A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection who Are at Risk of Developing Complications
- Conditions
- Fluinfluenza A10047438
- Registration Number
- NL-OMON46793
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
• 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 <24 hours is not considered hospitalization as long as a determination of the need for hospitalization has not been made.;• Enrollment and initiation of study drug treatment <=72 hours after onset of influenza symptoms. ;• Subjects 13 to 65 years of age, inclusive must also have at least one of the following: ;- Cardiovascular or cerebrovascular disease (including congenital heart disease, chronic heart failure, coronary artery disease, or stroke; excluding isolated hypertension).;- Chronic lung disease (eg, asthma, chronic obstructive lung disease [COPD] or cystic fibrosis).;- Weakened immune system due to disease or medication (eg, subjects with human immunodeficiency virus [HIV], cancer, or chronic liver or kidney disease, or subjects taking chronic systemic steroids).
• 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the time to resolution of influenza-related symptoms as<br /><br>assessed by the PRO measure Flu-iiQTM. The resolution of<br /><br>influenza-related symptoms is defined as the beginning of the 24 hour period<br /><br>that the 7 primary influenza symptom scores (cough, sore throat, headache,<br /><br>nasal congestion, feeling feverish, body aches and pains, fatigue) are at most<br /><br>mild or at least back to previous level of symptom<br /><br>severity in case the subject reported the symptom as pre-existing.</p><br>
- Secondary Outcome Measures
Name Time Method