A randomized, placebo-controlled, double-blind Phase III study of the efficacy and safety of recombinant human C1 inhibitor for the treatment of acute attacks in patients with hereditary angioedema (HAE).
| DEC-NET Serial number ES442 | |
| Published online | 08/07/2005 9.21.00 |
| Last updated | 24/04/2006 8.44.26 |
| Other protocol ID number | C1 1304-01 |
| Current trial status | Open (actively recruiting new participants) |
| Major Disease (ICD9 class) | ANGIONEUROTIC EDEMA NOT ELSEWHERE CLASSIFIED |
| Experimental drug | |
| Recombinant C1 inhibitor | |
| Gender | Both |
| Age (range) | > 16 years old |
Eligibility criteria | |
| Inclusion criteria | |
| Hereditary angioedema with plasma level of functional C1 inhibitor (C1INH) of less than 50% of normal levels, with a severe attack of angioedema. | |
| Exclusion criteria | |
| Main exclusion criterion: Life-threatening attack requiring immediate emergency procedures. | |
Trial design/methodology | |
| Phase | 3 |
| Kind of study | Efficacy Safety |
| Design | Controlled Randomised Blinded Double blind |
| Purpose of study | |
| To demonstrate the efficacy of recombinant C1 inhibitor (r-C1INH) in the treatment of acute attacks in patients with hereditary angioedema, and to assess its safety and tolerability. | |
| Primary outcomes | |
| Time until the beginning of the relive based on the punctuation of the patient in an analog visual scale. | |
| Secondary outcomes | |
| Time until the resolution of clinical symptoms based on the punctuation of the patient in an analog visual scale. | |
| Principal investigator | |
| Name | Mar Guilarte |
| Institution | Hospital Universitari Vall d'Hebron (S. de Alergia) |
| Postal address | Paseo Vall d'Hebron, 119-129 |
| City | Barcelona-08035 |
| Country | SPAIN |
| Phone | 932746203 ext 4035 |
| Fax | |
| Promoter |
| Lab. Dr. Esteve S.A. (Industry) |
| Participating countries |
| SPAIN |
| UNITED KINGDOM |
| ITALY |
| Participating centres |
| Hosp. Virgen del Rocío (Sevilla) |
| Hosp. Universitari Vall d'Hebron (Barcelona) |
| Hosp. La Fe (Valencia) |
| Hosp. Gregorio Marañón (Madrid) |
| ISRCTN | EudraCT 2004-004282-15 |
