Clinical trial NCT02661477: Clinical and Virological Efficacy of Pegylated Interferon Alpha in the Treatment of Rhinovirus Infection in Patients With Primary Hypogammaglobulinemia: Randomized Controlled Trial
Official title: Clinical and Virological Efficacy of Pegylated Interferon Alpha in the Treatment of Rhinovirus Infection in Patients With Primary Hypogammaglobulinemia: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rhinovirus Infection
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2016-01-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Duration of respiratory symptoms
timeFrame: within 2 months
measure: eradication of rhinovirus from nasal secretion (nasal secretion sample analyzed by rhinovirus PCR)
timeFrame: within 2 months (sample taken daily for 7 days, then weekly for 7 weeks)
measure: time to next respiratory infection
timeFrame: within 2 months
Secondary outcomes:
measure: duration of respiratory symptoms
timeFrame: 2 months
measure: rhinovirus genotype-specific persistence
timeFrame: 2 months
measure: adverse events
timeFrame: 2 months
measure: blood counts
timeFrame: 2 months
measure: alanine aminotransferase
timeFrame: 2 months
measure: creatinine
timeFrame: 2 months
measure: severity of respiratory functions
timeFrame: 2 months
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku university hospital
Study officials:
affiliation: Turku University Hospital
name: Tuomas Jartti, MD
role: PRINCIPAL_INVESTIGATOR
References: