Clinical trial NCT01992276: Assessment of Efficacy of CR8020 and CR6261, Monoclonal Antibodies, Against Influenza Infection
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of CR8020 and CR6261 in Hospitalized Patients With Influenza A Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza
Virus
Monoclonal Antibody
Immunization
Treatment
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
Collaborators: name: Division of Microbiology and Infectious Diseases (DMID)
name: National Institutes of Health (NIH)
First posted: 2013-11-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

Participant requires hospitalization/ Each participant or his or her legally acceptable representative must sign an informed consent form/ Participant must be able to start the infusion within 36 hours from the time the screening specimen was collected/ A woman must either be not of childbearing potential or of childbearing potential and agrees to practice two forms of highly effective method of birth control/ A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin \[beta hCG\]) at screening/ A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control/

Exclusion Criteria:

Participant is a female who is pregnant or breastfeeding/ Participant undergoing peritoneal dialysis, hemodialysis or hemofiltration/ Participant has presence of any pre-existing illness that, in the opinion of the investigator, would place the participant at an unreasonably increased risk through participation in this study/ Participant has prior treatment with an experimental mAb; or receipt of IgG within 3 months or on chronic mAb treatment prior to enrollment/ Participant has known or suspected hypersensitivity to any of the CR8020 or CR6261 excipients (sucrose, L-histidine L-histidine monohydrochloride, polysorbate 20)/ Participant received an investigational product (including investigational vaccines) or used an investigational medical device within 60 days before the planned start of treatment, is currently enrolled in an interventional investigational study, or is an employee of the investigational site/

Primary outcomes:
measure: Rate of decline in quantitative viral load
timeFrame: Baseline to Day 8
Secondary outcomes:
measure: Clinical improvement
timeFrame: Baseline to Day 15
measure: Rate of decline in quantitative viral load (subjects not intubated at baseline)
timeFrame: Baseline to Day 8
measure: Rate of decline in quantitative viral load (subjects intubated at baseline)
timeFrame: Baseline to Day 8
measure: Rate of decline in quantitative viral load
timeFrame: Baseline to Day 8
measure: Incidence of adverse events
timeFrame: Baseline to Day 116
measure: Incidence of serious adverse events
timeFrame: Baseline to Day 116
measure: Area under the curve of viral load
timeFrame: Baseline to Day 8
measure: Clinical course for ICU patients
timeFrame: Baseline to Day 8
measure: Length of hospital stay
timeFrame: The duration of hospital stay, an expected average of 7 days
measure: Survival times
timeFrame: Baseline to Day 116
Other outcomes:
Locations:
city: Fresno
country: United States
state: California
city: Stanford
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Tampa
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Hackensack
country: United States
state: New Jersey
city: Somers Point
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Dayton
country: United States
state: Ohio
city: Wilkes Barre
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Adelaide
country: Australia
city: Melbourne
country: Australia
city: Parkville - Vic
country: Australia
city: Westmead
country: Australia
city: Brussel
country: Belgium
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Belo Horizonte
country: Brazil
city: Campinas
country: Brazil
city: Curitiba
country: Brazil
city: Passo Fundo
country: Brazil
city: Porto Alegre
country: Brazil
city: Ribeirão Preto
country: Brazil
city: Sao Jose Do Rio Preto
country: Brazil
city: Sao Paulo
country: Brazil
city: São Paulo
country: Brazil
city: Sofia
country: Bulgaria
city: Toronto
country: Canada
state: Ontario
city: Toronto N/A
country: Canada
city: Toronto
country: Canada
city: Clermont-Ferrand
country: France
city: Limoges
country: France
city: Lyon
country: France
city: Paris
country: France
city: Rennes
country: France
city: St Priest-En-Jarez
country: France
city: Donaustauf
country: Germany
city: Jena
country: Germany
city: Leipzig
country: Germany
city: Potsdam
country: Germany
city: Amsterdam
country: Netherlands
city: Apeldoorn
country: Netherlands
city: Leiden
country: Netherlands
city: Utrecht
country: Netherlands
city: Benoni
country: South Africa
city: Durban
country: South Africa
city: Pretoria Gauteng
country: South Africa
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Córdoba
country: Spain
city: Elche
country: Spain
city: Madrid
country: Spain
city: San Sebastian
country: Spain
city: Santander N/A
country: Spain
city: Tarragona
country: Spain
city: Malmö
country: Sweden
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
Study officials:
affiliation: Crucell Holland BV
name: Crucell Holland BV Clinical Trial
role: STUDY_DIRECTOR
References: