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Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)

NCT01489020 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-05-06

Study results available
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Summary

Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic diseases the aim of this study was to assess safety and tolerability of 3 different subcutaneous immunotherapy dose escalations in patients allergic to Dermatophagoides pteronyssinus.

Conditions

  • Allergic Rhinoconjunctivitis

Interventions

BIOLOGICAL

subcutaneous immunotherapy with DPT extract

Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)

BIOLOGICAL

Subcutaneous depot placebo

Increasing doses of subcutaneous depot placebo in three different scales

Sponsors & Collaborators

  • Roxall Medicina España S.A

    lead INDUSTRY

Principal Investigators

  • Mª Dolores Hernández, MD · Hospital Universitario La Fe

  • Ignacio Antépara, MD · Hospital de Basurto

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
2011-01-31
Primary Completion
2011-07-31
Completion
2011-08-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01489020 on ClinicalTrials.gov