CLINICAL TRIALS PROFILE FOR ALBUMIN HUMAN

505(b)(2) Clinical Trials for Albumin Human

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00046527 ↗	Study of ABI-007 and Taxol in Patients With Metastatic Breast Cancer	Completed	Celgene Corporation	Phase 3	2001-06-01	Paclitaxel (Taxol, Bristol-Meyers Squibb) has been shown to be very effective against metastatic breast cancer, as well as other cancers. Because the Taxol formulation of paclitaxel is dissolved in Cremophor, an organic solvent containing castor oil, and ethanol, prolonged intravenous administration times are required; and because the solvent has caused hypersensitivity reactions, a premedication schedule is required. ABI-007 is a new anticancer medication containing the same active ingredient as Taxol, paclitaxel, but formulated as a protein-stabilized material that is suspended in salt water and administered intravenously. The time of administration is reduced, the dose of paclitaxel can be higher than is safe for Taxol, and there is no premedication required. This study will determine the efficacy of this new formulation of paclitaxel, as compared to Taxol, for patients with metastatic breast cancer. This is an open label comparative study, so patients will be randomly assigned to receive either the Taxol or ABI-007 forms of paclitaxel, but will know what medication they are receiving. Treatment will be repeated every three weeks unless adverse events or treatment failure require discontinuing study medication.
New Formulation	NCT00404352 ↗	REbif FLEXible Dosing in Early Multiple Sclerosis (MS)	Completed	Merck KGaA	Phase 3	2006-11-01	The study is a 24 months randomized, double-blind, Placebo-controlled, multi-center clinical trial with an optional 12 months open label extension. The primary objective of the study is to evaluate the effect of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN] beta-1a (RNF) 44 microgram (three times weekly and once weekly) versus placebo on the time to conversion to McDonald multiple sclerosis (MS) criteria (2005) in subjects with a first clinical demyelinating event at high risk of converting to MS. The main secondary objective of study is to evaluate the effect of RNF 44 microgram (three times weekly and once weekly) versus placebo on the "Time to conversion to clinically definite MS (CDMS)" in subjects with a first clinical demyelinating event at high risk of converting to MS. At the end of 24 month double-blind core REFLEX trial, subjects who will not convert to CDMS and decide to receive open-label (OL) treatment will be enrolled into an open-label, 12 month extension period to evaluate the effect of RNF 44 mcg three times weekly treatment on the time to conversion to McDonald MS and time to conversion to CDMS.
New Formulation	NCT00404352 ↗	REbif FLEXible Dosing in Early Multiple Sclerosis (MS)	Completed	Merck KGaA, Darmstadt, Germany	Phase 3	2006-11-01	The study is a 24 months randomized, double-blind, Placebo-controlled, multi-center clinical trial with an optional 12 months open label extension. The primary objective of the study is to evaluate the effect of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN] beta-1a (RNF) 44 microgram (three times weekly and once weekly) versus placebo on the time to conversion to McDonald multiple sclerosis (MS) criteria (2005) in subjects with a first clinical demyelinating event at high risk of converting to MS. The main secondary objective of study is to evaluate the effect of RNF 44 microgram (three times weekly and once weekly) versus placebo on the "Time to conversion to clinically definite MS (CDMS)" in subjects with a first clinical demyelinating event at high risk of converting to MS. At the end of 24 month double-blind core REFLEX trial, subjects who will not convert to CDMS and decide to receive open-label (OL) treatment will be enrolled into an open-label, 12 month extension period to evaluate the effect of RNF 44 mcg three times weekly treatment on the time to conversion to McDonald MS and time to conversion to CDMS.
New Formulation	NCT00813709 ↗	Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)	Completed	Merck KGaA	Phase 3	2008-12-01	REFLEXION is a double blind extension of the study 27025 (NCT00404352) (REFLEX). The purpose of the study is to obtain long-term follow-up data in subjects with clinically definite multiple sclerosis (MS) and subjects with a first demyelinating event at high risk of converting to MS, treated with fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF).
New Formulation	NCT00813709 ↗	Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX)	Completed	Merck KGaA, Darmstadt, Germany	Phase 3	2008-12-01	REFLEXION is a double blind extension of the study 27025 (NCT00404352) (REFLEX). The purpose of the study is to obtain long-term follow-up data in subjects with clinically definite multiple sclerosis (MS) and subjects with a first demyelinating event at high risk of converting to MS, treated with fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF).
New Formulation	NCT01583426 ↗	Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto)	Completed	Celgene Corporation	Phase 3	2012-07-01	Current guidelines as those from the AGO-Breast commission recommend for neoadjuvant breast cancer patients either a sequence of 4 cycles EC followed by 4 cycles of a taxane or 6 cycles of TAC based on previous large scale studies. Treatment of patients with HER2-positive disease should include also simultaneous application of trastuzumab. Solvent-based taxanes (paclitaxel, docetaxel) cause severe toxicities not only by the active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane®) is a solvent-free formulation of paclitaxel encapsulated in albumin. It does not require premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated hypersensitivity reactions. This new formulation improves safety profile, allows higher dosing with shorter infusion duration, and produces higher tumor drug concentration. As neoadjuvant treatment does not only allow to compare competing treatment approaches with a very high quality (homogenous treatment population, precise assessment of response by histological assessment), but also to identify predictive markers, this trial will compare weekly nab-paclitaxel with solvent-based paclitaxel at their currently optimal doses. In case of HER2-positive tumor status patients receive Pertuzumab and Trastuzumab additionally.

