The primary objective is to evaluate the pharmacokinetic (PK) parameters of JNJ-63623872 in combination with oseltamivir in elderly subjects (aged 65 to *85 years) compared to adults (aged 18 to *64 years) with influenza A infection.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to evaluate the pharmacokinetic (PK) parameters of
JNJ-63623872 in
combination with oseltamivir in elderly subjects (aged 65 to *85 years)
compared to adults (aged 18 to *64 years) with influenza A infection.
Secondary outcome
Secondary objectives include the assessment of the following parameters in the
JNJ-63623872
treatment arm compared to the control arm:
1. Safety and tolerability.
2. The time to influenza viral negativity based on quantitative reverse
transcription polymerase
chain reaction (qRT-PCR) and/or viral culture from nasal mid-turbinate (MT)
swabs and, if
applicable, based on PCR-based rapid molecular testing from nasal MT swabs.
3. Viral load over time and rate of decline in viral load during treatment as
measured by qRTPCR
and/or by viral culture.
4. Area under the curve (AUC) of viral load as measured by qRT-PCR and/or by
viral culture.
5. Disease status and incidence of complications associated with influenza
after the start of study
treatment, and disease progression:
o bacterial pneumonia (culture confirmed where possible),
o other bacterial superinfections,
o respiratory failure,
o pulmonary disease (eg, asthma, chronic obstructive pulmonary disease [COPD]),
o cardiovascular and cerebrovascular disease (eg, myocardial infarction,
congestive
heart failure [CHF], arrhythmia, stroke).
6. Change in duration and severity of clinical symptoms as measured by the
Flu-PRO.
7. Time to improvement of vital signs.
8. Time to improvement of respiratory status.
9. Emergence of drug resistance as detected by genotype or phenotype.
10. Time to return to premorbid functional status.
11. Time to hospital discharge.
12. Hierarchal ordinal scale for clinical outcome
Background summary
Both seasonal and pandemic influenza are a significant cause of morbidity and
mortality worldwide. For example, the 2009 H1N1 influenza pandemic in the
United States was responsible for an estimated 60.8 million cases, 274,000
hospitalizations, and over 12,400 deaths.8 Because the efficacy of the current
annual hemagglutinin-based or modified live influenza virus vaccines depends on
accurately predicting the viral strains prior to each influenza season or
pandemic, there exists an unmet need for new antiviral agents that are broadly
effective.
Study objective
The primary objective is to evaluate the pharmacokinetic (PK) parameters of
JNJ-63623872 in combination with oseltamivir in elderly subjects (aged 65 to
*85 years) compared to adults (aged 18 to *64 years) with influenza A
infection.
Study design
This is a randomized, double-blind, placebo-controlled, multicenter Phase 2
study to evaluate the effect of JNJ-63623872 600 mg twice daily (bid) versus
(vs.) placebo, both in combination with oseltamivir 75 mg bid in adult and
elderly hospitalized subjects with influenza A
infection. Up to 90 subjects in total will be enrolled in this study.
Recruitment will be limited to a single northern hemisphere influenza season.
The study will consist of a screening/baseline visit, a double-blind treatment
period of 7 days, and a follow-up period of 21 days. The entire study duration
for each subject will be 28 days with study assessments daily during the
treatment period, and on Days 10, 14, and 28 of the follow-up period. The study
is considered complete with the completion of the last study assessment for the
last subject participating in the study.
Intervention
Subjects who meet all eligibility criteria will be randomized in a 2:1 ratio to
receive 1 of the following 2 treatments:
* JNJ-63623872 600 mg bid + oseltamivir 75 mg bid; OR
* JNJ-63623872 placebo bid + oseltamivir 75 mg bid
All study drugs will be taken orally.
Study burden and risks
Admission to the hospital is a requirement for participation, but is already
part of the proposed standard of care. If participant is able to leave the
hospital early, daily follow-up by phone by the investigator in the first week.
Every call lasts about 15 minutes.
All drugs can cause side effects. Since JNJ-63623872 has only been given to a
small number of people, not all possible side effects and risks related to
JNJ-63623872 are known. Problems that are not expected may arise and they may
be life-threatening. If you have any side effects or problems during your
participation in this study, you should let your study doctor know right away.
All medications might have adverse events, known or unknown. In general,
JNJ-63623872 has been well tolerated so far. Known adverse events are headache,
diarrhoea, higher blood values of liver enzymes, lower phosphate levels in the
blood. It is possible you might experience these effects. Please tell you
investigator immediately if this is the case. This is regardless of the fact if
you think this is related to the treatment or not.
Advantages
JNJ-63623872 may have a possible positive effect on the treatment of your flu,
or making the syproms easier. It is however not sure you will experience a
personal benefit. Your flu symptoms can remain the same or worsen.
The information which will be collected by this research can contribute to more
knowledge about the use of JNJ-63623872 and to further developemtn for a new
treatment against flu.
Disadvantages
You might experience a disadvantage because of the extra time commitment you
will make during participation, additional visits and/or assessments. Please
respect the guidelines of the trial. You might experience adverse events from
JNJ-63623872 or from the planned assessments.
Bond Park - Graaf Engelbertlaan 75
Breda 4837
NL
Bond Park - Graaf Engelbertlaan 75
Breda 4837
NL
Listed location countries
Age
Inclusion criteria
- Participant requires hospitalization to treat influenza infection and/or to treat complications of influenza infection
- Participant tested positive for influenza A infection within 1 day of signing of the informed consent form (ICF)/assent form using a polymerase chain reaction (PCR)-based rapid molecular diagnostic assay
- Participants must be capable of swallowing study medication tablets and capsules
- Each participant (or their legally acceptable representative) must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
- Participant must be willing and able to adhere to the prohibitions and restrictions specified in the protocol
Exclusion criteria
- Participant received more than 3 doses of the influenza antiviral
medication oseltamivir, zanamivir, or peramivir since the start of the influenza symptoms, or ribavirin within 6 months prior to Screening
- Participant is unwilling to undergo regular nasal Mid-turbinate (MT) swabs or has any physical abnormality which limits the ability to collect regular nasal specimens
- Participant is immunocompromised, whether due to underlying medical condition (example, malignancy) or medical therapy (example, medications, chemotherapy, radiation, post-transplant)
- Participant is undergoing peritoneal dialysis, hemodialysis, or hemofiltration
- Participant has an estimated glomerular filtration rate (eGFR) less than or equal to (<=)30 milliliter (mL)/minute (min)/1.73 meter^2 (m^2) according to the Modification of Diet in Renal Disease (MDRD) equation, assessed at Screening or based on the most recent clinically relevant creatinine value if available
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-003002-17-NL |
| ClinicalTrials.gov | NCT02532283;CR107746 |
| CCMO | NL55154.078.15 |