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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01992276
• Other study ID #: CR102576
• Secondary ID: 2013-003341-41CR
• Status: Withdrawn
• Phase: Phase 2
• First received: November 11, 2013
• Last updated: March 3, 2014
• Start date: December 2013
• Est. completion date: February 2015

Study information

• Verified date: March 2014
• Source: Crucell Holland BV
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: National Health and Medical Research CouncilBrazil: Ministry of HealthGermany: Ministry of HealthSouth Africa: Department of HealthBulgaria: Ministry of HealthCanada: Canadian Institutes of Health ResearchSpain: Ministry of HealthFrance: Ministry of HealthSweden: Medical Products AgencyBelgium: Federal Agency for Medicines and Health Products, FAMHPNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Canada: Health Canada
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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/

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• CR8020
30 mg/kg administered as a single 2-hour intravenous infusion on Day 1
• CR6261
30 mg/kg administered as a single 2-hour intravenous infusion on Day 1
• Placebo
Administered as a single 2-hour intravenous infusion on Day 1

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Crucell Holland BV	Division of Microbiology and Infectious Diseases (DMID), National Institutes of Health (NIH)

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of decline in quantitative viral load		Baseline to Day 8	No
Secondary	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	Baseline to Day 15	No
Secondary	Rate of decline in quantitative viral load (subjects not intubated at baseline)		Baseline to Day 8	No
Secondary	Rate of decline in quantitative viral load (subjects intubated at baseline)		Baseline to Day 8	No
Secondary	Rate of decline in quantitative viral load		Baseline to Day 8	No
Secondary	Incidence of adverse events		Baseline to Day 116	Yes
Secondary	Incidence of serious adverse events		Baseline to Day 116	Yes
Secondary	Area under the curve of viral load		Baseline to Day 8	No
Secondary	Clinical course for ICU patients		Baseline to Day 8	No
Secondary	Length of hospital stay		The duration of hospital stay, an expected average of 7 days	No
Secondary	Survival times	Survival times measured from randomization to time of death	Baseline to Day 116	No