Drugs / hyaluronidase human injection
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT01848990 | Mar 2013 → Feb 2014 | type 1 diabetes mellitus | Halozyme Therapeutics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2014-10-20 | Halozyme Therapeutics | Regulatory Halozyme Receives FDA Approval For Additional Manufacturing Facilities For Hylenex® Recombinant halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration (FDA) has approved new contract manufacturing facilities used in the production of Hylenex® recombinant (hyaluronidase human injection). |
| 2014-06-15 | Halozyme Therapeutics | Results Halozyme Announces Presentation Of Clinical Data At The American Diabetes Association 74th Scientific Sessions halozyme.com ↗
Data reported in the presentation show that the study's primary endpoint of non-inferiority for A1C at six months between the use of Hylenex and the new formulation of Hylenex in comparison to no pre-treatment was met. |
| 2014-03-31 | Halozyme Therapeutics | Results Halozyme Announces that Consistent 1 Trial Of Hylenex® Recombinant Met Primary Endpoint halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the primary endpoint of non-inferiority of A1C levels at six months was met for the CONSISTENT 1 trial. |
| 2013-03-22 | Halozyme Therapeutics | Regulatory Baxter And Halozyme Announce Positive Opinion For HyQvia For Treatment Of Primary And Secondary Immunodeficiencies In The European Union halozyme.com ↗ |
| 2012-08-01 | Halozyme Therapeutics | Regulatory Halozyme Confirms Baxter Has Received A Complete Response Letter For HyQ BLA halozyme.com ↗
After reviewing the data, CDER has confirmed that there is no need for actions against Hylenex or clinical programs in the Hylenex IND. |
| 2012-06-09 | Halozyme Therapeutics | Results Interim Data From Pre-administration of Hylenex in Analog Insulin Pump Therapy Demonstrate Consistent Insulin Action Profile: Data Presented in Late-Breaker Poster at ADA 2012 halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today presented results from a Phase 4 study of Hylenex® recombinant (hyaluronidase human injection) in sensor augmented insulin analog pump (SAP) therapy in patients living with Type 1 diabetes. |
| 2009-10-05 | Halozyme Therapeutics | Results Baxter Announces the Commercial Launch of HYLENEX at ACEP for Use in Pediatric Rehydration halozyme.com ↗
This approach was found to be effective, easy to use and well-tolerated. |
| 2008-01-08 | Halozyme Therapeutics | Results Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex halozyme.com ↗
The authors of this publication concluded from this volunteer subject study that clinically relevant fluid volumes can be rapidly delivered subcutaneously (Sub-Q) with HYLENEX in a well-tolerated manner without the need for an infusion pump. |
All press releases naming this drug 8 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | hyaluronidase human injection | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01848990 ↗ |
| Route | Subcutaneous | “delivered at 150 units (U) through their insulin infusion cannula” NCT01848990 ↗ |