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

• Register: ClinicalTrials.gov
• Last refreshed on: 2 May 2016
• Main ID: NCT02661477
• Date of registration: 13/01/2016
• Prospective Registration: Yes
• Primary sponsor: Turku University Hospital
• Public title: Clinical and Virological Efficacy of Pegylated Interferon Alpha in the Treatment of Rhinovirus Infection in Patients With Primary Hypogammaglobulinemia: Randomized Controlled Trial Hypogamma Int1
• Scientific title: Clinical and Virological Efficacy of Pegylated Interferon Alpha in the Treatment of Rhinovirus Infection in Patients With Primary Hypogammaglobulinemia: Randomized Controlled Trial
• Date of first enrolment: May 2016
• Target sample size: 20
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT02661477
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Finland

Contacts

• Name: Tuomas Jartti, MD
• Affiliation: Turku University Hospital

• Name: Auli Lammela, MD

• Name: Tuomas Jartti, MD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rhinovirus Infection

Intervention(s)

Drug: pegylated interferon alfa 2

Other: Placebo

Primary Outcome(s)

time to next respiratory infection [Time Frame: within 2 months]

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)]

Duration of respiratory symptoms [Time Frame: within 2 months]

Secondary Outcome(s)

blood counts [Time Frame: 2 months]

adverse events [Time Frame: 2 months]

creatinine [Time Frame: 2 months]

rhinovirus genotype-specific persistence [Time Frame: 2 months]

duration of respiratory symptoms [Time Frame: 2 months]

alanine aminotransferase [Time Frame: 2 months]

severity of respiratory functions [Time Frame: 2 months]

Secondary ID(s)

T51/2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors