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Also known as C1 inhibitor [human], C1 inhibitor (human) [C1 INH], C1 esterase inhibitor (human), C1 Esterase Inhibitor Injection [Cinryze]
CINRYZE · 4 trials · 2 indications
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. |
| SC CINRYZE with rHuPH20 Dose Level 1 | EXPERIMENTAL | Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks |
| SC CINRYZE with rHuPH20 Dose Level 2 | EXPERIMENTAL | Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks |
| IV CINRYZE First, Then SC CINRYZE Dose 1 | EXPERIMENTAL | - |
| IV CINRYZE First, Then SC CINRYZE Dose 2 | EXPERIMENTAL | - |
| 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 | C1 esterase inhibitor (human) |
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 |
| BioCryst Pharmaceuticals, Inc. | BCRX | 2 | PHASE3 | Berotralstat |
| Ionis Pharmaceuticals, Inc. | IONS | 1 | PHASE3 | Donidalorsen |
| Pharvaris N.V. | PHVS | 1 | PHASE2 | Deucrictibant |
| BioMarin Pharmaceutical Inc. | BMRN | 1 | PHASE1 | BMN 331 |
| Astria Therapeutics, Inc. | ATXS | 1 | PHASE2 | STAR-0215 |
CINRYZE is used for hereditary angioedema, a condition marked by recurrent swelling attacks. It has been studied both for treating attacks and, in subcutaneous form with recombinant human hyaluronidase, for preventing angioedema attacks. Clinical trials listed for CINRYZE have enrolled patients with hereditary angioedema, including children under 12 years of age.
CINRYZE is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the company associated with the CINRYZE clinical development program, including the subcutaneous formulation studies that combine CINRYZE with recombinant human hyaluronidase.
CINRYZE is in Phase 2 clinical development for the studies referenced here. All four listed trials are Phase 2 and have completed, with no active trials currently listed. The program includes both intravenous and subcutaneous administration studies in hereditary angioedema.
CINRYZE has been studied in four completed Phase 2 trials: NCT01756157, which tested subcutaneous CINRYZE with recombinant human hyaluronidase for attack prevention; NCT01426763, a safety and pharmacology study of subcutaneous administration; NCT01095510, in children under 12; and NCT01095497, a safety, pharmacokinetics, and pharmacodynamics study. Together these enrolled 94 patients.
The CINRYZE clinical program listed here enrolled a total of 94 patients across four completed Phase 2 trials. Enrollment ranged from 9 patients in the pediatric study NCT01095510 to 47 patients in NCT01756157, the subcutaneous prevention study. The trials were randomized, double-blind, and controlled.