A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components

NCT02305732 | Completed Results

• 1 other identifier: CLI 00108
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 8

Brief Summary

The rationale for a Treatment Use Investigational Device Exemption (IDE) of INTERCEPT PCs is to address current gaps in platelet transfusion safety in selected geographic regions. The objective is to provide access to INTERCEPT PCs for patients who might be at risk of transfusion-transmitted infection (TTI) due to Chikungunya virus (CHIKV) and Dengue virus (DENV) in regions in which a substantial proportion of the population has been infected or is at risk of infection by these pathogens (Petersen 2014); and the risk of asymptomatic infection among qualified blood donors is recognized (Stramer 2012, Adda 2014). The study is designed as a prospective, open label, multi-center, observational study to evaluate the safety and efficacy of INTERCEPT platelet components.

Conditions

Chikungunya Virus; Dengue Virus

Keywords

Chikungunya virus; CHIKV; Dengue virus; DENV; pathogen inactivation; platelets; Puerto Rico

Outcome Measures

Primary Outcomes (5)

• The Proportion of Transfused INTERCEPT Platelet Components With a Post-treatment Platelet Dose ≥ 3.0×10^11 Platelets.

  INTERCEPT platelet components (PCs) manufactured for this study are leukocyte reduced apheresis PCs processed using the INTERCEPT Blood System (IBS) for platelets. The IBS for platelets is a Class III medical device approved by the FDA for the ex-vivo preparation and storage of pathogen reduced apheresis PCs. The system is used to inactivate a broad range of pathogens, including viruses, bacteria, and protozoan parasites as well as contaminating donor leukocytes. Post-manufacturing, INTERCEPT PCs are either transfused or stored according to blood center standard operating procedures, US FDA, and AABB Guidelines. Subjects enrolled in this study are transfused with INTERCEPT PCs as dictated by the treating physician. One platelet component was treated as one platelet transfusion for the purpose of data analysis in this study.

  1 year

• The Proportion of Patients With a Confirmed Case of Transfusion-transmitted Chikungunya Virus or Dengue Infection

  1 year

• The Proportion of Patients With Any Transfusion Reactions

  Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused.

  1 year

• The Proportion of Patients With Any Unrelated Adverse Event

  Unrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused.

  1 year

• The Proportion of Transfused INTERCEPT Platelet Components Associated With Any Transfusion Reactions and/or Unrelated Adverse Event

  Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused. Unrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused. ""1 Transfusion = 1 Intercept Platelet Component".

  1 year

Interventions

INTERCEPT Platelets BIOLOGICAL

INTERCEPT platelet components (PC). Leukocyte reduced apheresis platelet components collected in Platelet Additive Solution (PAS) or 100% plasma without gamma irradiation, bacterial detection, and Cytomegalovirus (CMV) serology testing.

Eligibility Criteria

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

Study Population

Patients requiring a platelet transfusion.

You may qualify if:

• Patients with a serious disease expected to require or requiring a transfusion of platelet component(s)
• Patient population as defined by each Investigator and their institutional review board (IRB).
• Patient provides written informed consent

You may not qualify if:

• Documented allergy to psoralens
• Neonatal patients treated with phototherapy devices that emit wavelengths less than 425 nm due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.
• Pregnant women in their third trimester of pregnancy (due to possibility the neonate may need bilirubin light treatment after birth).

Sponsors & Collaborators

• Cerus Corporation: lead
• American National Red Cross: collaborator

Study Sites (8)

Hospital General Menonita de Aibonito

Aibonito, 00705, Puerto Rico

Location

Hospital General Menonita de Caguas

Caguas, 00725, Puerto Rico

Location

Hospital General Menonita de Cayey

Cayey, Puerto Rico

Location

Center Hospital Manati

Manatí, 00674, Puerto Rico

Location

Hospital San Lucas Ponce

Ponce, 00733, Puerto Rico

Location

Hospital La Concepcion San German

San Germán, 00683, Puerto Rico

Location

Centro Cardiovascular de Puerto Rico and the Caribbean

San Juan, 00683, Puerto Rico

Location

Veteran Administration

San Juan, 00921, Puerto Rico

Location

Results Point of Contact

• Title: Carol Moore, Senior VP Regulatory Affairs & Quality
• Organization: Cerus

cmoore@cerus.com

925-288-6361

Study Officials

• Susan L Stramer, PhD

  American National Red Cross

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: December 3, 2014
• Study Start: March 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 30, 2018
• Results First Posted: October 30, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

PR (8)