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

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.

Study Overview

• Status: Unknown
• Conditions: Rhinovirus Infection
• Intervention / Treatment: Drug: pegylated interferon alfa 2; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Tuomas Jartti, MD; Phone Number: +358 2 313 0000; Email: tuomas.jartti@utu.fi
• Study Contact Backup: Name: Auli Lammela, MD; Phone Number: +358 2 313 0000; Email: auli.lammela@utu.fi

Study Locations

• Finland
  • Turku, Finland
    • Turku University Hospital
    • Contact: Auli Lammela, MD; Phone Number: +358 2 313 000; Email: auli.lammela@utu.fi
    • Sub-Investigator: Auli Lammela, MD
    • Principal Investigator: Tuomas Jartti, MD
    • Sub-Investigator: Leena Kainulainen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Investigators: Principal Investigator: Tuomas Jartti, MD, Turku University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: January 20, 2016
• First Posted (Estimate): January 22, 2016

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: April 21, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immunologic Deficiency Syndromes; Immune System Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Disease Attributes; Hematologic Diseases; Blood Protein Disorders; Infections; Communicable Diseases; Agammaglobulinemia; Common Variable Immunodeficiency; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Interferons; Interferon-alpha; Interferon alpha-2
• Other Study ID Numbers: T51/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO