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The study will investigate the efficacy and safety of subcutaneous interferon alpha -2a to eradicate rhinovirus in patients with primary hypogammaglobulinemia. Patients with hypogammaglobulinemia have persistent rhinovirus infections. Rhinovirus may worsen pulmonary complications. Pegylated interferon alpha with ribavirin appear to effectively clear persistent rhinovirus infections in hypogammaglobulinemia patients.
Patients with primary hypogammaglobulinemia and confirmed respiratory rhinovirus infection will be randomly assigned in a double-blind fashion to receive either
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pegylated interferon + placebo | Other | Patients with primary hypogammaglobulinemia and confirmed respiratory rhinovirus infection will receive subcutaneous pIFNα2a (pegylated interferon alfa 2, Pegasys, 180 ug s.c. injection once a week, two times ). Washout period is 8 weeks. When the same patient gets next rhinovirus infection, he/she will receive subcutaneous placebo (0,9% NaCl) injection once a week, two times. |
|
| placebo + pegylated interferon | Other | Patients with primary hypogammaglobulinemia and confirmed respiratory rhinovirus infection will receive will receivesubcutaneous placebo(0,9% NaCl) injection once a week, two times. Washout period is 8 weeks. When the same patient gets next rhinovirus infection, he/she will subcutaneous pIFNα2a (pegylated interferon alfa 2, Pegasys, 180 ug s.c. injection once a week, two times ). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegylated interferon alfa 2 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of respiratory symptoms | within 2 months | |
| eradication of rhinovirus from nasal secretion (nasal secretion sample analyzed by rhinovirus PCR) | within 2 months (sample taken daily for 7 days, then weekly for 7 weeks) | |
| time to next respiratory infection | within 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| duration of respiratory symptoms | daily questionnaire for 8 weeks | 2 months |
| rhinovirus genotype-specific persistence | 2 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tuomas Jartti, MD | Contact | +358 2 313 0000 | tuomas.jartti@utu.fi | |
| Auli Lammela, MD | Contact | +358 2 313 0000 | auli.lammela@utu.fi |
| Name | Affiliation | Role |
|---|---|---|
| Tuomas Jartti, MD | Turku University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku university hospital | Turku | Finland |
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| Other |
0,9% natrium chlorine solution |
|
| adverse events |
symptom diary |
| 2 months |
| blood counts | at time points 0, 1 wk and 2 months | 2 months |
| alanine aminotransferase | at time points 0, 1 wk and 2 months | 2 months |
| creatinine | at time points 0, 1 wk and 2 months | 2 months |
| severity of respiratory functions | daily questionnaire for 8 weeks | 2 months |