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

NCT ID: NCT01992276

Last Updated: 2014-03-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-02-28

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CR8020

Investigational monoclonal antibody against influenza A viruses

Group Type: EXPERIMENTAL

CR8020

Intervention Type: BIOLOGICAL

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

CR6261

Investigational monoclonal antibody against influenza A viruses

Group Type: EXPERIMENTAL

CR6261

Intervention Type: BIOLOGICAL

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

Placebo

Dextrose: 5% in water

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Administered as a single 2-hour intravenous infusion on Day 1

Interventions

CR8020

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

Intervention Type: BIOLOGICAL

CR6261

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

Intervention Type: BIOLOGICAL

Placebo

Administered as a single 2-hour intravenous infusion on Day 1

Intervention Type: BIOLOGICAL

Other Intervention Names

CR8020 30 mg/kg by iv infusion; CR6261 30 mg/kg by iv infusion; Placebo by iv infusion

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/

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Division of Microbiology and Infectious Diseases (DMID)

UNKNOWN

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Crucell Holland BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Crucell Holland BV Clinical Trial

Role: STUDY_DIRECTOR

Crucell Holland BV

Locations

Fresno, California, United States

Stanford, California, United States

Washington D.C., District of Columbia, United States

Tampa, Florida, United States

Chicago, Illinois, United States

Maywood, Illinois, United States

Baltimore, Maryland, United States

Detroit, Michigan, United States

Royal Oak, Michigan, United States

Troy, Michigan, United States

Minneapolis, Minnesota, United States

St Louis, Missouri, United States

Hackensack, New Jersey, United States

Somers Point, New Jersey, United States

New York, New York, United States

Rochester, New York, United States

Winston-Salem, North Carolina, United States

Dayton, Ohio, United States

Wilkes-Barre, Pennsylvania, United States

Nashville, Tennessee, United States

Houston, Texas, United States

Adelaide, , Australia

Melbourne, , Australia

Parkville - Vic, , Australia

Westmead, , Australia

Brussels, , Belgium

Edegem, , Belgium

Ghent, , Belgium

Leuven, , Belgium

Belo Horizonte, , Brazil

Campinas, , Brazil

Curitiba, , Brazil

Passo Fundo, , Brazil

Porto Alegre, , Brazil

Ribeirão Preto, , Brazil

São José do Rio Preto, , Brazil

São Paulo, , Brazil

Sofia, , Bulgaria

Toronto, Ontario, Canada

Toronto, , Canada

Clermont-Ferrand, , France

Limoges, , France

Lyon, , France

Paris, , France

Rennes, , France

Saint-Priest-en-Jarez, , France

Donaustauf, , Germany

Jena, , Germany

Leipzig, , Germany

Potsdam, , Germany

Amsterdam, , Netherlands

Apeldoorn, , Netherlands

Leiden, , Netherlands

Utrecht, , Netherlands

Benoni, , South Africa

Durban, , South Africa

Pretoria Gauteng, , South Africa

Alicante, , Spain

Barcelona, , Spain

Córdoba, , Spain

Donostia / San Sebastian, , Spain

Elche, , Spain

Madrid, , Spain

Santander, , Spain

Tarragona, , Spain

Malmo, , Sweden

Stockholm, , Sweden

Uppsala, , Sweden

Countries

United States; Australia; Belgium; Brazil; Bulgaria; Canada; France; Germany; Netherlands; South Africa; Spain; Sweden

Other Identifiers

2013-003341-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR6261CR8020FLZ2001

Identifier Type: OTHER

Identifier Source: secondary_id

CR102576

Identifier Type: -

Identifier Source: org_study_id