Clinical and Virological Efficacy of Pegylated Interferon Alpha in the Treatment of Rhinovirus Infection in Patients With Primary Hypogammaglobulinemia: Randomized Controlled Trial

Study Overview
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Brief Summary
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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 Group 1: subcutaneous pIFNα2a Group 2: subcutaneous placebo Subjects will have scheduled study visits at 1-week and at 2-month after entry to study. In addition, possible bacterial infections will be treated with antibiotics. Each patient will be followed with weekly nasal surveillance samples for 2 months and a symptom diary. Blood draws take place at study entry, 1-week and 2-month time-points.

Official Title
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Clinical and Virological Efficacy of Pegylated Interferon Alpha in the Treatment of Rhinovirus Infection in Patients With Primary Hypogammaglobulinemia: Randomized Controlled Trial

Conditions
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Rhinovirus Infection

Intervention / Treatment
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* Drug: pegylated interferon alfa 2
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (>18 years), primary hypogammaglobulinemia with regular immunoglobulin replacement therapy, rhinovirus positive from nasal swab, thrombocytes over 90 x109/L, Neutrophiles > 1,5 x109/L written informed consent. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: pegylated interferon + placebo<br>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. | Drug: pegylated interferon alfa 2<br> <br> Other: Placebo<br>* 0,9% natrium chlorine solution<br>|
| Other: placebo + pegylated interferon<br>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 ). | Drug: pegylated interferon alfa 2<br> <br> Other: Placebo<br>* 0,9% natrium chlorine solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of respiratory symptoms | daily questionnaire for 8 weeks | 2 months | 
| rhinovirus genotype-specific persistence |  | 2 months | 
| 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 |