Hypogamma Int1: Clinical and Virological Efficacy of Pegylated Interferon Alpha in the Treatment of Rhinovirus Infection in Patients With Primary Hypogammaglobulinemia: Randomized Controlled Trial

Sponsor

Turku University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02661477

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinovirus Infection	Drug: pegylated interferon alfa 2 Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2016

Anticipated Primary Completion Date :

May 1, 2018

Anticipated Study Completion Date :

May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: pegylated interferon + 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.	Drug: pegylated interferon alfa 2 Other: Placebo 0,9% natrium chlorine solution
Other: placebo + pegylated interferon 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 Other: Placebo 0,9% natrium chlorine solution

Arm

Intervention/Treatment

Other: pegylated interferon + 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.

Drug: pegylated interferon alfa 2

Other: Placebo

0,9% natrium chlorine solution

Other: placebo + pegylated interferon

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

Other: Placebo

0,9% natrium chlorine solution

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.