Hepatitis B Virus Associated Liver DiseasePhase 1/2NCT01421212
Pilot Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin (Boca HBVIg) Used in Combination With Lamivudine for Patients With Hepatitis B Virus (HBV) Associated Liver Disease Undergoing Liver Transplantation
A Phase 1/2 study testing Hepatitis B Immune Globulin (Boca HBVIg) in people with Hepatitis B Virus Associated Liver Disease, run by Biotest Pharmaceuticals Corporation at 11 sites in United States.
Trial summary
The purpose of this study is to find the best monthly dose schedule for the new Hepatitis Immune Globulin (Boca HBVIg, a study drug) when used in combination with an antiviral agent Lamivudine after liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B Virus Associated Liver Disease
- What is being tested?
- Hepatitis B Immune Globulin (Boca HBVIg)
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 11 sitesUnited States
- Study dates
- Nov 1999to Feb 2002
- Phase
- Phase 1/2
- 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
- Be 18 years old or greater, either male or female, of any ethnic background.
- Be positive for HBsAg. Patients may be either positive or negative for anti-HDV, HBeAg, and HBV DNA (non-PCR assay).
- Be diagnosed with HBV-induced liver disease including either:
- HBsAg positive cirrhosis, or
- HBsAg positive and presence of hepatocellular carcinoma (HCC) with no evidence of vascular invasion or extrahepatic spread, and either:
- a single tumor no larger than 5 cm in diameter, or
Show all 13Show fewer
- no more than three tumors, the largest of which is no greater than 3 cm in diameter.
- Have received at least one dose of Lamivudine 100 mgs po qd prior to transplantation.
- Fulfill UNOS minimal listing criteria.
- Have received approval for liver transplantation at the respective participating center and are listed as Status 2 or 3 and felt to be within three months of liver transplantation.
- If requiring retransplantation for primary graft nonfunction or hepatic artery thrombosis, retransplantation must take place within the first four weeks of the initial transplant with no evidence of recurrent hepatitis B.
- Be able and willing to give written informed consent. In patients with Grade 3 or 4 hepatic encephalopathy, a legal guardian must be available to provide consent. In the case of a minor, a parent or guardian must provide consent.
- If a woman of childbearing potential, have a negative serum beta HCG pregnancy test within 14 days prior to starting Lamivudine therapy and within 14 days prior to transplant and agree to practice contraception during the study (a total of 36 weeks).
Who cannot join
- Eligible patients must not:
- Require retransplantation for recurrent hepatitis B.
- Have chronic hepatitis B liver disease with a history of breakthrough infection on Lamivudine
- Have other causes of liver disease including chronic hepatitis C.
- Have HCC and do not meet Inclusion Criterion #3, or who require systemic chemotherapy.
- Be seropositive for HIV infection.
- Be using experimental devices or receiving experimental drugs.
- Be participating in any other clinical treatment trial with an investigational drug within 30 days prior to liver transplantation or plan to receive another investigational drug during this study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
The University of Michigan Health System
Ann Arbor, Michigan, 48109
The University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599
Rush-Presbyterian - St. Luke's Medical Center
Chicago, Illinois, 60612
University of Florida
Gainesville, Florida, 32610
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Jackson Memorial Hospital / University of Miami
Miami, Florida, 33136
Mount Sinai Medical Center
New York, New York, 10029
New York-Presbyterian Hospital Columbia-Presbyterian Medical Center
New York, New York, 10032
Medical College of Virginia Commenwealth University
Richmond, Virginia, 23298
Rochester Methodist Hospital
Rochester, Minnesota, 55905
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin Used in Combination With Lamivudine
The purpose of this study is to find the best monthly dose schedule for the new Hepatitis Immune Globulin (Boca HBVIg, a study drug) when used in combination with an antiviral agent Lamivudine after liver transplantation. Boca HBVIg will be given along with Lamivudine to prevent hepatitis B reinfection following liver transplantation in patients with end stage liver failure due to hepatitis B infection.
- Being tested
- Hepatitis B Immune Globulin (Boca HBVIg)
- Keywords
- Liver Transplantation, Liver Disease, Hepatitis B, Hepatitis B Infection, Hepatitis B Associated Liver Disease, HBV
- Medical subject headings
- Liver Diseases, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis B Immune Globulin (Boca HBVIg)Biological
Also called Nabi-HB, HepaGam B, Hepatitis B Immune Globulin, HBIG
Phase I (12 weeks): Intravenous Boca HBVIg 10,000 IU administered intraoperatively during the anhepatic phase, following reperfusion, daily on days 1-7, once during week 4 and once during week 8 (total of 11 doses).
Phase II (24 weeks): Starting at 12 weeks post liver transplantation, Boca HBVIg will be reduced to 5,000 IU given intravenously on a monthly basis for patients who had an anti-HBs trough titer greater than or equal to 500 IU/L at 8 weeks without the need for additional Boca HBVIg doses. Patients with an 8 week trough level less than 500 IU/L will receive 10,000 IU Boca HBVIg every 4 weeks for the remainder of the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hepatitis B virus positive liver transplant recipients with no hepatitis B virus recurrence after liver transplantation.
