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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

NCT02661477 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-04-22

No results posted yet for this study

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.

Conditions

  • Rhinovirus Infection

Interventions

DRUG

pegylated interferon alfa 2

OTHER

Placebo

0,9% natrium chlorine solution

Sponsors & Collaborators

  • Turku University Hospital

    lead OTHER_GOV

Principal Investigators

  • Tuomas Jartti, MD · Turku University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02661477 on ClinicalTrials.gov