Safety Study of ECO Conversion System For Red Blood Cells.

This study has been completed.
Sponsor:
Information provided by:
ZymeQuest
ClinicalTrials.gov Identifier:
NCT00261274
First received: November 30, 2005
Last updated: May 22, 2009
Last verified: May 2009

November 30, 2005
May 22, 2009
November 2005
Not Provided
Adverse events, clinically significant bruising over a period of 10 weeks.
Same as current
Complete list of historical versions of study NCT00261274 on ClinicalTrials.gov Archive Site
Unexpected lab test results over 10 weeks.
Same as current
Not Provided
Not Provided
 
Safety Study of ECO Conversion System For Red Blood Cells.
Evaluation of the Safety of Repeated Autologous Infusions of Enzyme-Converted A-to-O (A-ECO) Red Cells Into Group A Volunteers.

The purpose of this study is to demonstrate that small amounts of a person's own red cells, when treated with an enzyme to make A-ECO Red Blood Cells, can be safely re-infused, repeatedly. Each participant will have some blood drawn, treated with an enzyme, washed and re-infused five times. Additional samples of blood will be drawn for testing and evaluation.

This study will involve a statistically valid number of subjects so that firm conclusions may be drawn about the safety of small volumes of A-ECO cells. All participants will receive their own (autologous) red cells that have been either: 1) treated with an enzyme to create A-ECO cells (test group); or 2) washed with saline (control group). The test and control groups will be compared for the rate and extent any adverse reactions or unexpected laboratory test results.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Anemia
Procedure: Enzyme converted ECO red blood cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
Not Provided

Inclusion Criteria:

  • Healthy volunteer subjects who have no clinically apparent cardiovascular, renal, pulmonary, endocrinological, autoimmune or neurological disorders
  • Blood Group A
  • Available for follow up periodically at varying intervals for twelve weeks
  • Have a clinical presumption of a stable blood volume
  • Between 18 and 65 years of age
  • Able to provide informed consent
  • Practicing contraception, other than oral or systemically delivered contraceptives, while participating in the study (subjects of potential reproductive age).

Exclusion Criteria:

  • Women that are pregnant
  • Persons with documented immune deficiencies
  • Persons found to have abnormal platelet function or anti-platelet antibodies as determined by a pre-study screen
  • Persons with a history of idiopathic thrombocytopenic purpura
  • Persons who are bleeding or undergoing an active hemolytic process
  • Persons who have any history of hemorrhagic tendency
  • Persons who are taking any drug known to interfere with hemostasis, or who take combinations of drugs that have been reported to cause hemostatic problems or interfere with laboratory coagulation and platelet function testing
  • Persons who test positive for von Willebrand's disease
  • Persons taking investigational drugs or using an investigational device
  • Persons with a family history of a bleeding disorder
  • Persons with a history of vasculitis
  • Persons with a history of a dermatological disorder that might be confused with bruising in the judgement of the investigator
  • Persons with medical conditions which represent a contraindication to any study procedure, in the judgement of the investigator
  • Persons with unexplained bruising
  • Persons with abnormal laboratory screening tests
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00261274
152-1001
Yes
Doug Clibourn, ZymeQuest, Inc.
ZymeQuest
Not Provided
Study Director: Kurt Gunter, MD ZymeQuest, Inc.
ZymeQuest
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP