| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01756157 | Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks | PHASE2 | COMPLETED | 47 | — | — | Feb 4, 2013 | Sep 13, 2013 | Jun 3, 2021 | 23 | United States, Germany +2 |
| NCT01095510 | CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12 | PHASE2 | COMPLETED | 9 | — | — | Jun 2, 2010 | Apr 17, 2012 | Jun 3, 2021 | 11 | United States, Germany +1 |
Angioedema attack was defined as the participant-reported indication of symptoms or signs such as swelling or pain at any location following a report of no swelling or pain on the previous day. Manifestations of an attack that progress from one site to another, prior to complete resolution, was considered a single attack. Attacks that began to regress and then worsened before complete resolution was also considered one attack. Participants who were dosed but did not have any attacks in the period were assigned a value of zero. The number of attacks was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.
| Arm | Type | Description |
|---|---|---|
| SC CINRYZE with rHuPH20 Dose Level 1 followed by Dose Level 2 | EXPERIMENTAL | SC CINRYZE with rHuPH20 Dose Level 1 twice weekly (every 3 or 4 days) for 8 weeks followed by SC CINRYZE with rHuPH20 Dose Level 2 twice weekly (every 3 or 4 days) for 8 weeks. |
| SC CINRYZE with rHuPH20 Dose Level 2 followed by Dose Level 1 | EXPERIMENTAL | SC CINRYZE with rHuPH20 Dose Level 2 twice weekly (every 3 or 4 days) for 8 weeks followed by SC CINRYZE with rHuPH20 Dose Level 1 twice weekly (every 3 or 4 days) for 8 weeks. |
| 500 U CINRYZE (10-25 kg body weight) | EXPERIMENTAL | Single IV dose of 500 U CINRYZE |
| 1000 U CINRYZE (10-25 kg body weight) | EXPERIMENTAL | Single IV dose of 1000 U CINRYZE |
| 1000 U CINRYZE (>25 kg body weight) | EXPERIMENTAL | Single IV dose of 1000 U CINRYZE |
| 1500 U CINRYZE (>25 kg body weight) | EXPERIMENTAL | Single IV dose of 1500 U CINRYZE |
| Name | Type | Description |
|---|---|---|
| CINRYZE with rHuPH20 | BIOLOGICAL | - |
| CINRYZE | BIOLOGICAL | - |
Inclusion Criteria: * Be ≥12 years of age. * Have a confirmed diagnosis of Hereditary Angioedema. Exclusion Criteria: * Receipt of any C1 inhibitor (C1 INH) therapy or any blood products for treatment or prevention of an angioedema attack within 7 days before the first dose of study drug. * Be re...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Intellia Therapeutics, Inc. | NTLA | 3 | PHASE3 | NTLA-2002, Normal Saline Administration, Biological NTLA-2002 |
| BioCryst Pharmaceuticals, Inc. | BCRX | 2 | PHASE3 | Berotralstat, berotralstat |
| Ionis Pharmaceuticals, Inc. | IONS | 1 | PHASE3 | Donidalorsen |
| KalVista Pharmaceuticals, Inc. | KALV | 1 | PHASE3 | KVD900, Drug: KVD900 |
| Pharvaris N.V. | PHVS | 1 | PHASE2 | deucrictibant |
| BioMarin Pharmaceutical Inc. | BMRN | 1 | PHASE1 | Dose 1 of BMN 331 |
| Astria Therapeutics, Inc. | ATXS | 1 | PHASE2 | STAR-0215 |