Number of participants who maintain a protective trough titer of anti hepatitis B antibodies beginning at 12 weeks post liver transplantation.
Secondary outcomes (1)
Change in anti hepatitis B antibodies levels with administration of Boca hepatitis B immune globulin concomitantly with Lamivudine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startNov 1999
- Primary completionFeb 2002
- Study completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B Virus Associated Liver DiseaseStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotest Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rolland C. Dickson, M.D., Principal investigator, Mayo ClinicNorah A. Terrault, M.D., MPH, Principal investigator, University of California, San Francisco, CADonald Jensen, M.D., Principal investigator, Rush-Presbyterian - St. Luke's Medical Center, Chicago, ILTerence Angtuaco, M.D., Principal investigator, Rush-Presbyterian - St. Luke's Medical Center, Chicago, ILPatricia Sheiner, M.D., Principal investigator, Mount Sinai Medical Center, New York, NYVelimir A. Luketic, M.D., Principal investigator, Virginia Commonwealth University, Richmond, VAMichael Fried, M.D., Principal investigator, University of North Carolina, Chapel Hill, NCRobert S. Brown, M.D., MPH, Principal investigator, Columbia-Presbyterian Medical Center, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421212
- Sponsor's protocol ID
- Nabi-4204
- Status last verified
- Aug 2011
- First submitted
- 18 Aug 2011
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin Used in Combination With Lamivudine
- ClinicalTrials.gov ID
- NCT01421212
- Acronym / sponsor ID
- Nabi-4204
- Keywords
- Liver Transplantation, Liver Disease, Hepatitis B, Hepatitis B Infection, Hepatitis B Associated Liver Disease, HBV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Biotest Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 1999
- Primary completion
- Feb 2002 (actual)
- Study completion
- Feb 2002 (actual)
- First posted
- 22 Aug 2011 (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 find the best monthly dose schedule for the new Hepatitis Immune Globulin (Boca HBVIg, a study drug) when used in combination with an antiviral agent Lamivudine after liver transplantation. Boca HBVIg will be given along with Lamivudine to prevent hepatitis B reinfection following liver transplantation in patients with end stage liver failure due to hepatitis B infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Be 18 years old or greater, either male or female, of any ethnic background.
- Be positive for HBsAg. Patients may be either positive or negative for anti-HDV, HBeAg, and HBV DNA (non-PCR assay).
- Be diagnosed with HBV-induced liver disease including either:
- HBsAg positive cirrhosis, or
- HBsAg positive and presence of hepatocellular carcinoma (HCC) with no evidence of vascular invasion or extrahepatic spread, and either:
Key exclusion criteria (8 listed)
- Eligible patients must not:
- Require retransplantation for recurrent hepatitis B.
- Have chronic hepatitis B liver disease with a history of breakthrough infection on Lamivudine
- Have other causes of liver disease including chronic hepatitis C.
- Have HCC and do not meet Inclusion Criterion #3, or who require systemic chemotherapy.
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 |
|---|---|---|
| Hepatitis B Immune Globulin (Boca HBVIg)Also: Nabi-HB, HepaGam B, Hepatitis B Immune Globulin, HBIGPhase I (12 weeks): Intravenous Boca HBVIg 10,000 IU administered intraoperatively during the anhepatic phase, following reperfusion, daily on days 1-7, once during week 4 and once during week 8 (total of 11 doses). Phase II (24 weeks): Starting at 12 weeks post liver transplantation, Boca HBVIg will be reduced to 5,000 IU given intravenously on a monthly basis for patients who had an anti-HBs trough titer greater than or equal to 500 IU/L at 8 weeks without the need for additional Boca HBVIg doses. Patients with an 8 week trough level less than 500 IU/L will receive 10,000 IU Boca HBVIg every 4 weeks for the remainder of the study. | Biological | – |
Primary outcome
Number of hepatitis B virus positive liver transplant recipients with no hepatitis B virus recurrence after liver transplantation.
Number of participants who maintain a protective trough titer of anti hepatitis B antibodies beginning at 12 weeks post liver transplantation.
1 secondary outcome
Change in anti hepatitis B antibodies levels with administration of Boca hepatitis B immune globulin concomitantly with Lamivudine.
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 22 Jan 2019.
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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.
Rolland C. Dickson, M.D. principal investigator
Mayo Clinic
Norah A. Terrault, M.D., MPH principal investigator
University of California, San Francisco, CA
Donald Jensen, M.D. principal investigator
Rush-Presbyterian - St. Luke's Medical Center, Chicago, IL
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hepatitis B Immune Globulin (Boca HBVIg) in people with Hepatitis B Virus Associated Liver Disease, run by Biotest Pharmaceuticals Corporation at 11 sites in United States.
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 13 inclusion and 8 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 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Number of hepatitis B virus positive liver transplant recipients with no hepatitis B virus recurrence after liver transplantation.. The study lists 2 primary outcomes in all. 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 22 Jan 2019.