Study Stopped
Due to preliminary efficacy results from an influenza challenge trial
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
3 other identifiers
interventional
N/A
12 countries
68
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2013
Shorter than P25 for phase_2
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedMarch 4, 2014
March 1, 2014
10 months
November 11, 2013
March 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of decline in quantitative viral load
Baseline to Day 8
Secondary Outcomes (10)
Clinical improvement
Baseline to Day 15
Rate of decline in quantitative viral load (subjects not intubated at baseline)
Baseline to Day 8
Rate of decline in quantitative viral load (subjects intubated at baseline)
Baseline to Day 8
Rate of decline in quantitative viral load
Baseline to Day 8
Incidence of adverse events
Baseline to Day 116
- +5 more secondary outcomes
Study Arms (3)
CR8020
EXPERIMENTALInvestigational monoclonal antibody against influenza A viruses
CR6261
EXPERIMENTALInvestigational monoclonal antibody against influenza A viruses
Placebo
PLACEBO COMPARATORDextrose: 5% in water
Interventions
30 mg/kg administered as a single 2-hour intravenous infusion on Day 1
30 mg/kg administered as a single 2-hour intravenous infusion on Day 1
Administered as a single 2-hour intravenous infusion on Day 1
Eligibility Criteria
You may qualify if:
- 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/
You may not qualify if:
- 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/
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Crucell Holland BVlead
- Division of Microbiology and Infectious Diseases (DMID)collaborator
- National Institutes of Health (NIH)collaborator
Study Sites (68)
Unknown Facility
Fresno, California, United States
Unknown Facility
Stanford, California, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Maywood, Illinois, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Royal Oak, Michigan, United States
Unknown Facility
Troy, Michigan, United States
Unknown Facility
Minneapolis, Minnesota, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Hackensack, New Jersey, United States
Unknown Facility
Somers Point, New Jersey, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Dayton, Ohio, United States
Unknown Facility
Wilkes-Barre, Pennsylvania, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Adelaide, Australia
Unknown Facility
Melbourne, Australia
Unknown Facility
Parkville - Vic, Australia
Unknown Facility
Westmead, Australia
Unknown Facility
Brussels, Belgium
Unknown Facility
Edegem, Belgium
Unknown Facility
Ghent, Belgium
Unknown Facility
Leuven, Belgium
Unknown Facility
Belo Horizonte, Brazil
Unknown Facility
Campinas, Brazil
Unknown Facility
Curitiba, Brazil
Unknown Facility
Passo Fundo, Brazil
Unknown Facility
Porto Alegre, Brazil
Unknown Facility
Ribeirão Preto, Brazil
Unknown Facility
São José do Rio Preto, Brazil
Unknown Facility
São Paulo, Brazil
Unknown Facility
Sofia, Bulgaria
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Toronto, Canada
Unknown Facility
Clermont-Ferrand, France
Unknown Facility
Limoges, France
Unknown Facility
Lyon, France
Unknown Facility
Paris, France
Unknown Facility
Rennes, France
Unknown Facility
Saint-Priest-en-Jarez, France
Unknown Facility
Donaustauf, Germany
Unknown Facility
Jena, Germany
Unknown Facility
Leipzig, Germany
Unknown Facility
Potsdam, Germany
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Apeldoorn, Netherlands
Unknown Facility
Leiden, Netherlands
Unknown Facility
Utrecht, Netherlands
Unknown Facility
Benoni, South Africa
Unknown Facility
Durban, South Africa
Unknown Facility
Pretoria Gauteng, South Africa
Unknown Facility
Alicante, Spain
Unknown Facility
Barcelona, Spain
Unknown Facility
Córdoba, Spain
Unknown Facility
Donostia / San Sebastian, Spain
Unknown Facility
Elche, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Santander, Spain
Unknown Facility
Tarragona, Spain
Unknown Facility
Malmo, Sweden
Unknown Facility
Stockholm, Sweden
Unknown Facility
Uppsala, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Crucell Holland BV Clinical Trial
Crucell Holland BV
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2013
First Posted
November 25, 2013
Study Start
December 1, 2013
Primary Completion
October 1, 2014
Study Completion
February 1, 2015
Last Updated
March 4, 2014
Record last verified: 2014-03