Efficacy and Safety Study of Platelets Treated for Pathogen Inactivation and Stored for Up to Seven Days

NCT00261924 | Completed Phase 3 DMC

• 1 other identifier: 451-P-A-NIV
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To determine if platelets treated for pathogen inactivation and stored for 6 to 7 days are safe and effective compared to platelets collected by the same method, stored for the same amount of time and not treated for pathogen inactivation.

Conditions

Thrombocytopenia

Keywords

Thrombocytopenic patients

Outcome Measures

Primary Outcomes (1)

• 1 hour corrected count increment for platelets

  1-h CCI

  One hour after platelet transfusion

Secondary Outcomes (1)

• Transfusion related adverse events

  24 hours after transfusion

Study Arms (2)

Intercept Platelets

EXPERIMENTAL

Study patients receiving platelets that have been processed with the INTERCEPT pathogen inactivation system

Device: Transfusion of Pathogen Inactivated Platelets stored for 6-7 days

Conventional Platelets

ACTIVE COMPARATOR

Study patients receiving platelets processed by standard method without the INTERCEPT pathogen inactivation system

Device: Transfusion of Pathogen Inactivated Platelets stored for 6-7 days

Interventions

Transfusion of Pathogen Inactivated Platelets stored for 6-7 days DEVICE

pathogen inactivation of platelets for transfusion

Also known as: INTERCEPT

Conventional Platelets; Intercept Platelets

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 16 years old
• Written informed consent
• Thrombocytopenia, or expected to develop thrombocytopenia requiring platelet transfusion within 15 days of randomization
• Undergoing one haematopoietic stem cell transplantation and/or admitted for treatment of acute or chronic leukaemia, lymphoma, multiple myeloma or myelodysplasia

You may not qualify if:

• Refractoriness to platelet transfusion
• Immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura, or hemolytic uremic syndrome
• Use of IL-11 (Neumega®) or other investigational platelet growth factor
• Disseminated intravascular coagulation (DIC)
• Clinically or radiologically detectable splenomegaly
• Previous participation in the study

Sponsors & Collaborators

• Cerus Corporation: lead

Study Sites (1)

SNBTS National Science Laboratory, Edinburgh and Western General Hospital

Edinburgh, United Kingdom

Location

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Larry Corash, M.D.

  Cerus Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 5, 2005
• First Posted: December 6, 2005
• Study Start: October 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 14, 2010

Record last verified: 2005-12

Locations

GB (1)