Sapphire 63623872FLZ3001 Influenza A

• Research type

  Research Study

• Full title

  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

• IRAS ID

  252501

• Contact name

  Justin Pepperell

• Contact email

  justin.pepperell@tst.nhs.uk

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2017-002156-84

• Clinicaltrials.gov Identifier

  NCT03376321

• Duration of Study in the UK

  0 years, 3 months, 27 days

• Research summary

  This is a phase 3, randomised, double-blind, placebo-controlled, multicentre study in hospitalised patients with Influenza A. Both seasonal and pandemic (spread worldwide) flu are significant causes of illness and death around the world.
  Currently, the annual flu vaccination relies on correctly guessing the disease-causing strains before each season. This means flu is still a large problem within the general population. The purpose of this study is to see if pimodivir (the study drug) in combination with the standard of care treatment is useful for treating patients who have been hospitalised with influenza A. The safety of pimodivir will also be studied. The study is designed so that participants will either receive pimodivir or placebo (non-active) along with standard of care treatment. This will be assigned at random and neither the study doctor nor participant will know which treatment they are receiving. The study is split into 3 parts; Screening/Baseline, where baseline measurements and tests will be undertaken, treatment where the participant will receive the ‘study treatment’ for 5 days and Follow-up which will
  involve 5 visits, the last visit will consist of a safety follow-up visit also. Participants will be recruited to the following age groups: adolescents (13 to 15 years), adults (16 to 65 years) and elderly (>65 to <85 years).

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  18/SC/0572

• Date of REC Opinion

  9 Nov 2018

• REC opinion

  Unfavourable Opinion