A Phase 2 interventional study of CR8020 and CR6261 in Influenza, sponsored by Crucell Holland BV. Withdrawn at 70 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-04.
Sponsored by Crucell Holland BV · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the rate of decline in quantitative viral load measured in hospitalized patients with Influenza A infection
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
Browse Influenza, Human studies →Crucell Holland BV is the lead sponsor of 35 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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/
Investigational monoclonal antibody against influenza A viruses
Biological: CR8020
Investigational monoclonal antibody against influenza A viruses
Biological: CR6261
Dextrose: 5% in water
Biological: Placebo
30 mg/kg administered as a single 2-hour intravenous infusion on Day 1
Also known as: CR8020 30 mg/kg by iv infusion
30 mg/kg administered as a single 2-hour intravenous infusion on Day 1
Also known as: CR6261 30 mg/kg by iv infusion
Administered as a single 2-hour intravenous infusion on Day 1
Also known as: Placebo by iv infusion
Rate of decline in quantitative viral load
Time frame: Baseline to Day 8
Clinical improvement
Daily influenza symptoms and signs: Four domains from the Influenza Intensity and Impact Questionnaire will be evaluated (scored 0-3: none, mild, moderate, severe): -Influenza symptoms (respiratory and systemic domains Impact on daily activities Impact on emotions Impact on others
Time frame: Baseline to Day 15
Rate of decline in quantitative viral load (subjects not intubated at baseline)
Time frame: Baseline to Day 8
Rate of decline in quantitative viral load (subjects intubated at baseline)
Time frame: Baseline to Day 8
Rate of decline in quantitative viral load
Time frame: Baseline to Day 8
Incidence of adverse events
Time frame: Baseline to Day 116
Incidence of serious adverse events
Time frame: Baseline to Day 116
Area under the curve of viral load
Time frame: Baseline to Day 8
Clinical course for ICU patients
Time frame: Baseline to Day 8
Length of hospital stay
Time frame: The duration of hospital stay, an expected average of 7 days
Survival times
Survival times measured from randomization to time of death
Time frame: Baseline to Day 116
This study is withdrawn, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Crucell Holland BV