CLINICAL TRIALS PROFILE FOR HEPATITIS B IMMUNE GLOBULIN INTRAVENOUS (HUMAN)

All Clinical Trials for hepatitis b immune globulin intravenous (human)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00031291 ↗	Plasmapheresis of Anthrax-Vaccinated Subjects for Production of Anthrax Immune Globulin	Completed	National Institutes of Health Clinical Center (CC)		2002-02-01	This protocol is a joint project of the National Institutes of Health, the Centers for Disease Control and the United States Army Medical Research Institute for Infectious Diseases. It is designed to collect plasma from healthy employees of the Department of Defense who have been vaccinated against anthrax. The collected plasma will be pooled to make an anthrax-fighting antibody solution called anthrax immune globulin intravenous (AIGIV). This solution will be used for: - Animal experiments to test its effectiveness in preventing the development of anthrax after inhalation exposure; - Treating people severely ill with anthrax who are not improving with standard antibiotic therapy; and - Treating people exposed to spores of the bacteria that cause anthrax to try to prevent development of the disease. Healthy volunteers between 18 and 65 years of age who have received at least four doses of the anthrax vaccine and who meet the criteria for blood donors may be eligible to participate in this study. Volunteers will be recruited from Department of Defense civilian and military employees. Candidates will be screened with an interview and blood tests. Participants will undergo the following procedures: - Have a health history screen for donating plasma - Measurement of heart rate, blood pressure and temperature - Fingerstick to check hemoglobin level - Blood tests for HIV, hepatitis B and C, syphilis and other infectious diseases - Blood test for anthrax antibody levels - Plasmapheresis to collect blood plasma (the liquid part of the blood) In plasmapheresis, whole blood is drawn through a needle placed in an arm vein. The blood flows into a cell separator machine, where it is spun to separate the plasma from the blood cells. The plasma is collected in a plastic bag in the machine, while the rest of the blood is returned to the donor through the needle in the arm. During the procedure, the donor is given a blood thinner called citrate to prevent the blood from clotting while it is in the cell separator machine. The procedure lasts from 60 to 90 minutes. Only a small fraction of the body's total plasma is removed, and it is quickly replaced by the body with no long-term health effects. Participants may be requested to donate plasma as often as every 3 to 4 days or as infrequently as once a month for a maximum of six donations.
NCT00059267 ↗	Prevention of Recurrent Hepatitis B After Liver Transplantation	Completed	University of Michigan		2001-03-01	Hepatitis B accounts for approximately 5000 deaths per year in the United States. Liver transplantation offers the only hope for patients who develop end-stage liver disease. Early results of liver transplantation for hepatitis B were poor with recurrence rate of 80% and 1-year survival of only 50%. Recent studies found that preventive therapy using hepatitis B immune globulin (HBIG) or antiviral medications such as lamivudine can reduce the recurrence rate to roughly 30% with accompanying improvement in survival. However, HBIG when given as intravenous infusion in high doses is very expensive, while long-term use of lamivudine is associated with drug resistance. Some studies found that preventive therapy using both HBIG and lamivudine may decrease recurrence rate to less than 10% but the dose and duration of HBIG needed when used in combination with lamivudine is not clear. Adefovir, a new antiviral medication, is effective against lamivudine resistant hepatitis B but its role in liver transplantation is uncertain because of the risk of kidney damage. Many studies showed that the risk of recurrent hepatitis B is related to the viral load before transplant. Thus, it may be possible to tailor the preventive therapy according to the risk. The aim of this study is to establish the most cost-effective preventive therapy for recurrent hepatitis B after liver transplantation.
NCT00059267 ↗	Prevention of Recurrent Hepatitis B After Liver Transplantation	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)		2001-03-01	Hepatitis B accounts for approximately 5000 deaths per year in the United States. Liver transplantation offers the only hope for patients who develop end-stage liver disease. Early results of liver transplantation for hepatitis B were poor with recurrence rate of 80% and 1-year survival of only 50%. Recent studies found that preventive therapy using hepatitis B immune globulin (HBIG) or antiviral medications such as lamivudine can reduce the recurrence rate to roughly 30% with accompanying improvement in survival. However, HBIG when given as intravenous infusion in high doses is very expensive, while long-term use of lamivudine is associated with drug resistance. Some studies found that preventive therapy using both HBIG and lamivudine may decrease recurrence rate to less than 10% but the dose and duration of HBIG needed when used in combination with lamivudine is not clear. Adefovir, a new antiviral medication, is effective against lamivudine resistant hepatitis B but its role in liver transplantation is uncertain because of the risk of kidney damage. Many studies showed that the risk of recurrent hepatitis B is related to the viral load before transplant. Thus, it may be possible to tailor the preventive therapy according to the risk. The aim of this study is to establish the most cost-effective preventive therapy for recurrent hepatitis B after liver transplantation.
NCT01856205 ↗	Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis	Completed	B.P. Koirala Institute of Health Sciences	Phase 2	2009-05-01	Japanese encephalitis is caused by a viral infection of the brain transmitted by the bite of an infected mosquito. Patients with Japanese encephalitis can rapidly develop worsening conscious level and seizures. Around a third will die from the infection and half of survivors have serious long-term neurological disability. The majority of those affected are children. There are many causes of viral encephalitis, however Japanese encephalitis virus is the most common cause worldwide with over 60,000 cases annually. It occurs over much of Asia and the geographical range is expanding. There is no specific treatment for Japanese encephalitis virus, although several have been trialed. In this study we examined the effect of a new treatment, called intravenous immunoglobulin, on children with Japanese encephalitis in Nepal. Prior studies have suggested intravenous immunoglobulin may neutralize Japanese encephalitis virus and suppress damaging inflammation in the brain. It has previously been used in individual cases but never examined in a randomized trial. There was recently a trial of IVIG in West Nile encephalitis in the United States, in which Professor Solomon was on the Scientific Advisory Committee. In this study we will look if intravenous immunoglobulin is safe in this context, and that this treatment may alter the way the immune system manages the infection. Therefore, in this pilot study we will test the hypothesis that IVIG can be safely given to children with suspected JE, with no increased risk of serious adverse events compared with placebo. The aim of this proposal is to conduct a pilot safety and tolerability randomized placebo controlled trial of intravenous immunoglobulin (IVIG) in patients with Japanese encephalitis, to explore the relationship between JEV viral load, pro-inflammatory markers called cytokines and blood brain barrier markers, and the effect of IVIG on these relationships.

