AzTrials
AzTrials

InfluenzaPhase 2NCT01992276

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

A Phase 2 study testing CR8020 and CR6261 in people with Influenza, run by Crucell Holland BV at 68 sites in 12 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Influenza
What is being tested?
CR8020 and CR6261
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
68 sitesin 12 countries
Study dates
Dec 2013to Feb 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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/

Who cannot join

  • 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/

Trial locations and contacts

68 sites in 12 countries.

68 sites in 12 countries

United States21 sites

  • Study site

    Baltimore, Maryland

  • Study site

    Chicago, Illinois

  • Study site

    Dayton, Ohio

  • Study site

    Detroit, Michigan

  • Study site

    Fresno, California

  • Study site

    Hackensack, New Jersey

  • Study site

    Houston, Texas

  • Study site

    Maywood, Illinois

  • Study site

    Minneapolis, Minnesota

  • Study site

    Nashville, Tennessee

  • Study site

    New York, New York

  • Study site

    Rochester, New York

  • Study site

    Royal Oak, Michigan

  • Study site

    Somers Point, New Jersey

  • Study site

    St Louis, Missouri

  • Study site

    Stanford, California

  • Study site

    Tampa, Florida

  • Study site

    Troy, Michigan

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Wilkes-Barre, Pennsylvania

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

Brazil8 sites

  • Study site

    Belo Horizonte

  • Study site

    Campinas

  • Study site

    Curitiba

  • Study site

    Passo Fundo

  • Study site

    Porto Alegre

  • Study site

    Ribeirão Preto

  • Study site

    São José do Rio Preto

  • Study site

    São Paulo

Other trials in Brazil

Spain8 sites

  • Study site

    Alicante

  • Study site

    Barcelona

  • Study site

    Córdoba

  • Study site

    Donostia / San Sebastian

  • Study site

    Elche

  • Study site

    Madrid

  • Study site

    Santander

  • Study site

    Tarragona

Other trials in Spain

France6 sites

  • Study site

    Clermont-Ferrand

  • Study site

    Limoges

  • Study site

    Lyon

  • Study site

    Paris

  • Study site

    Rennes

  • Study site

    Saint-Priest-en-Jarez

Other trials in France

Australia4 sites

  • Study site

    Adelaide

  • Study site

    Melbourne

  • Study site

    Parkville - Vic

  • Study site

    Westmead

Other trials in Australia

Belgium4 sites

  • Study site

    Brussels

  • Study site

    Edegem

  • Study site

    Ghent

  • Study site

    Leuven

Other trials in Belgium

Germany4 sites

  • Study site

    Donaustauf

  • Study site

    Jena

  • Study site

    Leipzig

  • Study site

    Potsdam

Other trials in Germany

Netherlands4 sites

  • Study site

    Amsterdam

  • Study site

    Apeldoorn

  • Study site

    Leiden

  • Study site

    Utrecht

Other trials in Netherlands

South Africa3 sites

  • Study site

    Benoni

  • Study site

    Durban

  • Study site

    Pretoria Gauteng

Other trials in South Africa

Sweden3 sites

  • Study site

    Malmö

  • Study site

    Stockholm

  • Study site

    Uppsala

Other trials in Sweden

Canada2 sites

  • Study site

    Toronto, Ontario

  • Study site

    Toronto

Other trials in Canada

Bulgaria1 site

  • Study site

    Sofia

Other trials in Bulgaria

About this study

Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of CR8020 and CR6261 in Hospitalized Patients With Influenza A Infection

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

Read the 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
Being tested
CR8020, CR6261, Placebo
Keywords
Influenza, Virus, Monoclonal Antibody, Immunization, Treatment
Medical subject headings
Influenza, Human, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CR8020Biological

    Also called CR8020 30 mg/kg by iv infusion

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

  • CR6261Biological

    Also called CR6261 30 mg/kg by iv infusion

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

  • PlaceboBiological

    Also called Placebo by iv infusion

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

Study groups in NCT01992276
Study groupRoleWhat they receive
CR8020ExperimentalInvestigational monoclonal antibody against influenza A viruses
Receives: Biological: CR8020
CR6261ExperimentalInvestigational monoclonal antibody against influenza A viruses
Receives: Biological: CR6261
PlaceboPlacebo comparatorDextrose: 5% in water
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of decline in quantitative viral load

    Measured: Baseline to Day 8

Secondary outcomes (10)

  1. 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

    Measured: Baseline to Day 15

  2. Rate of decline in quantitative viral load (subjects not intubated at baseline)

    Measured: Baseline to Day 8

  3. Rate of decline in quantitative viral load (subjects intubated at baseline)

    Measured: Baseline to Day 8

  4. Rate of decline in quantitative viral load

    Measured: Baseline to Day 8

  5. Incidence of adverse events

    Measured: Baseline to Day 116

  6. Incidence of serious adverse events

    Measured: Baseline to Day 116

  7. Area under the curve of viral load

    Measured: Baseline to Day 8

  8. Clinical course for ICU patients

    Measured: Baseline to Day 8

  9. Length of hospital stay

    Measured: The duration of hospital stay, an expected average of 7 days

  10. Survival times

    Survival times measured from randomization to time of death

    Measured: Baseline to Day 116

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionOct 2014 (estimated)
  4. Study completionFeb 2015 (estimated)

Why it stopped: Due to preliminary efficacy results from an influenza challenge trial

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01992276
Sponsor's protocol ID
CR102576
Other IDs
2013-003341-41, CR6261CR8020FLZ2001
Status last verified
Mar 2014
First submitted
11 Nov 2013
Last updated
4 Mar 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CR8020 and CR6261 in people with Influenza, run by Crucell Holland BV at 68 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Brazil, Spain, France, Australia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of decline in quantitative viral load (time frame: Baseline to Day 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01992276.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in