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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01992276




Registration number
NCT01992276
Ethics application status
Date submitted
11/11/2013
Date registered
25/11/2013
Date last updated
4/03/2014

Titles & IDs
Public title
Assessment of Efficacy of CR8020 and CR6261, Monoclonal Antibodies, Against Influenza Infection
Scientific title
Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of CR8020 and CR6261 in Hospitalized Patients With Influenza A Infection
Secondary ID [1] 0 0
2013-003341-41
Secondary ID [2] 0 0
CR102576
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - CR8020
Other interventions - CR6261
Other interventions - Placebo

Experimental: CR8020 - Investigational monoclonal antibody against influenza A viruses

Experimental: CR6261 - Investigational monoclonal antibody against influenza A viruses

Placebo Comparator: Placebo - Dextrose: 5% in water


Other interventions: CR8020
30 mg/kg administered as a single 2-hour intravenous infusion on Day 1

Other interventions: CR6261
30 mg/kg administered as a single 2-hour intravenous infusion on Day 1

Other interventions: Placebo
Administered as a single 2-hour intravenous infusion on Day 1
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of decline in quantitative viral load
Timepoint [1] 0 0
Baseline to Day 8
Secondary outcome [1] 0 0
Clinical improvement
Timepoint [1] 0 0
Baseline to Day 15
Secondary outcome [2] 0 0
Rate of decline in quantitative viral load (subjects not intubated at baseline)
Timepoint [2] 0 0
Baseline to Day 8
Secondary outcome [3] 0 0
Rate of decline in quantitative viral load (subjects intubated at baseline)
Timepoint [3] 0 0
Baseline to Day 8
Secondary outcome [4] 0 0
Rate of decline in quantitative viral load
Timepoint [4] 0 0
Baseline to Day 8
Secondary outcome [5] 0 0
Incidence of adverse events
Timepoint [5] 0 0
Baseline to Day 116
Secondary outcome [6] 0 0
Incidence of serious adverse events
Timepoint [6] 0 0
Baseline to Day 116
Secondary outcome [7] 0 0
Area under the curve of viral load
Timepoint [7] 0 0
Baseline to Day 8
Secondary outcome [8] 0 0
Clinical course for ICU patients
Timepoint [8] 0 0
Baseline to Day 8
Secondary outcome [9] 0 0
Length of hospital stay
Timepoint [9] 0 0
The duration of hospital stay, an expected average of 7 days
Secondary outcome [10] 0 0
Survival times
Timepoint [10] 0 0
Baseline to Day 116

Eligibility
Key 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/
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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/

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2015
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Melbourne
Recruitment hospital [3] 0 0
- Parkville - Vic
Recruitment hospital [4] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Parkville - Vic
Recruitment postcode(s) [4] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
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Minnesota
Country [8] 0 0
United States of America
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Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
Country [16] 0 0
Belgium
State/province [16] 0 0
Brussel
Country [17] 0 0
Belgium
State/province [17] 0 0
Edegem
Country [18] 0 0
Belgium
State/province [18] 0 0
Gent
Country [19] 0 0
Belgium
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Leuven
Country [20] 0 0
Brazil
State/province [20] 0 0
Belo Horizonte
Country [21] 0 0
Brazil
State/province [21] 0 0
Campinas
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Brazil
State/province [22] 0 0
Curitiba
Country [23] 0 0
Brazil
State/province [23] 0 0
Passo Fundo
Country [24] 0 0
Brazil
State/province [24] 0 0
Porto Alegre
Country [25] 0 0
Brazil
State/province [25] 0 0
Ribeirão Preto
Country [26] 0 0
Brazil
State/province [26] 0 0
Sao Jose Do Rio Preto
Country [27] 0 0
Brazil
State/province [27] 0 0
Sao Paulo
Country [28] 0 0
Brazil
State/province [28] 0 0
São Paulo
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Sofia
Country [30] 0 0
Canada
State/province [30] 0 0
Ontario
Country [31] 0 0
Canada
State/province [31] 0 0
Toronto N/A
Country [32] 0 0
Canada
State/province [32] 0 0
Toronto
Country [33] 0 0
France
State/province [33] 0 0
Clermont-Ferrand
Country [34] 0 0
France
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Limoges
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France
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Lyon
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France
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Paris
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France
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Rennes
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France
State/province [38] 0 0
St Priest-En-Jarez
Country [39] 0 0
Germany
State/province [39] 0 0
Donaustauf
Country [40] 0 0
Germany
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Jena
Country [41] 0 0
Germany
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Leipzig
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Germany
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Potsdam
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Netherlands
State/province [43] 0 0
Amsterdam
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Netherlands
State/province [44] 0 0
Apeldoorn
Country [45] 0 0
Netherlands
State/province [45] 0 0
Leiden
Country [46] 0 0
Netherlands
State/province [46] 0 0
Utrecht
Country [47] 0 0
South Africa
State/province [47] 0 0
Benoni
Country [48] 0 0
South Africa
State/province [48] 0 0
Durban
Country [49] 0 0
South Africa
State/province [49] 0 0
Pretoria Gauteng
Country [50] 0 0
Spain
State/province [50] 0 0
Alicante
Country [51] 0 0
Spain
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Barcelona
Country [52] 0 0
Spain
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Córdoba
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Spain
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Elche
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Spain
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Madrid
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Spain
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San Sebastian
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Spain
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Santander N/A
Country [57] 0 0
Spain
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Tarragona
Country [58] 0 0
Sweden
State/province [58] 0 0
Malmö
Country [59] 0 0
Sweden
State/province [59] 0 0
Stockholm
Country [60] 0 0
Sweden
State/province [60] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Crucell Holland BV
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Division of Microbiology and Infectious Diseases (DMID)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Institutes of Health (NIH)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01992276
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Crucell Holland BV Clinical Trial
Address 0 0
Crucell Holland BV
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01992276