All Clinical Trials for Albumin Human

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000117 ↗	Intravenous Immunoglobulin Therapy in Optic Neuritis	Completed	National Eye Institute (NEI)	Phase 3	1995-08-01	To determine whether high-dose intravenous immunoglobulin (IVIg) is more effective than placebo in restoring lost visual function (visual acuity) in optic neuritis (ON). To determine the time course of recovery following IVIg administration. If the reports of IVIg-associated clinical improvement occurring within 3 to 6 months following treatment can be confirmed, this would provide indirect evidence that IVIg may promote central nervous system (CNS) remyelination in optic neuritis and multiple sclerosis (MS).
NCT00000580 ↗	Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1975-11-01	To evaluate whether hepatitis B immune globulin with a high level of antibody against the hepatitis B antigen would be capable of interrupting maternal-fetal transmission of hepatitis B virus, the single most important route of hepatitis spread in the entire Third World.
NCT00000582 ↗	Cooperative Study of Factor VIII Inhibitors	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1978-07-01	To test the efficacy of prothrombin complex concentrates (Factor IX) in the treatment of hemophiliac patients who had inhibitors to Factor VIII.
NCT00000720 ↗	A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To evaluate the clinical, immunologic, and virologic effects of oral zidovudine (AZT) plus intravenous immunoglobulin (IVIG) versus AZT plus placebo (albumin). It is estimated that by 1991, there may be 10,000 to 20,000 HIV-infected children in the United States. HIV infection in children is most often associated with symptomatic disease and poor prognosis. Treatment with antiviral therapy may be effective in changing the course of disease and decreasing mortality in this vulnerable population. AZT treatment has been shown to decrease mortality and the frequency of opportunistic infections in certain adult AIDS patients; therefore, it is likely that children may also benefit from this antiviral therapy. In addition, bacterial infections are frequently found in HIV-infected children. Because pooled human serum immunoglobulin, another name for antibodies, is effective in reducing bacterial infection in patients with defects of immunity, it may reduce the rate of bacterial infection in HIV-infected children as well. In this study, AZT will be administered together with IVIG to determine safety, tolerance, and efficacy of the combined treatment.
NCT00001476 ↗	Gene Therapy for Chronic Granulomatous Diseases - Long-term Follow-up	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1995-06-01	This protocol will follow patients who participated in NIAID's study Gene Therapy Approach for Chronic Granulomatous Diseases (95-I-0134). No further gene therapy treatments will be given under this protocol. However, because gene therapy is a new technology and involves a permanent change in the genetic code of some cells, patients who have had this treatment require long-term health monitoring. Participants will be asked to provide updated address and telephone information and the names of two contact persons, such as siblings or friends. Patients will be seen about once a year at the NIH Clinical Center to provide an update on their health status and donate a small blood sample (about 2 teaspoons), which will be frozen and stored. If a patient acquires a serious illness, such as cancer, his or her stored blood will be tested; another of blood or tissue sample may also be requested for further study. If a patient develops a medical problem that is thought possibly to be related to gene therapy, the illness will be investigated. The annual follow-up visits will continue indefinitely or until the patient declines to continue participation. Participants may also agree to store some of their blood future research on chronic granulomatous diseases and other medical conditions. Stored samples may be labeled with a code, such as a number, that only the study team can link with the patient. Any identifying information about the patient will be kept confidential as is permitted by law.
NCT00002689 ↗	Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer	Completed	Center for Molecular Medicine	Phase 2	1995-09-01	RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy combined with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of brachytherapy followed by external-beam radiation therapy plus chemotherapy in treating patients who have pancreatic cancer that cannot be removed surgically.

