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

Phase 2

• Conditions: Rhinovirus Infection
• Interventions: Drug: pegylated interferon alfa 2; Other: Placebo

• Registration Number: NCT02661477
• Lead Sponsor: Turku University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-13
• Study First Submitted QC: 2016-01-20
• Study First Posted: 2016-01-22
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-21
• Last Update Posted: 2016-04-22
• Study Start: 2016-05
• Primary Completion: 2018-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
pegylated interferon + placebo	pegylated interferon alfa 2	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.
pegylated interferon + placebo	Placebo	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	pegylated interferon alfa 2	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 ).
placebo + pegylated interferon	Placebo	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 ).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
adverse events	2 months	symptom diary
duration of respiratory symptoms	2 months	daily questionnaire for 8 weeks
rhinovirus genotype-specific persistence	2 months
alanine aminotransferase	2 months	at time points 0, 1 wk and 2 months
blood counts	2 months	at time points 0, 1 wk and 2 months
creatinine	2 months	at time points 0, 1 wk and 2 months
severity of respiratory functions	2 months	daily questionnaire for 8 weeks

Trial Locations

Locations (1)

Turku university hospital; 🇫🇮 Turku, Finland