Study to Evaluate the Safety, Tolerability and Short Term Efficacy of Extracorporeal Specific Immunoadsorption LupusorbTM Columns for the Treatment of Systemic Lupus Erythematosus (SLE) Patients
Systemic Lupus Erythematosus (SLE) is a chronic, autoimmune, inflammatory disease primarily affecting women of childbearing age, and associated with severe morbidity and mortality of its victims. The existing therapy, however, is not specific and its inevitable side effects may themselves be fatal. Therefore, it is a widely recognized need for, and it would be highly advantageous to have a safe, specific rapidly effective and well-defined treatment of SLE, devoid of the disadvantages.
We have shown that VRT101 a peptide present in the extracellular laminin is a target for pathogenic lupus autoantibodies. Using this peptide we have developed the LupusorbTM - an immune-adsorption column which specifically binds pathogenic antibodies from monoclonal cultures as well as from patients` plasma. The investigational product named LupusorbTM Column is a sterile medical device for single use and can be classified into category IIb (synthetic ligands, peptides) according to Annex IX of the European Medical Device Directive 42/93/EEC.
The proposed study, a pilot non-randomized open label study, will test the safety, Tolerability and short term efficacy of a single immunoadsorption procedure in SLE patients.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single - Arm Open - Label Study to Evaluate the Safety, Tolerability and Short Term Efficacy of Extracorporeal Specific Immunoadsorption LupusorbTM Columns for the Treatment of Systemic Lupus Erythematosus (SLE) Patients|
- Safety assessment- Patient's physical examination, vital signs (HR, BP, RR, Rhythm status), lab tests- hematology, CBC & blood biochemistry, Serology panel, anti VRT101 levels, liver and kidney function, urinalysis and SLE serological markers. [ Time Frame: Within 2 months ]
- Efficacy assessment- SLE severity, CBC with differential, ESR, CRP, Blood biochemistry: Serum albumin, Serum Igs, Serology panel: ANA, direct Coomb's; C3, C4, anti-DNA and Serum anti-VRT 101 level and SF 36 Health questionnaire. [ Time Frame: within 2 month ]
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||August 2008|
|Estimated Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Single arm open label
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608127
|Hadassah Ein- Kerem|
|Jerusalem, Israel, 91120|