Overview
C1 Esterase Inhibitor (Human) is composed of purified endogenous complement component-1 esterase inhibitor (hC1INH) isolated from human plasma. The primary function of endogenous C1INH is to regulate the activation of the complement and contact system pathways. This drug is indicated for prophylaxis and treatment of Hereditary Angioedema (HAE), a human genetic disorder caused by a shortage of C1 inhibitor activity that results in an overreaction of the immune system. The disease is characterized by acute attacks of painful, and in some cases, fatal swelling of several soft tissues or edema, which may last up to five days when untreated.
Background
C1 Esterase Inhibitor (Human) is composed of purified endogenous complement component-1 esterase inhibitor (hC1INH) isolated from human plasma. The primary function of endogenous C1INH is to regulate the activation of the complement and contact system pathways. This drug is indicated for prophylaxis and treatment of Hereditary Angioedema (HAE), a human genetic disorder caused by a shortage of C1 inhibitor activity that results in an overreaction of the immune system. The disease is characterized by acute attacks of painful, and in some cases, fatal swelling of several soft tissues or edema, which may last up to five days when untreated.
Indication
Intravenous and subcutaneous formulations of the human C1-esterase inhibitor are indicated for routine prophylaxis against acute attacks of hereditary angioedema in patients six years of age and older. It is also used to treat these in adult and adolescent patients with hereditary angioedema.
Associated Conditions
- Acute attacks of hereditary angioedema
- Acute attack of hereditary angioedema of the Abdomen
- Acute attack of hereditary angioedema of the Larynx
- Acute attack of hereditary angioedema of the face
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/09 | Phase 2 | Not yet recruiting | |||
2021/08/18 | Phase 2 | Completed | GCS Ramsay Santé pour l'Enseignement et la Recherche | ||
2021/01/06 | Phase 1 | Completed | |||
2016/10/18 | Phase 2 | Completed | |||
2016/08/12 | Phase 3 | Completed | |||
2015/05/06 | Phase 1 | UNKNOWN | |||
2014/05/09 | Phase 1 | Completed | |||
2013/04/30 | Phase 3 | Completed | Technical University of Munich | ||
2010/06/02 | Phase 1 | Completed | Stanley Jordan, MD | ||
2006/02/16 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/15/2011 | ||
Authorised | 6/15/2011 | ||
Authorised | 6/15/2011 | ||
Authorised | 6/15/2011 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CINRYZE C1 esterase inhibitor 500 units powder for solution for injection vial with diluent vial | 177513 | Medicine | A | 4/5/2012 | |
| BERINERT SC Human C1 esterase inhibitor 2000 IU powder for injection glass vial with diluent vial | 292319 | Medicine | A | 7/12/2018 | |
| BERINERT SC Human C1 esterase inhibitor 3000 IU powder for injection glass vial with diluent vial | 292322 | Medicine | A | 7/12/2018 | |
| BERINERT IV human C1 esterase inhibitor 1500 IU powder for injection vial with diluent vial | 281469 | Medicine | A | 9/15/2017 | |
| BERINERT IV human C1 esterase inhibitor 500 IU powder for injection vial with diluent vial | 157279 | Medicine | A | 2/5/2010 |