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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 (Hypogamma Int1)

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ClinicalTrials.gov Identifier: NCT02661477
Recruitment Status : Unknown
Verified April 2016 by Turku University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 22, 2016
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rhinovirus Infection Drug: pegylated interferon alfa 2 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Duration of respiratory symptoms [ Time Frame: within 2 months ]
  2. eradication of rhinovirus from nasal secretion (nasal secretion sample analyzed by rhinovirus PCR) [ Time Frame: within 2 months (sample taken daily for 7 days, then weekly for 7 weeks) ]
  3. time to next respiratory infection [ Time Frame: within 2 months ]

Secondary Outcome Measures :
  1. duration of respiratory symptoms [ Time Frame: 2 months ]
    daily questionnaire for 8 weeks

  2. rhinovirus genotype-specific persistence [ Time Frame: 2 months ]
  3. adverse events [ Time Frame: 2 months ]
    symptom diary

  4. blood counts [ Time Frame: 2 months ]
    at time points 0, 1 wk and 2 months

  5. alanine aminotransferase [ Time Frame: 2 months ]
    at time points 0, 1 wk and 2 months

  6. creatinine [ Time Frame: 2 months ]
    at time points 0, 1 wk and 2 months

  7. severity of respiratory functions [ Time Frame: 2 months ]
    daily questionnaire for 8 weeks



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661477


Contacts
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Contact: Tuomas Jartti, MD +358 2 313 0000 tuomas.jartti@utu.fi
Contact: Auli Lammela, MD +358 2 313 0000 auli.lammela@utu.fi

Locations
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Finland
Turku university hospital
Turku, Finland
Contact: Auli Lammela, MD    +358 2 313 000    auli.lammela@utu.fi   
Sub-Investigator: Auli Lammela, MD         
Principal Investigator: Tuomas Jartti, MD         
Sub-Investigator: Leena Kainulainen, MD         
Sponsors and Collaborators
Turku University Hospital
Investigators
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Principal Investigator: Tuomas Jartti, MD Turku University Hospital
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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT02661477    
Other Study ID Numbers: T51/2015
First Posted: January 22, 2016    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Agammaglobulinemia
Common Variable Immunodeficiency
Blood Protein Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Interferons
Interferon-alpha
Interferon alpha-2
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs