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.

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.

Clinical Trial Conditions for Albumin Human

Condition Name

Condition Name for Albumin Human
Intervention	Trials
Breast Cancer	47
Diabetic Nephropathy	38
Diabetes Mellitus, Type 2	29

Condition MeSH

Condition MeSH for Albumin Human
Intervention	Trials
Kidney Diseases	120
Breast Neoplasms	97
Diabetes Mellitus	96

Clinical Trial Locations for Albumin Human

Trials by Country

Trials by Country for Albumin Human
Location	Trials
China	305
Canada	157
Italy	97
Spain	87
Australia	80

Trials by US State

Trials by US State for Albumin Human
Location	Trials
California	103
New York	92
Texas	81
Illinois	78
Maryland	65

Clinical Trial Progress for Albumin Human

Clinical Trial Phase

Clinical Trial Phase for Albumin Human
Clinical Trial Phase	Trials
Phase 4	276
Phase 3	181
Phase 2/Phase 3	45

Clinical Trial Status

Clinical Trial Status for Albumin Human
Clinical Trial Phase	Trials
Completed	559
Recruiting	246
Not yet recruiting	181

Clinical Trial Sponsors for Albumin Human

Sponsor Name

Sponsor Name for Albumin Human
Sponsor	Trials
National Cancer Institute (NCI)	68
Celgene Corporation	32
Institute of Liver and Biliary Sciences, India	23

Sponsor Type

Sponsor Type for Albumin Human
Sponsor	Trials
Other	1761
Industry	495
NIH	137

Albumin Human: Clinical Trials, Market Analysis, and Projections

Overview of Albumin Human

Albumin, a key protein found in human blood, plays a crucial role in maintaining blood volume and transporting hormones, vitamins, drugs, and calcium throughout the body. Human serum albumin, whether derived from plasma or produced recombinantly, is a vital component in various medical treatments.

Clinical Trials Update

Recombinant Human Serum Albumin (rHSA)

Several clinical trials are underway to evaluate the safety and efficacy of recombinant human serum albumin (rHSA), particularly in patients with conditions such as hepatic cirrhosis and ascites.

Hepatic Cirrhosis and Ascites

• A Phase 2/3 clinical trial, initiated in August 2024, is comparing the effectiveness and safety of rHSA versus human serum albumin in patients with hepatic cirrhosis and ascites. This trial adopts a random, double-blind, positive control, parallel group design[1][4].
• Another completed Phase 2/3 trial, started in May 2023, also evaluated the efficacy and safety of rHSA in cirrhotic ascites patients using a similar design[1].

Alzheimer's Disease

• An open-label, parallel-group exploratory clinical trial, started in June 2024, is investigating the safety and preliminary efficacy of rHSA in patients with mild to moderate Alzheimer's disease. Participants are randomized to receive doses of 20g, 30g, or 40g of rHSA[1].

Key Indications

• Active indications for rHSA include ascites, liver cirrhosis, and cirrhotic cardiomyopathy.
• Inactive indications include fibrosis, though this may change as more research emerges[1].

Market Analysis

Global Albumin Market Size and Trends

• The global albumin market was valued at $5.4 billion in 2022 and is projected to reach $9.9 billion by 2032, growing at a CAGR of 6.2% from 2023 to 2032[2].
• Another forecast suggests the market could reach $12.51 billion by 2037, growing at a CAGR of around 6.4% from 2024 to 2037[3].

Market Segmentation

• By Type: The human serum albumin segment dominated the market in terms of revenue in 2022 and is expected to grow at the fastest CAGR during the forecast period[2][3].
• By Application: The therapeutics segment dominated the market in terms of revenue in 2022 and is anticipated to grow at the fastest CAGR during the forecast period. Albumin is crucial in therapeutic interventions, especially in scenarios involving trauma, burns, and shock[2][3].
• By Sales Channel: The B2B segment dominated the market in 2022, but the B2C segment is expected to grow at the fastest CAGR during the forecast period. This shift is driven by direct sales to individual consumers, enhancing market accessibility and customer engagement[2].

Regional Analysis

• North America generated the largest revenue in 2022 due to advanced medical technologies and a well-developed healthcare network. However, the Asia-Pacific region is anticipated to grow at the highest CAGR during the forecast period[2].

Growth Drivers

Increasing Prevalence of Diseases

• The prevalence of diseases such as hypoalbuminemia, burns, trauma, liver cirrhosis, and cardiac surgeries significantly propels the growth of the albumin market[2][5].

Technological Advancements

• The surge in the development of new medications and the increasing expenditure in R&D in the pharmaceutical industry drive the demand for human serum albumin. It is often used to improve the stability, solubility, and bioavailability of drugs[3].

Expanded Applications

• Albumin is finding expanded applications in novel treatments for diseases like cancer and in blood plasma protein therapies. It is also being utilized in drug formulations for targeted delivery during clinical trials[5].

Recombinant Human Albumin: A Promising Substitute

Advantages Over Plasma-Derived Albumin

• Recombinant human albumin offers reduced costs, consistent quality, and diminished contamination risks associated with blood products. This shift promises to be a significant driver in the market's growth[5].

Key Takeaways

• The global albumin market is expected to grow significantly, driven by the increasing prevalence of diseases and technological advancements.
• Recombinant human serum albumin is being extensively studied in clinical trials for various indications, including hepatic cirrhosis and Alzheimer's disease.
• The market is segmented by type, application, and sales channel, with the therapeutics segment and B2B sales channel currently dominating.
• North America is the largest market, but the Asia-Pacific region is expected to grow at the highest CAGR.

FAQs

What is the current market size of the global albumin market?

The global albumin market was valued at $5.4 billion in 2022[2].

What is the projected growth rate of the global albumin market?

The market is projected to grow at a CAGR of 6.2% from 2023 to 2032 and around 6.4% from 2024 to 2037[2][3].

What are the primary indications for recombinant human serum albumin?

Primary indications include ascites, liver cirrhosis, and cirrhotic cardiomyopathy[1].

Why is recombinant human albumin gaining traction over plasma-derived albumin?

Recombinant human albumin offers reduced costs, consistent quality, and diminished contamination risks associated with blood products[5].

Which region is expected to grow at the highest CAGR in the albumin market?

The Asia-Pacific region is anticipated to grow at the highest CAGR during the forecast period[2].

Sources

1. Patsnap Synapse: Recombinant Human Serum Albumin(Protgen Ltd.).
2. Allied Market Research: Albumin Market Size, Share | Growth Drivers | Forecast- 2032.
3. Research Nester: Albumin Market Size & Share | Growth Forecasts 2037.
4. Veeva Clinical Trials: Phase II/III Clinical Trial of Recombinant Human Serum Albumin in Cirrhotic Patients With Ascites.
5. Mordor Intelligence: Albumin Market Size Analysis and Growth Report.