Clinical Trial Conditions for hepatitis b immune globulin intravenous (human)

Condition Name

Condition Name for hepatitis b immune globulin intravenous (human)
Intervention	Trials
Hepatitis B	3
Anthrax	1
Cirrhosis	1
Hepatocellular Carcinoma	1

Condition MeSH

Condition MeSH for hepatitis b immune globulin intravenous (human)
Intervention	Trials
Hepatitis B	3
Hepatitis A	2
Hepatitis	2
Anthrax	1

Clinical Trial Locations for hepatitis b immune globulin intravenous (human)

Trials by Country

Trials by Country for hepatitis b immune globulin intravenous (human)
Location	Trials
United States	2
Nepal	2
Denmark	1
China	1

Trials by US State

Trials by US State for hepatitis b immune globulin intravenous (human)
Location	Trials
Michigan	1
Maryland	1

Clinical Trial Progress for hepatitis b immune globulin intravenous (human)

Clinical Trial Phase

Clinical Trial Phase for hepatitis b immune globulin intravenous (human)
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for hepatitis b immune globulin intravenous (human)
Clinical Trial Phase	Trials
Completed	3
Not yet recruiting	1
RECRUITING	1

Clinical Trial Sponsors for hepatitis b immune globulin intravenous (human)

Sponsor Name

Sponsor Name for hepatitis b immune globulin intravenous (human)
Sponsor	Trials
National Institutes of Health Clinical Center (CC)	1
University of Michigan	1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1

Sponsor Type

Sponsor Type for hepatitis b immune globulin intravenous (human)
Sponsor	Trials
Other	8
NIH	2

Last updated: May 25, 2026

Hepatitis B Immune Globulin Intravenous (Human) Clinical Trials Update, Market Analysis, and Forecast for 2026-2036

Executive summary: Hepatitis B immune globulin intravenous (human) (HBIG-IV) is a niche, procurement-led product used for post-exposure prophylaxis, and for preventing recurrent hepatitis B in settings such as liver transplantation. The market is constrained by (1) long-standing availability of alternative prophylaxis pathways that reduce HBIG use in certain low-risk settings, (2) fixed-duration prophylaxis protocols rather than chronic dosing, and (3) regulatory and manufacturing continuity risks typical for plasma-derived biologics. Near-term demand is driven by transplant volume, ongoing occupational and healthcare exposure management, and the degree of adoption of prophylaxis protocols that pair HBIG with hepatitis B vaccination and/or antivirals. Commercial upside is limited unless protocols shift toward higher HBIG utilization, new indications expand eligible populations, or supply expands for lower-cost procurement contracts.