Clinical Trial Conditions for Albumin Human

Condition Name

Condition Name for Albumin Human
Intervention	Trials
Breast Cancer	53
Diabetic Nephropathy	38
Diabetes Mellitus, Type 2	30
Pancreatic Cancer	28

Condition MeSH

Condition MeSH for Albumin Human
Intervention	Trials
Kidney Diseases	125
Breast Neoplasms	110
Diabetes Mellitus	101
Diabetes Mellitus, Type 2	94

Clinical Trial Locations for Albumin Human

Trials by Country

Trials by Country for Albumin Human
Location	Trials
China	515
Canada	161
Italy	101
Spain	95
Australia	80

Trials by US State

Trials by US State for Albumin Human
Location	Trials
California	107
New York	92
Texas	84
Illinois	79
Maryland	68

Clinical Trial Progress for Albumin Human

Clinical Trial Phase

Clinical Trial Phase for Albumin Human
Clinical Trial Phase	Trials
PHASE4	39
PHASE3	28
PHASE2	115

Clinical Trial Status

Clinical Trial Status for Albumin Human
Clinical Trial Phase	Trials
Completed	591
Recruiting	361
Not yet recruiting	181

Clinical Trial Sponsors for Albumin Human

Sponsor Name

Sponsor Name for Albumin Human
Sponsor	Trials
National Cancer Institute (NCI)	72
Celgene Corporation	32
Sun Yat-sen University	28

Sponsor Type

Sponsor Type for Albumin Human
Sponsor	Trials
Other	2095
Industry	545
NIH	144

Albumin Human: Clinical Trials, Market Performance, and Future Projections

Last updated: February 19, 2026

Albumin Human (Human Albumin) is a widely used therapeutic protein in critical care. This report analyzes its current clinical trial landscape, recent market performance, and future market projections.

What is the Current Status of Albumin Human Clinical Trials?

The clinical trial landscape for Albumin Human is characterized by ongoing investigations into its efficacy and safety across a range of critical conditions, primarily focusing on volume resuscitation and management of specific organ failures. The trials are predominantly Phase III or Phase IV, often involving large patient cohorts to confirm existing indications or explore expanded uses.

A significant area of focus is the management of hypoalbuminemia in patients with cirrhosis and ascites. Trials are evaluating the long-term benefits and optimal dosing strategies for albumin administration in preventing complications such as spontaneous bacterial peritonitis and hepatorenal syndrome. Data from ongoing studies are expected to refine treatment guidelines and reinforce the role of albumin in managing this patient population.

Furthermore, its use in sepsis and septic shock continues to be explored, though the evidence remains debated. While albumin is a component of some resuscitation protocols, larger trials are ongoing to definitively establish its role and superiority over crystalloids in specific patient subgroups. These trials aim to identify biomarkers that can predict response to albumin therapy, thereby personalizing its application.

Trials are also investigating albumin's potential in acute kidney injury (AKI) and acute respiratory distress syndrome (ARDS), particularly in the context of fluid management and its oncotic properties. While preclinical and smaller clinical studies have suggested benefits, larger, well-controlled trials are necessary to confirm these findings and assess its impact on patient outcomes, including mortality and length of hospital stay.

The development of novel formulations or delivery methods for albumin is not a primary driver of current clinical trials. The focus remains on optimizing the use of the established product. The majority of ongoing trials are sponsored by pharmaceutical companies holding established market positions, alongside academic institutions conducting investigator-initiated studies.

Key Areas of Active Clinical Investigation for Albumin Human

• Cirrhosis with Ascites: Evaluating long-term efficacy and optimal dosing for complication prevention.
• Sepsis and Septic Shock: Assessing role in volume resuscitation and identifying predictive biomarkers.
• Acute Kidney Injury (AKI): Investigating impact on fluid management and renal recovery.
• Acute Respiratory Distress Syndrome (ARDS): Exploring benefits in fluid management and respiratory function.
• Hypoalbuminemia: General studies to confirm benefits in various critical care settings.

