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Last Updated: November 26, 2022

CLINICAL TRIALS PROFILE FOR ALBUMIN HUMAN


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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).
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Albumin Human

Condition Name

Condition Name for Albumin Human
Intervention Trials
Breast Cancer 45
Diabetic Nephropathy 38
Diabetes Mellitus, Type 2 26
Hypertension 25
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Condition MeSH

Condition MeSH for Albumin Human
Intervention Trials
Kidney Diseases 111
Breast Neoplasms 92
Diabetes Mellitus 82
Diabetes Mellitus, Type 2 80
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Clinical Trial Locations for Albumin Human

Trials by Country

Trials by Country for Albumin Human
Location Trials
China 259
Canada 153
Italy 91
Spain 86
Australia 80
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Trials by US State

Trials by US State for Albumin Human
Location Trials
California 102
New York 90
Texas 79
Illinois 77
Florida 64
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Clinical Trial Progress for Albumin Human

Clinical Trial Phase

Clinical Trial Phase for Albumin Human
Clinical Trial Phase Trials
Phase 4 262
Phase 3 167
Phase 2/Phase 3 43
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Clinical Trial Status

Clinical Trial Status for Albumin Human
Clinical Trial Phase Trials
Completed 556
Recruiting 201
Unknown status 166
[disabled in preview] 130
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Clinical Trial Sponsors for Albumin Human

Sponsor Name

Sponsor Name for Albumin Human
Sponsor Trials
National Cancer Institute (NCI) 68
Celgene Corporation 32
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 23
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Sponsor Type

Sponsor Type for Albumin Human
Sponsor Trials
Other 1661
Industry 464
NIH 136
[disabled in preview] 13
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