Phase II Trial With Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense

PHASE2CompletedINTERVENTIONAL
Enrollment

151

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Allergic Rhinoconjunctivitis
Interventions
BIOLOGICAL

Allergovac Depot

Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

BIOLOGICAL

Allergovac Depot

Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

BIOLOGICAL

Allergovac Depot

Increasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

BIOLOGICAL

Allergovac Depot

Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

BIOLOGICAL

Allergovac Depot

Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

BIOLOGICAL

Placebo

Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.

Trial Locations (10)

28007

Hospital Universitario Gregorio Marañón, Madrid

28034

Hospital Universitario Ramón y Cajal, Madrid

28046

Hospital Universitario La Paz, Madrid

28222

Hospital Universitario Puerta de Hierro, Madrid

45600

Hospital Ntra. Sra. del Prado, Talavera de la Reina

3000-075

Hospital da Universidade de Coimbra, Coimbra

4200-319

Centro Hospitalar de S. João, Porto

4460-188

Instituto CUF Porto, Senhora da Hora

2910-446

Centro Hospitalar de Setúbal - Hospital de São Bernardo, Setúbal

4434-502

Centro Hospitalar Gaia/Espinho, Vila Nova de Gaia

All Listed Sponsors
lead

Roxall Medicina España S.A

INDUSTRY

NCT01567306 - Phase II Trial With Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense | Biotech Hunter | Biotech Hunter