Hyaluronidase (human recombinant)

Generic Name: Hyaluronidase (human recombinant)

Brand Names: Darzalex Faspro, Herceptin Hylecta, Hylenex, Hyqvia 5 G / 50 Ml Kit, Phesgo, Rituxan Hycela, Vyvgart Hytrulo

Drug Type: Biotech

CAS Number: 757971-58-7

Unique Ingredient Identifier: 743QUY4VD8

Background: A purified preparation of the enzyme recombinant human hyaluronidase. Hyaluronidase (human recombinant) (INN Vorhyaluronidase alfa) is produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). 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 Conditions: Drug Extravasation, Generalized Myasthenia Gravis, Inflammatory Breast Cancer (IBC), Locally Advanced Breast Cancer (LABC), Metastatic Breast Cancer, Primary Immune Deficiency Disorders (PIDD), Primary Immunodeficiency, Secondary humoral immunodeficiency, Stage I Breast Cancer

Associated Therapies: Parenteral rehydration therapy, Improving resorption of radiopaque agents, To increase percutaneous drug absorption therapy

Clinical Trials

Subcutaneous Rehydration Compared to Intravenous Rehydration

Phase 4

Completed

Conditions: Dehydration

Interventions: Drug: recombinant human hyaluronidase

First Posted Date: 2008-10-16

Last Posted Date: 2018-11-07

Lead Sponsor: Halozyme Therapeutics

Target Recruit Count: 148

Registration Number: NCT00773175

Locations: 🇺🇸
Children's Memorial Hospital, Chicago, Illinois, United States
🇺🇸
Rainbow Children's and Babies Hospital, Cleveland, Ohio, United States
🇺🇸
Children's Healthcare of Atlanta, Atlanta, Georgia, United States

and more 22 locations

Study of Subcutaneous Hydration Enabled by Human Recombinant Hyaluronidase (Hylenex)

Phase 4

Completed

Conditions: Healthy

Interventions: Drug: recombinant human hyaluronidase

First Posted Date: 2008-04-11

Last Posted Date: 2018-10-17

Lead Sponsor: Halozyme Therapeutics

Target Recruit Count: 15

Registration Number: NCT00656370

Locations: 🇺🇸
Jasper Clinic, Kalamazoo, Michigan, United States

INFUSE Morphine Study

Phase 3

Completed

Conditions: Pain

Interventions: Drug: Hylenex

First Posted Date: 2008-01-14

Last Posted Date: 2008-01-14

Lead Sponsor: Halozyme Therapeutics

Target Recruit Count: 13

Registration Number: NCT00593281

Locations: 🇺🇸
UCSD Thornton Hospital, San Diego, California, United States
🇺🇸
San Diego Hospice and Palliative Care, San Diego, California, United States

Efficacy of Hylenex in the Treatment of Pain Among Hospice Patients

Not Applicable

Completed

Conditions: Pain Management

Interventions: Drug: Hylenex recombinant , morphine, saline
Other: Saline

First Posted Date: 2007-10-22

Last Posted Date: 2014-02-28

Lead Sponsor: HPC Healthcare, Inc.

Target Recruit Count: 88

Registration Number: NCT00547664

Locations: 🇺🇸
Good Shepherd Hospice, Lakeland, Florida, United States
🇺🇸
LifePath Hospice, Inc., Tampa, Florida, United States
🇺🇸
HPC Healthcare, Inc., Temple Terrace, Florida, United States