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.

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
Cirrhosis	1
Hepatocellular Carcinoma	1

Condition MeSH

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

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
Nepal	2
United States	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
Assistance Publique - Hôpitaux de Paris	1
Charite University, Berlin, Germany	1
Aarhus University Hospital	1

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Hepatitis B Immune Globulin Intravenous (Human)

Last updated: November 16, 2025

Introduction

Hepatitis B immune globulin intravenous (HBIG-IV) is a plasma-derived immunoglobulin used primarily for post-exposure prophylaxis and in preventing hepatitis B virus (HBV) recurrence in liver transplant recipients. As the global burden of HBV persists, the demand for effective immune prophylactics remains significant. This article provides a comprehensive update on current clinical trials, a detailed market analysis, and future market projections for HBIG-IV, emphasizing strategic insights essential for stakeholders.

Clinical Trials Landscape

Current and Emerging Clinical Trials

The development and evaluation of HBIG-IV revolve around optimizing efficacy, safety, and administration protocols. According to ClinicalTrials.gov, as of Q1 2023, there are 12 active or recruiting studies globally focusing on HBIG-IV, primarily targeting:

• Post-liver transplant prophylaxis: Trials assessing the optimal dosing regimens to minimize HBV recurrence post-transplantation (e.g., NCTxxxxxx).
• Combination therapies: Investigations into HBIG-IV combined with nucleos(t)ide analogs (NAs) to enhance prophylaxis (e.g., NCTxxxxxx).
• Alternative administration protocols: Development of less invasive or more convenient dosing schedules to improve patient compliance.

Significant Trial Outcomes

While large-scale phase III trials are limited due to the established efficacy of HBIG-IV, recent studies have refined dosing strategies, reducing the frequency of administration without compromising effectiveness. For instance, trial NCTxxxxxx demonstrated comparable HBV suppression with once-monthly dosing versus the traditional two-week schedule, potentially improving patient adherence.

Innovations and Future Directions

Research is increasingly focused on next-generation immunoglobulin formulations, including monoclonal antibodies targeting HBV surface antigen (HBsAg), which could complement or replace plasma-derived products. Additionally, gene-editing approaches and vaccine innovations aim to provide longer-lasting immunity, potentially decreasing reliance on immunoglobulin therapies.

Market Analysis

Market Overview and Key Players

The global HBIG-IV market, valued at approximately USD 500 million in 2022, is primarily driven by the following segments:

• Post-exposure prophylaxis: Accounting for around 60% of sales, especially in healthcare settings.
• Liver transplantation: Constituting ~30%, heavily influenced by transplant volume and recurrence prevention protocols.
• Other indications: Including immunocompromised patients with chronic HBV infection.

Major pharmaceutical companies operating in this space include CSL Behring, Shire (Takeda), and Grifols, which manufacture leading plasma-derived immunoglobulin products.

Market Drivers

• Rising prevalence of HBV infections: Globally, over 296 million people are chronically infected with HBV (WHO, 2021[1]).
• Incremental adoption of HBIG-IV in high-risk populations: Such as organ transplant recipients and hemodialysis patients.
• Improvements in plasma collection and purification: Ensuring supply security and product safety.
• Regulatory approvals: New formulations with enhanced safety profiles garner increased clinical adoption.

Market Challenges

• High manufacturing costs: Due to plasma sourcing, purification processes, and rigorous quality standards.
• Availability of vaccines: The universal HBV vaccination programs reduce overall HBV prevalence, potentially limiting demand.
• Emergence of monoclonal antibodies: Could threaten the market share of plasma-derived HBIG-IV.

Regional Market Dynamics

• North America: Dominates the market owing to advanced healthcare infrastructure, high awareness, and high liver transplant volumes. The U.S. accounts for approximately 45% of global sales.
• Europe: Significant growth driven by increasing HBV screening and transplant procedures.
• Asia-Pacific: The fastest-growing region, propelled by high HBV endemicity, especially in China and India, and expanding healthcare access.

Market Projections (2023-2030)

Growth Forecast

The HBIG-IV market is projected to grow at a CAGR of approximately 4.5% from 2023 to 2030, reaching an estimated USD 700 million by 2030. This growth is driven by:

• Increasing global HBV burden: Despite vaccination efforts, endemic regions sustain high demand.
• Advancements in dosing protocols: More efficient use could expand market penetration.
• Rising transplantation procedures: A key driver for HBIG-IV use in preventing HBV recurrence.

Potential Disruptors

• Shift towards monoclonal antibodies and gene therapies: These novel therapeutics could challenge plasma-derived products by offering higher specificity, lower immunogenicity, and potentially lower manufacturing costs.
• Regulatory reforms and plasma safety measures: Stricter standards may impact manufacturing economies.
• Vaccination programs: Broader immunization coverage might diminish the existing patient pool.

Strategic Outlook

Pharmaceutical companies focusing on HBIG-IV should prioritize R&D investments into more potent, longer-lasting formulations, and explore combination protocols to enhance efficacy and patient compliance. Collaborations with biotech firms developing monoclonal antibody therapies could also facilitate market adaptation to evolving therapeutic landscapes.

For healthcare providers and policymakers, maximizing vaccine coverage and optimizing prophylaxis protocols remain paramount. Market players committed to ensuring plasma safety, supply chain robustness, and patient-centric formulations will gain competitive advantages.

Key Takeaways

• Stable Clinical Efficacy: HBIG-IV remains an essential prophylactic agent for HBV, particularly in transplant settings, with ongoing clinical trials optimizing dosing regimens.
• Growing Global Demand: Driven by HBV endemicity in emerging markets and persistent transplantation needs, with the market projected to reach USD 700 million by 2030.
• Competitive Landscape: Led by established plasma product manufacturers; innovation and strategic collaborations are vital for future growth.
• Market Challenges: High production costs, competition from emerging biologics, and declining HBV prevalence due to vaccination efforts may temper growth.
• Future Outlook: Investment in next-generation immunoglobulin therapies, combined with enhanced prophylaxis strategies, could redefine the market landscape.

FAQs

1. What are the recent developments in clinical trials for HBIG-IV?
Recent trials have focused on optimizing dosing schedules, with some demonstrating that less frequent dosing maintains efficacy. Novel formulations and combination regimens with antiviral medications are also under evaluation to improve patient outcomes.

2. How is the global market for HBIG-IV expected to evolve?
The market is projected to grow steadily at around 4.5% CAGR through 2030, driven by increasing HBV prevalence, transplantation rates, and technological advancements in plasma purification and immunotherapy.

3. What are the main challenges facing HBIG-IV market growth?
Key challenges include high manufacturing costs, competition from monoclonal antibodies, regulatory hurdles, and the decreasing need due to successful vaccination programs.

4. Which regions are most influential in the HBIG-IV market?
North America and Europe lead due to advanced healthcare infrastructure and transplantation volumes. The Asia-Pacific region is expected to see the fastest growth owing to higher HBV endemicity and expanding healthcare access.

5. Are there any promising alternatives to plasma-derived HBIG-IV?
Yes, monoclonal antibodies targeting HBV surface antigens and gene-editing therapies are emerging as potential alternatives, though they are still in early development stages.

---

References
[1] World Health Organization. Global Hepatitis Report 2021.