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Last Updated: May 21, 2022

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 Participants With Stage IV Untreated Pancreatic Cancer Completed Halozyme Therapeutics Phase 2 2013-05-14 This study is designed to compare the treatment effect of PEGPH20 combined with nab-paclitaxel (NAB) and gemcitabine (GEM) [PAG] to NAB and GEM [AG] in participants with Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). The study will have 2 run-in phases, one for each formulation of PEGPH20 (original and new formulations), and a Phase 2 portion. The 2 run-in phases will evaluate the safety and tolerability of the PAG treatment using the original and new succinic acid PEGPH20 formulation, respectively, compared with AG treatment. Phase 2 will have 2 stages due to a partial clinical hold that occurred from April through July 2014. The participants will be randomized in 3:1 for the run-in phases. The first stage will randomize participants in a 1:1 ratio. The second stage will randomize participants in a 2:1 ratio (PAG:AG). This is an open-label study. To minimize bias to the progression-free survival endpoint, disease progression will be based on the assessment of the Central Imaging Reader (CIR). Determination of clinical progression by the Investigator without corresponding CIR confirmation will be documented with the relevant signs and symptoms.
>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.
NCT00198471 ↗ Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment Completed Bausch & Lomb Incorporated Phase 2 2005-07-01 The purpose of this study is to assess the efficacy of intravitreous injections of Vitrase to induce posterior vitreous detachment(PVD) in subjects with moderate to severe non-proliferative diabetic retinopathy.
NCT00198484 ↗ Evaluation of Vitrase as a Spreading Agent Completed Bausch & Lomb Incorporated Phase 3 2004-10-01 The purpose of this study is to determine whether Vitrase (hyaluronidase for injection) is effective as a spreading agent for other injected drugs prior to ocular surgery
>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
Dehydration 5
Healthy 5
Multiple Myeloma 4
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Condition MeSH

Condition MeSH for Hyaluronidase Recombinant Human
Intervention Trials
Diabetes Mellitus 12
Diabetes Mellitus, Type 1 9
Multiple Myeloma 7
Neoplasms, Plasma Cell 7
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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 394
United Kingdom 15
Korea, Republic of 14
France 14
Spain 13
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Trials by US State

Trials by US State for Hyaluronidase Recombinant Human
Location Trials
California 34
New York 21
Texas 19
Washington 17
North Carolina 16
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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 17
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Hyaluronidase Recombinant Human
Clinical Trial Phase Trials
Completed 55
Recruiting 17
Terminated 8
[disabled in preview] 14
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Clinical Trial Sponsors for Hyaluronidase Recombinant Human

Sponsor Name

Sponsor Name for Hyaluronidase Recombinant Human
Sponsor Trials
Halozyme Therapeutics 36
National Cancer Institute (NCI) 7
Baxter Healthcare Corporation 7
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Sponsor Type

Sponsor Type for Hyaluronidase Recombinant Human
Sponsor Trials
Other 71
Industry 69
NIH 9
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