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What is hepatitis B immune globulin intravenous (human) used for, and where does demand come from?

Featured snippet answer: HBIG-IV is used to prevent hepatitis B virus (HBV) infection after exposure and to prevent HBV recurrence in high-risk clinical settings, including liver transplantation and patients receiving immunosuppressive therapy under defined protocols.

Core indications that drive utilization

HBIG-IV is typically used in controlled, time-bounded regimens, including:

• Post-exposure prophylaxis (PEP): Healthcare worker or household exposure scenarios where the source is hepatitis B surface antigen (HBsAg) positive or of unknown status, aligned with HBV exposure management guidelines.
• Liver transplantation prophylaxis: Preventing HBV recurrence after transplant in patients with HBV-related liver disease.
• Immunoprophylaxis in special populations: Certain immunosuppressive regimens where vaccination alone is insufficient.

Dosing patterns that limit market size

Unlike chronic antivirals, HBIG-IV is used in finite courses with protocol-defined stop points. Even in transplant settings, HBIG exposure is often optimized through combination strategies that may reduce HBIG duration in some modern protocols.

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What is the Orange Book status of hepatitis B immune globulin intravenous (human), and are generic or biosimilar products possible?

No complete, actionable product-level Orange Book listing can be provided here because HBIG-IV is a plasma-derived biological where exclusivity and market authorization status are typically governed under the biologics framework rather than small-molecule ANDA-style Orange Book listings. An Orange Book “H-B” style analysis requires the specific US product name(s) and National Drug Code entries. With no product identifier, a reliable status mapping cannot be produced.

Biosimilar vs generic feasibility

HBIG-IV is not a conventional “generic biologic” analog:

• Product equivalence hinges on plasma sourcing, manufacturing platform, viral inactivation/clearance performance, and potency assays.
• Substitutes may exist as differently sourced or differently manufactured immunoglobulin products, but “biosimilar” designation does not map cleanly without a defined reference product and approved pathway data.

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Which clinical trials are ongoing for hepatitis B immune globulin intravenous (human), and what endpoints matter?

No complete clinical-trial update can be produced without the specific US-licensed HBIG-IV product(s) and their developer/manufacturer, because multiple HBIG-IV products exist globally with different labeling and trial histories. A trial update must anchor to identifiable trial registries and submission-linked developers. Without a product identifier, a complete and accurate “ongoing trials and endpoints” inventory cannot be constructed.

What endpoints would typically be used

Where HBIG-IV trials exist, the endpoints generally include:

• HBsAg seroprotection and viral markers (HBV DNA suppression or absence of serologic evidence of infection)
• Post-exposure infection incidence
• HBV recurrence rates post-transplant
• Safety including infusion reactions, thromboembolic events, and immunoglobulin-related adverse events

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When do hepatitis B immune globulin intravenous (human) exclusivities expire, and what timing affects supply?

A definitive exclusivity timeline cannot be produced without identifying the specific licensed product(s) and their reference biologics in the US. HBIG-IV products typically have:

• Biologics license application (BLA) exclusivity components (which vary by product category and approval pathway).
• Patent estates (composition-of-matter, process, formulation, viral inactivation and purification methods, and clinical protocols). A product-level expiration schedule must cite each patent number and each BLA exclusivity date.

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What patents protect hepatitis B immune globulin intravenous (human), and how broad is the patent estate?

A complete patent estate summary cannot be provided because patent coverage depends on:

• the specific licensed HBIG-IV product(s),
• the assignee(s),
• and the manufacturing process claims (viral inactivation, purification steps, stabilization agents, and potency determination). Without a product name anchor, any list of patents would be incomplete and not litigation-ready.

Patent clusters typically seen in HBIG-IV families

Where patent portfolios exist, they usually fall into:

• Manufacturing and viral inactivation (validated steps, orthogonal clearance methods)
• Formulation and stabilization (buffers, sugars, concentration ranges)
• Potency assays and release criteria
• Methods of use (transplant prophylaxis protocols, PEP schedules, combination use with antivirals/vaccination)

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What Paragraph IV challenges exist for hepatitis B immune globulin intravenous (human), and what are the legal risks?

Paragraph IV is an ANDA-specific construct for small molecules. For HBIG-IV, the relevant litigation and challenges typically follow biologics or interchange/labeling disputes, not an ANDA Paragraph IV framework. A “Paragraph IV” inventory cannot be produced without case-specific data tied to a specific US product.

Practical litigation risk categories for HBIG-IV

For plasma-derived immunoglobulins, disputes tend to involve:

• BLA labeling and interchangeability
• cGMP manufacturing compliance and comparability
• patent infringement assertions related to manufacturing processes or formulations

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How do hepatitis B immune globulin intravenous (human) market dynamics compare with HBV antivirals and vaccination-only strategies?

Featured snippet answer: HBV antivirals and vaccination protocols can reduce the need for HBIG in some clinical pathways, but they do not fully replace HBIG in high-risk settings where passive immunity is required.

Competitive substitutions that compress HBIG-IV growth

• Vaccination-first strategies: For many post-vaccination and low-risk exposures, vaccination and monitoring may reduce HBIG use.
• Antiviral bridging in transplant and high-risk care: Combination prophylaxis may reduce duration and dose intensity of HBIG in some protocols.

Where HBIG-IV retains relevance

• Cases requiring immediate passive immunity where vaccination response is uncertain or delayed.
• High-risk clinical settings where viral recurrence must be prevented early, often before immune response fully establishes.

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What is the current market size, key geographies, and procurement structure for hepatitis B immune globulin intravenous (human)?

A precise market size, revenue by geography, and procurement-level forecast cannot be produced without a specific product identifier and sponsor data because HBIG-IV spans multiple branded products and different market shares by tendering authority. A credible forecast must be anchored to:

• specific products and dosages sold,
• national procurement frameworks (tender vs reimbursed),
• and historical volumes.

Market structure drivers for HBIG-IV

• Hospital procurement and tenders dominate buyer behavior.
• Plasma-derived supply constraints can change lead times and pricing.
• Guideline adherence limits off-protocol demand.

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What is the revenue projection for hepatitis B immune globulin intravenous (human) through 2036?

A product-specific revenue projection cannot be produced without:

• the specific HBIG-IV product(s),
• historical sales baselines,
• and region-level distribution data. Any numeric forecast would be non-actionable and not audit-ready for investment, licensing, or litigation strategy.

Forecast logic that would typically support a projection (non-numeric)

• Transplant volume trend and recurrence prophylaxis protocol changes.
• PEP guideline updates affecting eligibility.
• Adoption of combination prophylaxis that may reduce HBIG exposure.
• Supply reliability and tender pass-through effects.

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What risks could delay or reduce future clinical adoption of hepatitis B immune globulin intravenous (human)?

Key risks for HBIG-IV are structural rather than purely clinical:

• Supply continuity: Plasma-derived biologics depend on upstream collection, fractionation, and manufacturing throughput.
• Quality and compliance: Release potency assay performance and viral inactivation validation are continuous operational requirements.
• Protocol changes: Even if efficacy remains strong, clinical pathways can shift toward more antiviral-centric or vaccination-centric prophylaxis.

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Key Takeaways

• Hepatitis B immune globulin intravenous (human) is a niche, procurement-driven HBV prophylaxis product with finite dosing courses that cap addressable growth.
• Demand is primarily linked to exposure management and high-risk clinical pathways such as post-liver-transplant prophylaxis.
• Market upside depends more on clinical protocol utilization rates, tender dynamics, and supply continuity than on expanded chronic indications.
• A detailed, decision-grade clinical and IP update requires a specific product identifier to map trials, exclusivities, patents, and regulatory status to a defined BLA and branded product.

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FAQs

1. How is hepatitis B immune globulin intravenous (human) used for healthcare worker exposure management?
2. What is the typical duration of HBIG-IV prophylaxis after liver transplantation, and what factors change it?
3. How do antivirals and HBV vaccination protocols reduce HBIG-IV utilization?
4. What manufacturing risks most often disrupt supply of plasma-derived immune globulin products?
5. What regulatory pathway and interchange framework govern HBIG-IV products in the US?

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References

1. FDA. “Biologics License Application (BLA) Information.” U.S. Food and Drug Administration. https://www.fda.gov/
2. WHO. “Hepatitis B.” World Health Organization. https://www.who.int/
3. CDC. “Prevention of Hepatitis B Virus Infection in the United States.” Centers for Disease Control and Prevention. https://www.cdc.gov/