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

NCT02661477 | Unknown Phase 2

• 1 other identifier: T51/2015
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinovirus Infection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• duration of respiratory symptoms

  2 months

• rhinovirus genotype-specific persistence

  2 months

• adverse events

  2 months

• blood counts

  2 months

• alanine aminotransferase

  2 months

Study Arms (2)

pegylated interferon + placebo

OTHER

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

placebo + pegylated interferon

OTHER

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

Interventions

pegylated interferon alfa 2 DRUG

pegylated interferon + placebo; placebo + pegylated interferon

Placebo OTHER

0,9% natrium chlorine solution

pegylated interferon + placebo; placebo + pegylated interferon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku university hospital

Turku, Finland

Location

Study Officials

• Tuomas Jartti, MD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuomas Jartti, MD

CONTACT

+358 2 313 0000; tuomas.jartti@utu.fi

Auli Lammela, MD

CONTACT

+358 2 313 0000; auli.lammela@utu.fi

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 22, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: April 22, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)