Hyaluronidase

Generic Name: Hyaluronidase

Brand Names: Amphadase

Drug Type: Biotech

CAS Number: 9001-54-1

Unique Ingredient Identifier: 8KOG53Z5EM

Background: Hyaluronidase is an enzyme used to improve the absorption and dispersion of parenterally administered fluids, drugs, and contrast agents. The action of hyaluronidase was first described in 1936, and named in 1939. Early research into hyaluronidase identified it as a "spreading factor" which allowed for increased permeability of the connective tissue. Hyaluronidase has been used in surgical settings for at least the past 60 years to improve the diffusion of local anesthetics.

Hyaluronidase was first used in prescription products in the United States on 5 May 2004.

Indication: Hyaluronidase is indicated for subcutaneous fluid administration for hydration, and increasing resorption of radiopaque agents in subcutaneous urography. Hyaluronidase is also indicated by multiple routes to increase the dispersion of other injectable drugs.

Associated Therapies: Parenteral rehydration therapy, Parenteral drug administration, Subcutaneous urography

Clinical Trials

Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus

Phase 2

Completed

Conditions: Diabetes Mellitus, Type 1

Interventions: Drug: Insulin lispro
Drug: recombinant human hyaluronidase PH20
Drug: Insulin glulisine
Drug: Insulin aspart
Drug: Insulin glargine

First Posted Date: 2010-09-02

Last Posted Date: 2019-02-26

Lead Sponsor: Halozyme Therapeutics

Target Recruit Count: 135

Registration Number: NCT01194245

Locations: 🇺🇸
Mercury Street Medical, Butte, Montana, United States
🇺🇸
Mid-America Diabetes Associates, Wichita, Kansas, United States
🇺🇸
Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, United States

and more 16 locations

Efficacy and Time and Resources for Hylenex-facilitated SC Rehydration Versus ORT for Dehydrated Children in the Emergency Department (ED)

Phase 4

Withdrawn

Conditions: Dehydration

Interventions: Other: Oral rehydration fluid
Drug: Isotonic hydration fluid and recombinant human hyaluronidase

First Posted Date: 2010-05-11

Last Posted Date: 2017-05-08

Lead Sponsor: Baxter Healthcare Corporation

Registration Number: NCT01120431

A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs Alone

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Recombinant human hyaluronidase PH20 (rHuPH20)
Drug: Insulin lispro
Drug: Insulin glulisine
Drug: Insulin aspart

First Posted Date: 2009-09-18

Last Posted Date: 2014-07-14

Lead Sponsor: Halozyme Therapeutics

Target Recruit Count: 14

Registration Number: NCT00979875

Locations: 🇺🇸
Profil Institute for Clinical Research, Inc., Chula Vista, California, United States

Liquid Meal Study With Insulin Lispro With/Without Recombinant Human Hyaluronidase PH20 (rHuPH20) and Regular Human Insulin With rHuPH20 to Compare Pharmacokinetics, Postprandial Glycemic Response, and Optimal Insulin Dose in Participants With Type 2 Diabetes Mellitus (T2DM)

Phase 2

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Humalog
Drug: Humulin-R
Drug: Recombinant human hyaluronidase PH20 (rHuPH20)

First Posted Date: 2009-06-09

Last Posted Date: 2014-08-18

Lead Sponsor: Halozyme Therapeutics

Target Recruit Count: 23

Registration Number: NCT00916357

Locations: 🇺🇸
Profil Institute for Clinical Research, Inc., Chula Vista, California, United States

Safety Study of Subcutaneously-Injected Prandial INSULIN-PH20 NP Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes Mellitus

Phase 2

Completed

Conditions: Diabetes Mellitus, Type 1

Interventions: Drug: Insulin Lispro
Drug: regular human insulin
Drug: recombinant human hyaluronidase PH20
Drug: Insulin glargine

First Posted Date: 2009-04-17

Last Posted Date: 2014-09-08

Lead Sponsor: Halozyme Therapeutics

Target Recruit Count: 48

Registration Number: NCT00883558

Locations: 🇺🇸
UNC Diabetes Care Center/Highgate Specialty Center, Durham, North Carolina, United States
🇺🇸
West Olympia Internal Medicine, Olympia, Washington, United States
🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States

and more 5 locations