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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Verto LTD.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Verto LTD
ClinicalTrials.gov Identifier:
NCT00608127
First received: January 23, 2008
Last updated: May 21, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention
Systemic Lupus Erythematosus (SLE)
Device: LupusorbTM

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Verto LTD:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
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)
Arms Assigned Interventions
Experimental: 1
Single arm open label
Device: LupusorbTM
Single treatment

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants, either male or female are at least 18 years of age at entry.
  2. Have diagnosed documented SLE, determined at least by 4 criteria as defined by the American Rheumatism Association ARA
  3. Active SLE disease with a SLEDAI score greater than 3
  4. Serum anti-VRT101 at least 0.4 O.D.
  5. Be willing and able to comply with the protocol for the duration of the study.
  6. Participant understands the nature of the procedure and provides written informed consent prior to any study procedure.
  7. If female, must be neither pregnant nor breast-feeding and must lack childbearing potential for the duration of the study.

Exclusion Criteria:

Subjects will be excluded from the study if ANY of the following conditions are present:

  1. Patient has Severe proliferative lupus nephritis:

    1. Rapidly progressive glomerulonephritis (doubling of serum creatinine during last 3 months); or
    2. Severe impairment of renal function Cr more than 2.5 mg/dL
  2. Patient Begin immunosuppressive therapy recently:

    1. Beginning treatment with azathioprine, mycophenolic acid, cyclosporine or methotrexate within 4 weeks.
    2. Cyclophosphamide-an IV pulse within the last 3 months
    3. Pulse therapy with glucocorticoids during the 4 weeks before study entry.
    4. Patient is in on another experimental therapy.
  3. Patient suffers an active or chronic infection.
  4. If female, reports pregnancy, breast-feeding (or inadequate birth control)
  5. Confounding medical illness that in the judgment of investigators would pose.

    Added risk for study participants such as:

    1. Unstable coronary artery disease, cardiomyopathy or dysrhythmia requiring therapy
    2. Hematologic disease (Hb < 7 G/dL, platelets < 50,000/dL or WBC < 2,000/dL).
    3. Bleeding tendency
    4. Hypogammaglobulinemia (Serum IgG< 500mg/dL)
  6. Participation in another clinical trial within 2 months prior to start of this study.
  7. Subject unwilling or unable to comply with the requirements of the protocol.
  8. Any condition that the investigator feels would interfere with trial participation and evaluation of the results.
  9. Subject unwilling and unable to provide inform consent.
  10. Subjects receiving ACE inhibitors treatment 7 days prior to plasmapheresis procedure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608127

Locations
Israel
Hadassah Ein- Kerem
Jerusalem, Israel, 91120
Sponsors and Collaborators
Verto LTD
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Anat Scheiman, Hadassah Medical Center Hospital
ClinicalTrials.gov Identifier: NCT00608127     History of Changes
Other Study ID Numbers: LUP-001-ISR
Study First Received: January 23, 2008
Last Updated: May 21, 2008
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 01, 2014