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Study to Evaluate Efficacy and Safety of S303 Treated Red Blood Cells (RBCs)in Subjects With Thalassemia Major Requiring Chronic RBC Transfusion

NCT01740531 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2018-07-18

No results posted yet for this study

Summary

To evaluate the efficacy and safety of S 303 treated red blood cells (RBCs) in subjects who require chronic transfusion support due to thalassemia major.

Conditions

  • Thalassemia Major

Interventions

BIOLOGICAL

S-303 Treated Red Blood Cells (RBCs)

BIOLOGICAL

Conventional, untreated Red Blood Cells

Sponsors & Collaborators

  • Cerus Corporation

    lead INDUSTRY

Principal Investigators

  • Raffaella Origa, MD · Ospedale Regionale per le Microcitemie azienda

  • Antonio Piga, MD · University of Torino

  • Yesim Aydinok, MD · Ege University, Izmir, Turkey

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2017-12-21
Completion
2017-12-31

Countries

  • Italy
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01740531 on ClinicalTrials.gov