Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02549222 · ClinicalTrials.gov registry record
A Open Label, Post Marketing Surveillance Study Following Transfusion of INTERCEPT Platelet Components
A clinical trial, sponsored by Cerus Corporation.
- Completed
- Registry status
- 2,291
- Enrollment target
NCT02549222 is a clinical trial that has completed, run by Cerus Corporation. The registered enrollment target is 2,291 participants.
The verdict
NCT02549222 has completed, sponsored by Cerus Corporation.
- COMPLETED
- Registry status
- 2,291 participants
- Enrollment target
Study Summary
This study is a prospective, non-randomized sequential cohort, open label, multi-center, non-inferiority, Phase IV surveillance study following transfusion of INTERCEPT PCs. The patient population will be hematology-oncology patients, including those undergoing hematopoietic stem cell transplant (HSCT), expected to require one or more PC transfusions. For each participating center, the study will start with a brief pilot run-in period with a group of at least 5 patients exposed only to conventional PCs. The purpose of this pilot run-in is to evaluate study logistics and data collection methods within each study center. Data from the pilot phase will be included in the data analysis for the treatment comparison. After the pilot run-in period, the study will be conducted in two sequential patient cohorts: 1) the Control cohort during which study patients will receive only conventional PCs, and 2) the INTERCEPT cohort during which patients will receive only INTERCEPT PCs. Patient enrollment at each Center will be monitored to target similar numbers of patients into the Control and Test Cohorts within each center. Centers may enroll Control and Test patients in ratios that vary from 2:1 to 1:2 due to institutional requirements to move rapidly to full INTERCEPT implementation, or due to availability issues with either Test or Control components. Within each Center, patient enrollment will be stratified in four categories: (1) chemotherapy only; and by use of conditioning regimens for hematopoietic stem cell transplantation (HSCT) in (2) myeloablative conditioning, (3) non-myeloablative conditioning, and (4) reduced intensity using the Center for International Blood and Marrow Transplant Research (CIBMTR) criteria. Note time from last chemotherapy treatment to first study transfusion should be no more than 30 days. To ensure both Test and Control cohorts have a similar allocation ratio (±10% per category) among the conditioning regimen strata, enrollment caps will be se
Interventions
- OTHER Standard of Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,291 participants |
| Start Date | 2015-12 |
| Est. Completion | 2021-05 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02549222
The ClinicalTrials.gov registry entry for NCT02549222 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 2,291 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cerus Corporation, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Standard of Care is the first listed.
NCT02549222 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02549222 about?
NCT02549222 is a clinical study titled "A Open Label, Post Marketing Surveillance Study Following Transfusion of INTERCEPT Platelet Components". This study is a prospective, non-randomized sequential cohort, open label, multi-center, non-inferiority, Phase IV surveillance study following transfusion of INTERCEPT PCs. The patient population will be hematology-oncology patients, including those undergoing hematopoietic stem cell transplant (HS...
What is the current status of trial NCT02549222?
This trial is currently completed. The enrollment target is 2,291 participants. The study started on 2015-12. Estimated completion is 2021-05.
What interventions are being tested in trial NCT02549222?
The interventions under investigation include: Standard of Care (OTHER).
Who is sponsoring clinical trial NCT02549222?
This trial is sponsored by Cerus Corporation, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.