Clinical Trial: A Prospective, Open Label, Phase 1 Safety Study of Passive Immune Therapy During Acute Ebola Virus Disease Using Transfusion of INTERCEPT Plasma Prepared From Volunteer Donors Who Have Recovered From Ebola Virus Disease

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: A Prospective, Open Label Observational, Phase 1 Safety Study of Passive Immune Therapy During Acute Ebola Virus Disease Using Transfusion of INTERCEPT Plasma Prepared Fro

Brief Summary: The objective of this Phase 1 safety study is to provide access to the potential therapeutic benefit of EBOV convalescent plasma containing antibodies to EBOV. The risk of exposure to plasma from donors who may be infected with other transfusion-transmitted pathogens, not detectable by current licensed donor testing procedures, will be mitigated by using pathogen inactivation to minimize the risk of the TTI from these donors, who would otherwise be deferred and ineligible for blood donation.

Detailed Summary:

The objective of this Phase 1 safety study is to provide access to the potential therapeutic benefit of EBOV convalescent plasma containing antibodies to EBOV. The risk of exposure to plasma from donors who may be infected with other transfusion-transmitted pathogens, not detectable by current licensed donor testing procedures, will be mitigated by using pathogen inactivation to minimize the risk of the TTI from these donors, who would otherwise be deferred and ineligible for blood donation.

The study is designed as a prospective, open label, multi-center, single arm study to evaluate the safety and efficacy of INTERCEPT plasma prepared from EBOV convalescent donors for passive immune therapy in subjects with acute EVD.

Data will be collected to assess the safety of this intervention by monitoring adverse events in the immediate 24-hour post transfusion period. Efficacy will be assessed by monitoring the clinical status of treated subjects with respect to clearance of EBOV by using nucleic acid assays to measure pre and post treatment viral titers. A number of clinical parameters indicative of end-organ damage during acute EVD will be monitored to determine if passive immune therapy affects the onset and duration of renal failure and acute lung injury. In addition, blood samples will be collected pre and post transfusion of convalescent EBOV INTERCEPT plasma to determine if biomarkers of endothelial injury are impacted, and if they can be used to guide plasma transfusion therapy to establish a dosing regimen and duration of treatment.


Sponsor: Cerus Corporation

Current Primary Outcome:

  • Proportion of subjects who survive EVD [ Time Frame: through hospital discharge up to 1 year ]
  • Proportion of subjects with adverse events [ Time Frame: Up to 24 hours post transfusion ]
  • Proportion of subjects with Serious Adverse Events [ Time Frame: Up to 7 days post-transfusion ]


Original Primary Outcome:

  • Proportion of subjects who survive EBV [ Time Frame: through hospital discharge up to 1 year ]
  • Proportion of subjects with adverse events [ Time Frame: Up to 8 hours post transfusion ]
  • Proportion of subjects with Serious Adverse Events [ Time Frame: Up to 7 days post-transfusion ]


Current Secondary Outcome:

  • Time from diagnosis of acute EVD to death due to acute EVD [ Time Frame: censored at hospital discharge up to 1 year ]
  • Proportion of subjects with clinical remission, where clinical remission is defined as absence of clinical symptoms indicative of EVD and at least two negative EBOV nucleic acid tests at least 48 hours apart prior to hospital discharge. [ Time Frame: through hospital discharge up to 1 year ]
  • Time from diagnosis of acute EVD to clinical remission. [ Time Frame: through hospital discharge up to 1 year ]
  • Reduction of EBOV viral load titers by nucleic acid testing prior to hospital discharge. [ Time Frame: through hospital discharge up to 1 year ]
  • Subject hemostatic function pre INTERCEPT plasma and post last INTERCEPT plasma transfusion (prior to discharge), as available: o Prothrombin time o International Normalized Ratio (INR) o Activated partial thromboplastin time o Fibrinogen activity [ Time Frame: pre and post transfusion up to 1 year ]


Original Secondary Outcome:

  • Interval from diagnosis of acute EVD to death [ Time Frame: censored at hospital discharge up to 1 year ]
  • Proportion of subjects with clinical remission as assessed by three consecutive negative tests prior to discharge [ Time Frame: through hospital discharge up to 1 year ]
  • Interval from diagnosis of acute EVD to clinical remission [ Time Frame: through hospital discharge up to 1 year ]
  • Decrease in EBOV viral load titers [ Time Frame: through hospital discharge up to 1 year ]
  • Hemostatic function as assessed by PT, APTT, fibrinogen and D-dimer [ Time Frame: pre and post transfusion up to 1 year ]


Information By: Cerus Corporation

Dates:
Date Received: November 4, 2014
Date Started: December 2014
Date Completion: January 2018
Last Updated: May 4, 2017
Last Verified: May 2017