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

Primary Purpose

Influenza

Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CR8020
CR6261
Placebo
Sponsored by
Crucell Holland BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza focused on measuring Influenza, Virus, Monoclonal Antibody, Immunization, Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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/

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

CR8020

CR6261

Placebo

Arm Description

Investigational monoclonal antibody against influenza A viruses

Investigational monoclonal antibody against influenza A viruses

Dextrose: 5% in water

Outcomes

Primary Outcome Measures

Rate of decline in quantitative viral load

Secondary Outcome Measures

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
Rate of decline in quantitative viral load (subjects not intubated at baseline)
Rate of decline in quantitative viral load (subjects intubated at baseline)
Rate of decline in quantitative viral load
Incidence of adverse events
Incidence of serious adverse events
Area under the curve of viral load
Clinical course for ICU patients
Length of hospital stay
Survival times
Survival times measured from randomization to time of death

Full Information

First Posted
November 11, 2013
Last Updated
March 3, 2014
Sponsor
Crucell Holland BV
Collaborators
Division of Microbiology and Infectious Diseases (DMID), National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01992276
Brief Title
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

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Due to preliminary efficacy results from an influenza challenge trial
Study Start Date
December 2013 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Crucell Holland BV
Collaborators
Division of Microbiology and Infectious Diseases (DMID), National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Virus, Monoclonal Antibody, Immunization, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CR8020
Arm Type
Experimental
Arm Description
Investigational monoclonal antibody against influenza A viruses
Arm Title
CR6261
Arm Type
Experimental
Arm Description
Investigational monoclonal antibody against influenza A viruses
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dextrose: 5% in water
Intervention Type
Biological
Intervention Name(s)
CR8020
Other Intervention Name(s)
CR8020 30 mg/kg by iv infusion
Intervention Description
30 mg/kg administered as a single 2-hour intravenous infusion on Day 1
Intervention Type
Biological
Intervention Name(s)
CR6261
Other Intervention Name(s)
CR6261 30 mg/kg by iv infusion
Intervention Description
30 mg/kg administered as a single 2-hour intravenous infusion on Day 1
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo by iv infusion
Intervention Description
Administered as a single 2-hour intravenous infusion on Day 1
Primary Outcome Measure Information:
Title
Rate of decline in quantitative viral load
Time Frame
Baseline to Day 8
Secondary Outcome Measure Information:
Title
Clinical improvement
Description
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
Title
Rate of decline in quantitative viral load (subjects not intubated at baseline)
Time Frame
Baseline to Day 8
Title
Rate of decline in quantitative viral load (subjects intubated at baseline)
Time Frame
Baseline to Day 8
Title
Rate of decline in quantitative viral load
Time Frame
Baseline to Day 8
Title
Incidence of adverse events
Time Frame
Baseline to Day 116
Title
Incidence of serious adverse events
Time Frame
Baseline to Day 116
Title
Area under the curve of viral load
Time Frame
Baseline to Day 8
Title
Clinical course for ICU patients
Time Frame
Baseline to Day 8
Title
Length of hospital stay
Time Frame
The duration of hospital stay, an expected average of 7 days
Title
Survival times
Description
Survival times measured from randomization to time of death
Time Frame
Baseline to Day 116

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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/
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Crucell Holland BV Clinical Trial
Organizational Affiliation
Crucell Holland BV
Official's Role
Study Director
Facility Information:
City
Fresno
State/Province
California
Country
United States
City
Stanford
State/Province
California
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Maywood
State/Province
Illinois
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Royal Oak
State/Province
Michigan
Country
United States
City
Troy
State/Province
Michigan
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Hackensack
State/Province
New Jersey
Country
United States
City
Somers Point
State/Province
New Jersey
Country
United States
City
New York
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Dayton
State/Province
Ohio
Country
United States
City
Wilkes Barre
State/Province
Pennsylvania
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Houston
State/Province
Texas
Country
United States
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
State/Province
Ontario
Country
Canada
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

12. IPD Sharing Statement

Learn more about this trial

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

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