cardiac disease or other significant disease
- HAV, HCV or HIV positive
- Immunoglobulin A deficiency.
- History of hypersensitivity to Human Immunoglobulin.
- History of cancer within 5 years. (without HCC)
Show all 10Show fewer
- History of alcohol or/and drug abuse.
- History organ transplantation.
- Within 30 days, participation in another clinical trial and use of an investigational product.
- Subject suffer from any acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that, may increase the risk associated with the study participation or investigational product administration, or may interfere with the interpretation of study result.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 52-week, Multi-center, Open Label, Single Arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.
Read the detailed description
A 52-week, Multi-center, Open label, Single arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg positive Liver Transplantation recipients
- Conditions
- Hepatitis B
- Being tested
- Hepabulin IV
- Keywords
- Liver Transplantation, HBV, HBV Recurrence, HBsAg Positive
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepabulin IVDrug
I.V.
| Study group | Role | What they receive |
|---|---|---|
| Hepabulin IV | Experimental | Not described Receives: Drug: Hepabulin IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV(HBsAg) recurrence
Measured: 52 weeks
Secondary outcomes (3)
Time to recurrence
Measured: 52 weeks
Survival
Measured: 52 weeks
viral Marker of HBV
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startOct 2010
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong Goo Kim, MD, PhD, Study chair, St.Mary's Hospital, Catholic University Medical college
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513850
- Sponsor's protocol ID
- Hepabulin IV_LT_lll_2011
- Status last verified
- May 2015
- First submitted
- 16 Jan 2012
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-week, Multi-center, Open Label, Single Arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
- ClinicalTrials.gov ID
- NCT01513850
- Acronym / sponsor ID
- Hepabulin IV_LT_lll_2011
- Conditions
- Hepatitis B
- Keywords
- Liver Transplantation, HBV, HBV Recurrence, HBsAg Positive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 20 Jan 2012 (estimated)
- 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.
The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.
Detailed description
A 52-week, Multi-center, Open label, Single arm, Phase 3 Study to Evaluate the Efficacy and Safety of Hepabulin IV in HBsAg positive Liver Transplantation recipients
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepabulin IV | Experimental | Drug: Hepabulin IV |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- HBsAg Positive candidate for HBV-related liver transplant
- Primary, single organ recipients
- written informed consent
Key exclusion criteria (10 listed)
- acute renal failure, Serum creatinin >1.5*ULN
- severe cardiac disease or other significant disease
- HAV, HCV or HIV positive
- Immunoglobulin A deficiency.
- History of hypersensitivity to Human Immunoglobulin.
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 |
|---|---|---|
| Hepabulin IVI.V. | Drug | Hepabulin IV |
Primary outcome
HBV(HBsAg) recurrence
Time frame: 52 weeks
3 secondary outcomes
Time to recurrence
Time frame: 52 weeks
Survival
Time frame: 52 weeks
viral Marker of HBV
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
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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.
Dong Goo Kim, MD, PhD study chair
St.Mary's Hospital, Catholic University Medical college
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hepabulin IV in people with Hepatitis B, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
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 3 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: finished, as of the sponsor's last update on 1 Jun 2015. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HBV(HBsAg) recurrence (time frame: 52 weeks). 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 1 Jun 2015; AzTrials last refreshed its copy on 8 Nov 2026.