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

Dengue Virus Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305732
• Other study ID #: CLI 00108
• Status: Completed
• Start date: March 2015
• Est. completion date: May 2016

Study information

• Verified date: December 2017
• Source: Cerus Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Upon written informed consent, patients will be transfused with study PCs according to local practices. Each patient will be supported with platelets as clinically indicated in a manner that is consistent with the local standard of care. The study will be conducted in two phases. During the pilot phase, patients will sign informed consent to have study data collected following transfusion with conventional PCs. The objective of the pilot phase is to evaluate study logistics and data collection methods. During the INTERCEPT Treatment Use phase, patients will sign informed consent to receive INTERCEPT PCs, provide blood samples, and collect study data (demographics, transfusion data, and safety data).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria

• 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).

Related Conditions & MeSH terms

• Chikungunya Fever
• Chikungunya Virus
• Dengue
• Dengue Virus

Intervention

Biological:
• INTERCEPT Platelets
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.

Locations

Country	Name	City	State
Puerto Rico	Hospital General Menonita de Aibonito	Aibonito
Puerto Rico	Hospital General Menonita de Caguas	Caguas
Puerto Rico	Hospital General Menonita de Cayey	Cayey
Puerto Rico	Center Hospital Manati	Manati
Puerto Rico	Hospital San Lucas Ponce	Ponce
Puerto Rico	Hospital La Concepcion San German	San German
Puerto Rico	Centro Cardiovascular de Puerto Rico and the Caribbean	San Juan
Puerto Rico	Veteran Administration	San Juan

Sponsors (2)

Lead Sponsor	Collaborator
Cerus Corporation	American National Red Cross

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The Proportion of Patients With a Confirmed Case of Transfusion-transmitted Chikungunya Virus or Dengue Infection		1 year
Primary	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
Primary	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
Primary	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