NCT01992276

Assessment of Efficacy of CR8020 and CR6261, Monoclonal Antibodies, Against Influenza Infection

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of CR8020 and CR6261 in Hospitalized Patients With Influenza A Infection

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Crucell Holland BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the rate of decline in quantitative viral load measured in hospitalized patients with Influenza A infection

Detailed description

This is a randomized, placebo-controlled, double-blind phase IIa proof-of-concept study, designed to evaluate the effect of CR8020, CR6261, or placebo in hospitalized patients with influenza A infection that are receiving standard of care. Up to 262 participants will be randomized to receive 30 mg/kg of CR8020, 30 mg/kg of CR6261, or placebo. The study duration will be approximately 117 days for each participant. Prior to enrollment, participants will be screened to assess their eligibility. Eligible participants will be randomized to CR8020, CR6261, or placebo and study drug will be administered on Day 1. Participants will be followed up for 115 days in 9 visits on Days 2 to 8, Day 29, and Day 116 (end of study). After hospital discharge, the remaining follow-up visits will be performed as outpatient visits.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	CR8020	30 mg/kg administered as a single 2-hour intravenous infusion on Day 1
BIOLOGICAL	CR6261	30 mg/kg administered as a single 2-hour intravenous infusion on Day 1
BIOLOGICAL	Placebo	Administered as a single 2-hour intravenous infusion on Day 1

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-10-01
• Completion: 2015-02-01
• First posted: 2013-11-25
• Last updated: 2014-03-04

Locations

68 sites across 12 countries: United States, Australia, Belgium, Brazil, Bulgaria, Canada, France, Germany, Netherlands, South Africa, Spain, Sweden