NCT02295501

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

A Prospective, Open Label Observational, 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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Cerus Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Acute Ebola Virus Disease

Interventions

Type	Name	Description
BIOLOGICAL	INTERCEPT Plasma	Plasma will be collected from eligible volunteer donors who have recovered from acute EVD (see EBOV convalescent donor inclusion criteria). This donor plasma will be collected by apheresis donation (approximately 650-1300 mL per donation at physician discretion) and treated with the IBS for plasma.

Timeline

• Start date: 2014-12-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2014-11-20
• Last updated: 2021-03-29

Locations

2 sites across 1 country: United States