CLINICAL TRIALS PROFILE FOR HYALURONIDASE
✉ Email this page to a colleague
505(b)(2) Clinical Trials for Hyaluronidase
| 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. |
| New Formulation | NCT05388669 ↗ | A Study of Lazertinib and Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer | Not yet recruiting | Janssen Research & Development, LLC | Phase 3 | 2022-08-05 | The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Hyaluronidase
| 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 |
| NCT00198497 ↗ | Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage | Completed | Bausch & Lomb Incorporated | Phase 3 | 1999-06-01 | The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for Hyaluronidase
Condition Name
Clinical Trial Locations for Hyaluronidase
Trials by Country
Clinical Trial Progress for Hyaluronidase
Clinical Trial Phase
Clinical Trial Sponsors for Hyaluronidase
Sponsor Name
