NL-OMON48779
Completed
Phase 3
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection - Janssen Influenza A_3001
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Janssen-Cilag
- Enrollment
- 26
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility 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.
- •\* Tested positive for influenza A infection after the onset of symptoms using a
- •polymerase chain reaction (PCR)\-based or other rapid molecular diagnostic
- •\* Requires hospitalization to treat influenza infection and/or to treat
- •complications of influenza infection (eg, radiological signs of lower
- •respiratory tract disease, septic shock, central nervous system \[CNS]
- •involvement, myositis, rhabdomyolysis, acute exacerbation of chronic kidney
- •disease, severe dehydration, myocarditis, pericarditis, ischemic heart disease,
Exclusion Criteria
- •\* Received more than 3 doses of influenza antiviral medication (eg, oseltamivir
- •\[OST] or zanamivir), or any dose of ribavirin within 2 weeks, prior to first
- •study drug intake. Received intravenous (IV) peramivir more than one 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
- •\* 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
Outcomes
Primary Outcomes
Not specified
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