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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02844842
Other study ID # BIA-ALE-2016-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 23, 2016
Est. completion date September 6, 2018

Study information

Verified date January 2019
Source Roxall Medicina España S.A
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational prospective study to assess the tolerability and safety of treatment of SCIT Allergovac Poliplus polymerized in depot presentation. The study drug will be administered either by a 1 day Schedule or by a rapid Schedule (3 increasing weekly doses at initiation period till maintenance dose is reached) The study population is both: adult and child, polysensitized to at least 2 allergen sources with rhinitis or allergic rhinoconjunctivitis. Patients may also present a concomitant mild or moderate asthma.

The assignment of a patient to a particular therapeutic strategy will not be decided in advanced by a trial protocol but will be determined by routine clinical practice. The decision of the investigator to prescribe a particular treatment will be clearly dissociated from the decision to include the patient in the study. The patients will not suffer any intervention, whether diagnostic or monitoring, other than the usual in clinical practice.


Recruitment information / eligibility

Status Completed
Enrollment 152
Est. completion date September 6, 2018
Est. primary completion date September 6, 2018
Accepts healthy volunteers No
Gender All
Age group 5 Years to 60 Years
Eligibility Inclusion Criteria:

1. Patients aged between 5 and 60 years who present rhinitis or allergic rhinoconjunctivitis caused by IgE-mediated sensitization to more than one allergen source with or without mild / moderate asthma.

2. Patients eligible for immunotherapy treatment with Allergovac Poliplus according to investigator criteria.

3. Patients must provide written informed consent. It is the case of children , the legal representative or tutor of the child must sign the inform consent form.

Exclusion Criteria:

1. Patients that according to the investigator criteria may present difficulties for understanding the patient information sheet, completing the questionnaires and self-administered scales.

2. Patients that according to the investigator may present difficulties to complete the patient diary.

3. Patients who are participating in another clinical trial or observational study.

Study Design


Intervention

Biological:
Allergovac Poliplus


Locations

Country Name City State
Spain C.H.U A Coruña A Coruna
Spain Hopsital de Vinalopó Elche
Spain Clínica Dr. Arias Irigoyen Huelva
Spain Clínica Dra. Victoria Moreno Huelva
Spain Hospital de Lugo Lugo
Spain Clínica de Asma y Alergia Dres. Ojeda Madrid
Spain Hospital Principe de Asturias Madrid
Spain Hospital Puerta de Hierro Madrid
Spain Hospital de Onteniente Onteniente
Spain Hospital de Tórax Santa Cruz de Tenerife
Spain Hospital Ntra. Sra de la Candelaria Santa Cruz de Tenerife
Spain Hospital Joan XXIII Tarragona
Spain Hospital de Terrassa Terrassa
Spain Hospital de Manises Valencia
Spain Hospital de Xátiva Xátiva

Sponsors (1)

Lead Sponsor Collaborator
Roxall Medicina España S.A

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number and severity of adverse drug reactions From patient ICF signature till 1 week after last administered dose
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