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Pegyloidun interferoni alfan teho ja turvallisuus rinovirusinfektion hoidossa.

Clinical and virological efficacy of pegylated interferon alpha in the treatment of rhinovirus infection in patients with primary hypogammaglobulinemia: randomized controlled trial - HypogammaInt1

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-001072-22-FI
Enrollment
20
Registered
2016-01-05
Start date
2016-01-26
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinovirus infection MedDRA version: 18.1 Level: LLT Classification code 10039107 Term: Rhinovirus infection NOS System Organ Class: 100000004862

Interventions

Trade Name: Pegasys Pharmaceutical Form: Injection INN or Proposed INN: PEGINTERFERON ALFA-2A CAS Number: 198153-51-4 Concentration unit: µg microgram(s) Concentration type: equal Concentration number

Sponsors

Turku University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.

Countries

Finland

Contacts

Public ContactTurku University Hospital

Turku University Hospital

auli.lammela@utu.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026