Human pasteurized C1 esterase inhibitor concentrate (CE1145) in subjects with congenital C1-INH deficiency and acute abdominal or facial HAE attacks.
| DEC-NET Serial number ES496 | |
| Published online | 04/10/2005 16.03.00 |
| Last updated | 02/05/2006 12.12.22 |
| Other protocol ID number | CE1145_3001 |
| Current trial status | Planned (i.e. not yet recruiting participants) |
| Major Disease (ICD9 class) | ANGIONEUROTIC EDEMA NOT ELSEWHERE CLASSIFIED |
| Experimental drug | |
| C1 esterase inhibitor | |
| Gender | Both |
| Age (range) | > 6 years old |
Eligibility criteria | |
| Inclusion criteria | |
| Documented congenital C1-INH deficiency. Acute facial or abdominal HAE attack. | |
| Exclusion criteria | |
| Acquired angioedema. Treatment with any other investigational drug within the last 30 days before study entry. Treatment with any C1-INH concentrate within the previous 7 days. | |
Trial design/methodology | |
| Phase | 3 |
| Kind of study | Efficacy Safety |
| Design | Controlled Randomised Blinded Double blind |
| Purpose of study | |
| To assess the relief of symptoms of acute hereditary angioedema attacks (HAE). | |
| Primary outcomes | |
| Time between start of study medication administration and onset of relief of symptoms from abdominal or facial attack determined by subject.s assessment. | |
| Principal investigator | |
| Name | Mª Concepción López Serrano |
| Institution | Hospital Universitario La Paz |
| Postal address | |
| City | Madrid |
| Country | SPAIN |
| Phone | |
| Fax | |
| mailto:cls01m@saludalia.com | |
| Promoter |
| ZLB Behring GmbH (Industry) |
| Participating countries |
| UNITED KINGDOM |
| SPAIN |
| POLAND |
| CANADA |
| UNITED STATES |
| Participating centres |
| Hospital Universitario La Paz (Madrid) |
| ISRCTN | EudraCT 2004-001186-17 |
