STA-ImmunoDef VIII and STA-Immunodef IX Sample Stability and Fresh-Frozen Study Save

Date Added
August 1st, 2017
PRO Number
Pro00065916
Researcher
John Lazarchick
Keywords
Blood Disorders
Summary

Patients with hereditary blood clotting protein deficiencies of Factor VIII (diagnosis of Hemophilia A) and FIX deficiency (diagnosis of Hemophilia B) will be asked to donate a blood sample to test new reagents from Stago to replace the ones currently used in our laboratory to measure the levels of these clotting factors in plasma. In part one of the study sample once drawn and processed will be immediately have levels of either FVIII or Factor IX measured and then the assay repeated hourly for the next 5 hours to assess sample stability (reproducibility). The purpose of this part of the study is validate the sample stability at room temperature known from the literature described in CLSL guideline. In part two of the study, aliquots of the same samples will be frozen at both -20C and -80C. The -20C samples will be thawed at day 7, 15 and 17 and the Factor VIII and Factor IX assays repeated. The -80C samples will be thawed at days 15, 30 and 32 and the assays repeated. The purpose of this part of the study is to validate the sample stability after freezing at -20C and -80C known from the literature and recognized by CLSI.

Institution
MUSC
Recruitment Contact
John Lazarchick
843-792-3424
lazarj@musc.edu

Safety, tolerability, and pharmacokinetics study of single and multiple subcutaneous doses of turoctocog alfa pegol in patients with haemophilia A Save

Date Added
March 14th, 2017
PRO Number
Pro00063209
Researcher
John Lazarchick
Keywords
Blood Disorders, Drug Studies
Summary

This trial is a first-in-human clinical trial with subcutaneous injections of turoctocog alfa pegol (N8-GP). You must be male, age 12 or older with a diagnosis of hemophilia A to participate. The purpose of the trial is to investigate the potential effect of N8-GP
on prevention of bleeds in previously treated patients with severe hemophilia A. This study would require approximately 10 visits to the research clinic over 5 months. Compensation will be provided for time and travel.

Institution
MUSC
Recruitment Contact
Lauren Card
843-792-5935
cardl@musc.edu

A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients with Severe Hemophilia A Save

Date Added
March 26th, 2013
PRO Number
Pro00022822
Researcher
John Lazarchick
Keywords
Blood Disorders
Summary

The purpose of this research trial is to find out how effective a new Factor VIII (FVIII) product called N8-GP is in prevention and treatment of bleeding episodes, and to find out if there are any unwanted effects related to its use.

Institution
MUSC
Recruitment Contact
Lisa Kuisel
843-792-0560
kuisel@musc.edu

Change_preferences

-- OR --

Create_login