Dose-response Study With Subcutaneous Immunotherapy of an Standardized Dermatophagoides Pteronyssinus (DPT) Extract

Summary

As part of the registration plan of our products and after performing a Phase I study the present trial has been designed to compare the efficacy of 5 different doses of subcutaneous immunotherapy in depot presentation.

Conditions

• Allergic Rhinoconjunctivitis

Interventions

BIOLOGICAL

Allergovac depot

Depot sterile suspension fpor subcutaneous injection Increasing concentrations to reach the following maintenance doses: Group 1: 0.25 SPT

BIOLOGICAL

Allergovac depot

Depot sterile suspension for subcutaneous injection. Increasing concentrations to reach the following maintenance doses: Group 2: 0.5 SPT

BIOLOGICAL

Allergovac depot

Depot sterile suspension for subcutaneous injection. Increasing concentrations to reach the following maintenance doses: Group 3: 1 SPT

BIOLOGICAL

Allergovac depot

depot sterile suspension for subcutaneous injection Increasing concentrations to reach the following maintenance doses: Group 4: 2 SPT

BIOLOGICAL

Allergovac depot

Depot sterile suspension for subcutaneous injection. Increasing concentrations to reach the following maintenance doses: Group 5: 4 SPT

BIOLOGICAL

Allergovac depot

Sterile suspension for subcutaneous injection. Same number of administration as the active groups

Sponsors & Collaborators

• Roxall Medicina España S.A

  lead INDUSTRY

Principal Investigators

• Fernando Rodríguez, MD · Hospital Universitario Marqués de Valdecilla

• Ramón Lleonart, MD · Hospital Universitario Marqués de Valdecilla

• Albert Roger, MD · Germans Trias i Pujol Hospital

• Dolores Hernández, MD · Hospital Universitario La Fe

• Carmen Vidal, MD · Complejo Hospitalario Universitario de Santiago

• Juan A Pagán, MD · Hospital Virgen de la Arrixaca

• Carmen Marcos, MD · Hospital Xeral de Vigo

• Jose A Navarro, MD · Hospital Donostia

• Victoria Moreno, MD · Hospital Blanca Paloma

• Luis A Navarro, MD · Hospital Luis Alcañiz

• María I Peña, MD · Hospital Vega Baja

• Marta Alvariño, MD · Hospital de Manises

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-05-31

Primary Completion

2013-05-31

Completion

2013-05-31

Countries

• Spain

Study Locations