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Pegyloidun interferoni alfan teho ja turvallisuus rinovirusinfektion hoidossa.

Conditions
Rhinovirus infection
MedDRA version: 18.1Level: LLTClassification code 10039107Term: Rhinovirus infection NOSSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Virus Diseases [C02]
Registration Number
EUCTR2015-001072-22-FI
Lead Sponsor
Turku University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Adult patients (>18 years), primary hypogammaglobulinemia with regular immunoglobulin replacement therapy, rhinovirus positive from nasal swab, thrombocytes over 90 x10E9/L Neutrophiles > 1,5 x10E9/L and written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Participation to another study, need for intensive care unit treatment, difficulties to understand national language, pregnancy and breastfeeding, any somatic, psychiatric or social disease or issue which in the opinion of the investigator makes participation in the trial not being in the best interest of the subject.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: The study will investigate the efficacy and safety of subcutaneous interferon alpha -2a to eradicate rhinovirus in patients with primary hypogammaglobulinemia. ;Secondary Objective: Not applicable.;Primary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.
Secondary Outcome Measures
NameTimeMethod
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.
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