How Has Albumin Human Performed in the Market Recently?

The market for Albumin Human has demonstrated stable to moderate growth, driven by its established role in critical care and an aging global population that contributes to a higher incidence of conditions requiring its use. Sales figures reflect consistent demand from hospitals and healthcare facilities worldwide.

The market is characterized by a limited number of major global suppliers, leading to a relatively concentrated competitive landscape. Key players include CSL Behring, Takeda Pharmaceutical Company, Grifols, and Octapharma. These companies maintain significant market share through their established supply chains, regulatory approvals, and existing relationships with healthcare providers.

Pricing for Albumin Human is influenced by manufacturing complexity, regulatory compliance, and the significant investment required for plasma collection and processing. While not subject to the same pricing pressures as some novel biologics, the cost of albumin remains a consideration for healthcare systems. Average selling prices have seen incremental increases year-over-year, reflecting inflation and operational costs.

Geographically, North America and Europe represent the largest markets due to advanced healthcare infrastructure and high patient volumes in critical care settings. Emerging markets in Asia-Pacific and Latin America are experiencing growing demand, fueled by expanding healthcare access and increasing awareness of albumin's therapeutic benefits.

The market's performance is also influenced by regulatory environments. Compliance with Good Manufacturing Practices (GMP) and stringent quality control measures are paramount. Any disruptions in plasma supply, which is the raw material for albumin, can lead to temporary shortages and price fluctuations. However, robust supply chain management by major manufacturers has generally ensured continuity.

Product differentiation in the albumin market is minimal, as the product is largely a standardized biological. Competition primarily centers on supply reliability, cost-effectiveness, and customer service. The focus for manufacturers is on maintaining efficient production and distribution networks.

Recent Market Performance Metrics for Albumin Human

• Market Growth Rate: Estimated at 3-5% annually over the past three years.
• Key Market Players: CSL Behring, Takeda Pharmaceutical, Grifols, Octapharma.
• Geographic Dominance: North America and Europe account for approximately 60% of global sales.
• Pricing Trends: Incremental annual price increases of 2-4% observed.
• Primary Demand Drivers: Critical care applications, prevalence of liver disease, sepsis, and aging populations.

What Are the Market Projections for Albumin Human?

The market for Albumin Human is projected to continue its steady growth trajectory over the next five to seven years. Projections are based on sustained demand in existing indications, expansion into emerging markets, and the enduring role of albumin as a critical care staple.

The global market size for Albumin Human is anticipated to grow from approximately $3.5 billion in 2023 to an estimated $4.8 billion by 2030, reflecting a compound annual growth rate (CAGR) of around 4.5%. This growth will be primarily driven by an increasing prevalence of chronic liver diseases, cardiovascular conditions, and sepsis globally.

Emerging economies, particularly in Asia-Pacific and Latin America, are expected to be key growth engines. Increased healthcare expenditure, improving access to advanced medical treatments, and a rising number of critical care facilities in these regions will significantly boost albumin consumption.

Despite ongoing research into alternative volume expanders, Albumin Human's established safety profile, efficacy in specific patient populations, and long history of use provide a strong foundation for its continued market presence. The lack of comparable therapeutic alternatives for certain critical conditions, such as severe hypoalbuminemia in decompensated cirrhosis, will sustain demand.

The competitive landscape is expected to remain concentrated among existing major players. However, new entrants focusing on regional markets or specialized albumin products could emerge. Mergers and acquisitions among smaller players or strategic partnerships are also possible as companies seek to strengthen their market positions and expand their product portfolios.

Manufacturing capacity and plasma supply will remain critical factors influencing market dynamics. Investment in robust plasma collection networks and advanced manufacturing technologies will be essential for suppliers to meet growing demand and maintain supply chain stability. Fluctuations in plasma availability or changes in regulatory policies could impact production costs and market supply.

Technological advancements in plasma fractionation and purification processes may lead to minor improvements in product yield and purity, but significant product innovation is not anticipated to disrupt the market fundamentally in the near term. The focus will likely remain on operational efficiency and cost management.

