Influenza A Infection MedDRA version: 20.1 Level: LLT Classification code 10022002 Term: Influenza A virus infection System Organ Class: 100000004862
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female, 13 to 85 years of age, inclusive. Note: Adolescent subjects (13-17 years) will be enrolled in selected countries and study sites consistent with local regulations. • Present to the clinic with symptoms suggestive of a diagnosis of acute influenza and have at least 1 respiratory symptom and at least 1 systemic symptom, both scored as at least “moderate” if the symptom did not pre-exist before influenza onset, or scored worse than usual if the symptom pre existed. as determined by subject’s ratings on Module 1 of the Flu-iiQTM and the Pre-existing Symptom Questionnaire in the ePRO device. Symptoms must include the following by category: respiratory symptoms: cough, sore throat, nasal congestion; systemic symptoms: headache, body aches or pain, feverishness, fatigue. • Tested positive for influenza A infection after the onset of symptoms, using a rapid influenza diagnostic test (RIDT) or, if available, a PCR-based molecular diagnostic assay. • Not be in need of hospitalized medical care at screening. Emergency room or hospital observation status for =65 years) yes F.1.3.1 Number of subjects for this age range 324
Exclusion criteria
Exclusion criteria: • Received more than 1 dose of influenza antiviral medication (eg, oseltamivir [OST] or zanamivir), or any dose of ribavirin within 2 weeks, prior to first study drug intake, or received intravenous (IV) peramivir more than 1 day prior to screening. • Unwilling to undergo regular nasal mid-turbinate (MT) swabs or has any physical abnormality which limits the ability to collect regular nasal MT specimens. • Unstable angina pectoris or myocardial infarction within 30 days prior to screening (inclusive). • Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia, or risk factors for Torsade de Pointes syndrome. • Known severe hepatic impairment (Child Pugh C cirrhosis) or chronic hepatitis C infection undergoing hepatitis C antiviral . • Severely immunocompromised in the opinion of the investigator (eg, known cluster of differentiation 4+ [CD4+] count <200 cells/mm3, absolute neutrophil count <750/mm3, first course of chemotherapy completed within 2 weeks prior to screening, history of stem cell transplant within 1 year prior to screening, history of a lung transplant).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate superiority of pimodivir (Pi) in combination with standard-of-care (SOC) treatment (tmt) compared to placebo in combination with SOC treatment, with respect to the time to resolution of influenza-related symptoms.;Secondary Objective: Compare Pi in combination with SOC treatment to placebo in combination with SOC tmt (Pi+SOC_Pl+SOC) re.: • Safety, tolerability • Time to return to daily activities as assessed by the subject • Time to resolution of fever • All-cause mortality Evaluate superiority of Pi+SOC vs.Pl+SOC with respect to: • Hospital admission rate 28 days after initiation of tmt • Incidence of complications associated with influenza after start of study tmt • Time to viral negativity by quantitative real time polymerase chain reaction and viral culture Assess PK of Pi and explore PK/PD relationships of Pi for efficacy and safety Investigate: • Acceptability (taste, swallowability) of Pi formulation in adolescents • Time to resolution of influenza-related symptoms • Emerge of viral resistance against Pi detected by genotyping and/or phenotyping.;Primary end point(s): The primary endpoint is the time to resolution of influenza-related symptoms as assessed by the PRO measure Flu-iiQTM. The resolution of influenza-related symptoms is defined as the beginning of the 24 hour period that the 7 primary influenza symptom scores (cough, sore throat, headache, nasal congestion, feeling feverish, body aches and pains, fatigue) are at most mild or at least back to previous level of symptom severity in case the subject reported the symptom as pre-existing.;Timepoint(s) of evaluation of this end point: Day 28+/-1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Safety and tolerability based on assessment of adverse events (AEs), clinical laboratory assessments, 12-lead electrocardiograms (ECGs) and vital signs. 2. The hospital admission rate 28 days after treatment initiation. 3. Incidence of complications associated with influenza after the start of study treatment. A blinded Adjudication Committee (AC) will be established to adjudicate AEs on predefined criteria for complications (pulmonary versus extrapulmonary, major versus minor, as well as infectious versus non-infectious complications). The AC will receive data on AEs, including medical assessments (eg chest X-ray results, lab results) and concomitant therapy of cases selected from the AEs. Details will be provided in an AC charter. 4. Time to resolution of each of the 10 individual influenza-related symptoms as assessed by the PRO measure Flu-iiQTM. The resolution of each influenza-related symptom is defined as the beginning of the 24-hour period when the influenza symptom score is at most mild or at least back to the previous level of symptom severity in case the subject reported the symptom as pre-existing. 5. Time to return to daily activities as assessed by the subject. 6. Time to resolution of fever. Resolution of fever is defined as a body temperature <37.0°C during a period of 24 hours without the use of antipyretics. 7. All-cause mortality. 8. PK parameters of pimodivir (ie, plasma concentration just prior to the beginning or at the end of a dosing interval [Ctrough], Cmax, tmax, and AUC12h), as determined by population PK analysis. 9. The acceptability of the pimodivir formulation in adolescents, as measured by a taste and swallowability questionnaire. 10. The emergence of viral resistance against pimodivir detected by genotyping and/or phenotyping. 11. Time to viral negativity by qRT-PCR and viral culture. 12. Viral load over time by qRT-PCR and viral culture.;Timepoint(s) of evaluation of this end point: 1.-7. Day | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, Estonia, France, Germany, Hungary, India, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Peru, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Vietnam
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed