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Last Updated: May 11, 2021

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CLINICAL TRIALS PROFILE FOR HYALURONIDASE RECOMBINANT HUMAN

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505(b)(2) Clinical Trials for Hyaluronidase Recombinant 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 NCT01839487 PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Untreated Pancreatic Cancer Active, not recruiting Halozyme Therapeutics Phase 2 2013-04-01 To compare the treatment effect of PEGPH20 combined with nab-paclitaxel and gemcitabine (PAG) to nab-paclitaxel and gemcitabine (AG) in subjects with Stage IV pancreatic cancer. The Phase 2 will study safety and treatment effect in 237 subjects (2:1 randomization, PAG:AG), preceded by two run-in phases (the first to assess safety and tolerability and a second to assess a new formulation of PEGHP20), 16 subjects total (randomized 3:1).
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Hyaluronidase Recombinant Human

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000493 Multicenter Investigation of Limitation of Infarct Size (MILIS) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1977-09-01 To assess the ability of two separate therapeutic interventions, propranolol and hyaluronidase, to limit the ultimate size of an acute myocardial infarction. A secondary objective was to assess the influence of these therapies upon ventricular function and morbidity following myocardial infarction.
NCT00198419 Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase) Completed Bausch & Lomb Incorporated Phase 1 2004-03-01 The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to 10% hypersensitivity response was considered acceptable.
NCT00198458 Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase) Completed Bausch & Lomb Incorporated Phase 1 2004-07-01 The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to a 10% hypersensitivity response was considered acceptable.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Hyaluronidase Recombinant Human

Condition Name

Condition Name for Hyaluronidase Recombinant Human
Intervention Trials
Type 1 Diabetes Mellitus 6
Healthy 5
Dehydration 5
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Condition MeSH

Condition MeSH for Hyaluronidase Recombinant Human
Intervention Trials
Diabetes Mellitus 12
Diabetes Mellitus, Type 1 8
Dehydration 5
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Clinical Trial Locations for Hyaluronidase Recombinant Human

Trials by Country

Trials by Country for Hyaluronidase Recombinant Human
Location Trials
United States 261
Canada 12
United Kingdom 11
Brazil 11
France 11
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Trials by US State

Trials by US State for Hyaluronidase Recombinant Human
Location Trials
California 30
Texas 14
New York 14
Washington 12
Michigan 12
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Clinical Trial Progress for Hyaluronidase Recombinant Human

Clinical Trial Phase

Clinical Trial Phase for Hyaluronidase Recombinant Human
Clinical Trial Phase Trials
Phase 4 15
Phase 3 12
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Hyaluronidase Recombinant Human
Clinical Trial Phase Trials
Completed 41
Not yet recruiting 20
Recruiting 10
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Clinical Trial Sponsors for Hyaluronidase Recombinant Human

Sponsor Name

Sponsor Name for Hyaluronidase Recombinant Human
Sponsor Trials
Halozyme Therapeutics 35
Baxter Healthcare Corporation 7
Bausch & Lomb Incorporated 6
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Sponsor Type

Sponsor Type for Hyaluronidase Recombinant Human
Sponsor Trials
Industry 60
Other 55
NIH 8
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