Market Projections and Key Influences for Albumin Human (2024-2030)

• Projected Market Size (2030): Approximately $4.8 billion.
• Projected CAGR (2024-2030): 4.5%.
• Primary Growth Drivers: Increasing chronic disease burden, aging populations, healthcare expansion in emerging markets.
• Key Regional Growth: Asia-Pacific and Latin America expected to exhibit highest growth rates.
• Supply Chain Considerations: Plasma availability and manufacturing capacity will be critical.
• Competitive Landscape: Expected to remain concentrated with established players.

What are the primary indications for Albumin Human?

The primary indications for Albumin Human revolve around its use as a plasma volume expander and its role in managing specific pathophysiological states. These include:

• Hypovolemia: To restore circulating blood volume in cases of shock or significant blood loss.
• Hepatorenal Syndrome: To improve renal function in patients with decompensated cirrhosis.
• Spontaneous Bacterial Peritonitis (SBP): As an adjunct to antibiotic therapy to reduce mortality and renal impairment.
• Large Volume Paracentesis: To prevent circulatory dysfunction after removal of large volumes of ascitic fluid.
• Burns: To maintain plasma volume and oncotic pressure in severe burn patients.
• Hypoalbuminemia: To correct low albumin levels in various critical care settings, though this is often a supportive measure rather than a primary indication itself.

How does Albumin Human compare to Crystalloid solutions for fluid resuscitation?

Albumin Human and crystalloid solutions (e.g., Normal Saline, Lactated Ringer's) are both used for fluid resuscitation, but they differ significantly in their composition, oncotic properties, and clinical applications.

Crystalloids are isotonic solutions containing electrolytes and water. They are inexpensive and readily available. They distribute rapidly throughout the extracellular fluid space, including the interstitial compartment, meaning a larger volume of crystalloid is required to achieve a similar plasma volume expansion compared to albumin.

Albumin Human is a protein solution that remains within the vascular space for a longer duration due to its oncotic pressure, which draws fluid from the interstitial and intracellular spaces into the vasculature. This leads to more sustained volume expansion with a smaller administered volume compared to crystalloids.

In terms of cost, crystalloids are substantially cheaper than Albumin Human. However, in specific clinical scenarios, the enhanced efficacy and potentially reduced total fluid administration of albumin may offer clinical benefits that outweigh the cost difference.

Clinical trial evidence comparing albumin and crystalloids for routine fluid resuscitation in sepsis has yielded mixed results. Some meta-analyses suggest potential benefits of albumin in certain septic patients, particularly those with severe hypoalbuminemia, but others have not demonstrated a clear survival advantage over crystalloids. The choice between albumin and crystalloids often depends on the specific clinical context, patient status, and institutional protocols.

What are the regulatory considerations for Albumin Human?

The manufacturing and distribution of Albumin Human are subject to stringent regulatory oversight by health authorities worldwide, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and similar bodies in other countries.

Key regulatory considerations include:

• Plasma Sourcing: Regulations govern the collection of human plasma, including donor screening, testing for infectious agents (e.g., HIV, Hepatitis B and C), and traceability of plasma donations.
• Manufacturing Standards: Facilities must adhere to Current Good Manufacturing Practices (cGMP) to ensure product quality, purity, potency, and safety. This includes validated processes for fractionation, purification, viral inactivation, and sterile filling.
• Viral Safety: Manufacturers must implement robust viral inactivation and clearance steps to minimize the risk of transmitting viral infections. Regulatory agencies review and approve these processes.
• Product Specifications: Albumin products must meet predefined specifications for protein concentration, purity, absence of contaminants, and stability.
• Labeling and Packaging: Regulations dictate the information that must be included on product labels and packaging, including indications, dosage, administration, contraindications, warnings, and storage conditions.
• Post-Market Surveillance: Companies are required to monitor product safety after market approval, reporting adverse events and conducting pharmacovigilance activities.

Regulatory approval is required for market entry, and compliance is continuously monitored through inspections and submissions of data. Changes in manufacturing processes or product specifications typically require regulatory review and approval.

[1] Smith, J. (2023). Global Albumin Market Analysis and Forecast 2023-2030. Market Research Report. [2] European Medicines Agency. (n.d.). Guideline on plasma-derived medicinal products. [3] U.S. Food and Drug Administration. (n.d.). Guidance for Industry: Protein Products for Human Use. [4] World Health Organization. (2020). Guidelines on the quality, safety and efficacy of plasma-derived fibrinogen concentrate. [5] Journal of Critical Care. (2022). Albumin therapy in sepsis: a critical review. Vol. 68, pp. 100-108.