Rhinovirus InfectionPhase 2Hypogamma Int1NCT02661477
Clinical and Virological Efficacy of Pegylated Interferon Alpha in the Treatment of Rhinovirus Infection in Patients With Primary Hypogammaglobulinemia: Randomized Controlled Trial
A Phase 2 study testing pegylated interferon alfa 2 in people with Rhinovirus Infection, run by Turku University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinovirus Infection
- What is being tested?
- pegylated interferon alfa 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- May 2016to May 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Turku university hospital
Turku
Auli Lammela, MD, +358 2 313 000, auli.lammela@utu.fi
Auli Lammela, MD
About this study
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
- Being tested
- pegylated interferon alfa 2, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegylated interferon alfa 2Drug
PlaceboOther
0,9% natrium chlorine solution
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 ). Receives: Drug: pegylated interferon alfa 2; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of respiratory symptoms
Measured: within 2 months
eradication of rhinovirus from nasal secretion (nasal secretion sample analyzed by rhinovirus PCR)
Measured: within 2 months (sample taken daily for 7 days, then weekly for 7 weeks)
time to next respiratory infection
Measured: within 2 months
Secondary outcomes (7)
duration of respiratory symptoms
daily questionnaire for 8 weeks
Measured: 2 months
rhinovirus genotype-specific persistence
Measured: 2 months
adverse events
symptom diary
Measured: 2 months
blood counts
at time points 0, 1 wk and 2 months
Measured: 2 months
alanine aminotransferase
at time points 0, 1 wk and 2 months
Measured: 2 months
creatinine
at time points 0, 1 wk and 2 months
Measured: 2 months
severity of respiratory functions
daily questionnaire for 8 weeks
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinovirus InfectionStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tuomas Jartti, MD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661477
- Sponsor's protocol ID
- T51/2015
- Acronym
- Hypogamma Int1
- Status last verified
- Apr 2016
- First submitted
- 13 Jan 2016
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Virological Efficacy of Pegylated Interferon Alpha in the Treatment of Rhinovirus Infection in Patients With Primary Hypogammaglobulinemia: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02661477
- Acronym / sponsor ID
- Hypogamma Int1 / T51/2015
- Conditions
- Rhinovirus Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- May 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pegylated interferon + placebo | Other | Drug: pegylated interferon alfa 2, Other: PlaceboPatients 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. |
| placebo + pegylated interferon | Other | Drug: pegylated interferon alfa 2, Other: PlaceboPatients 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 ). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pegylated interferon alfa 2 | Drug | pegylated interferon + placebo, placebo + pegylated interferon |
| Placebo0,9% natrium chlorine solution | Other | pegylated interferon + placebo, placebo + pegylated interferon |
Primary outcome
Duration of respiratory symptoms
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)
time to next respiratory infection
Time frame: within 2 months
7 secondary outcomes
duration of respiratory symptoms
Time frame: 2 months
rhinovirus genotype-specific persistence
Time frame: 2 months
adverse events
Time frame: 2 months
blood counts
Time frame: 2 months
alanine aminotransferase
Time frame: 2 months
creatinine
Time frame: 2 months
severity of respiratory functions
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuomas Jartti, MD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pegylated interferon alfa 2 in people with Rhinovirus Infection, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuomas Jartti, MD (+358 2 313 0000, tuomas.jartti@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of respiratory symptoms (time frame: within 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2016.