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

NCT02295501 | Terminated Phase 1

• 1 other identifier: CLI 00113
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Ebola Virus Disease

Keywords

Pathogen inactivation; ebola; convalescent plasma; EBOV; amotosalen; Provide access to the potential therapeutic benefit of EBOV convalescent plasma containing antibodies to EBOV.

Outcome Measures

Primary Outcomes (3)

• Proportion of subjects who survive EVD

  through hospital discharge up to 1 year

• Proportion of subjects with adverse events

  Up to 24 hours post transfusion

• Proportion of subjects with Serious Adverse Events

  Up to 7 days post-transfusion

Secondary Outcomes (5)

• Time from diagnosis of acute EVD to death due to acute EVD

  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.

  through hospital discharge up to 1 year

• Time from diagnosis of acute EVD to clinical remission.

  through hospital discharge up to 1 year

• Reduction of EBOV viral load titers by nucleic acid testing prior to hospital discharge.

  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

  pre and post transfusion up to 1 year

Study Arms (1)

EBOV convalescent donors

EXPERIMENTAL

EBOV convalescent donors for passive immune therapy in subjects with acute EVD

Biological: INTERCEPT Plasma

Interventions

INTERCEPT Plasma BIOLOGICAL

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.

Also known as: INTERCEPT Blood System for Plasma

EBOV convalescent donors

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Recovered from Ebola Virus Disease (EVD) by clinical criteria and declared clinically asymptomatic of active EVD.
• Twenty-eight (28) days from hospital discharge.
• Two negative test results for EBOV nucleic acid by a sensitive nucleic acid test method with blood samples drawn at least 48 hours apart.
• ABO blood group and RhD typing performed and donor anti-A and anti-B titers performed.
• Measurement of antibodies to EBOV, when feasible and ultimately measurement of neutralizing antibodies to EBOV, when available.
• Conformity to age and weight standards for blood donors for plasma donation. Variance from standards may be acceptable with evaluation by treating physician(s) and with donor or legal guardian consent for non-conforming donors when collection of reduced volumes of plasma may be of therapeutic value.
• Cleared by treating physician for apheresis plasma donation.
• Written signed informed consent to donate 650-1300 mL plasma by apheresis at frequencies of twice per week, at the discretion of the treating physician.
• Acute EVD diagnosed by nucleic acid testing and meeting established case definitions (World Health Organization 2014).
• Subject or legal guardian provides written informed consent to receive INTERCEPT plasma.

You may not qualify if:

• Active EVD
• Documented food allergy to psoralens

Sponsors & Collaborators

• Cerus Corporation: lead

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (1)

• Dean CL, Hooper JW, Dye JM, Zak SE, Koepsell SA, Corash L, Benjamin RJ, Kwilas S, Bonds S, Winkler AM, Kraft CS. Characterization of Ebola convalescent plasma donor immune response and psoralen treated plasma in the United States. Transfusion. 2020 May;60(5):1024-1031. doi: 10.1111/trf.15739. Epub 2020 Mar 4.

  PMID: 32129478 RESULT

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 20, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 29, 2021

Record last verified: 2021-03

Locations

US (2)