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

Rhinovirus Infection Clinical Trial

— Hypogamma Int1  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02661477
• Other study ID #: T51/2015
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 13, 2016
• Last updated: January 20, 2016
• Start date: May 2016
• Est. completion date: May 2018

Study information

• Verified date: January 2016
• Source: Turku University Hospital
• Contact: Tuomas Jartti, MD
• Phone: +358 2 313 0000
• Email: tuomas.jartti[@]utu.fi
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Common Variable Immunodeficiency
• Infection
• Rhinovirus Infection

Intervention

Drug:
• pegylated interferon alfa 2

Other:
• Placebo
0,9% natrium chlorine solution

Locations

Country	Name	City	State
Finland	Turku university hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of respiratory symptoms		within 2 months	No
Primary	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)	No
Primary	time to next respiratory infection		within 2 months	No
Secondary	duration of respiratory symptoms	daily questionnaire for 8 weeks	2 months	No
Secondary	rhinovirus genotype-specific persistence		2 months	No
Secondary	adverse events	symptom diary	2 months	No
Secondary	blood counts	at time points 0, 1 wk and 2 months	2 months	Yes
Secondary	alanine aminotransferase	at time points 0, 1 wk and 2 months	2 months	Yes
Secondary	creatinine	at time points 0, 1 wk and 2 months	2 months	Yes
Secondary	severity of respiratory functions	daily questionnaire for 8 weeks	2 months	No