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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Influenza

In brief

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

Key facts

Study ID

NCT01992276

Run by

Crucell Holland BV

People needed

0

Starts

2013-12-01

Expected to finish

2015-02-01

Last updated by the study team

2014-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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/

Where it is running

• Study site — Stanford, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Tampa, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Maywood, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — Royal Oak, Michigan, United States
• Study site — Troy, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Somers Point, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Dayton, Ohio, United States
• Study site — Wilkes-Barre, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Adelaide, Australia
• Study site — Melbourne, Australia
• Study site — Parkville - Vic, Australia
• Study site — Westmead, Australia
• Study site — Fresno, California, United States

Full record on ClinicalTrials.gov

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