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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

Primary Purpose

Systemic Lupus Erythematosus (SLE)

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

LupusorbTM

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus (SLE)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants, either male or female are at least 18 years of age at entry.
Have diagnosed documented SLE, determined at least by 4 criteria as defined by the American Rheumatism Association ARA
Active SLE disease with a SLEDAI score greater than 3
Serum anti-VRT101 at least 0.4 O.D.
Be willing and able to comply with the protocol for the duration of the study.
Participant understands the nature of the procedure and provides written informed consent prior to any study procedure.
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:

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
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.
Patient suffers an active or chronic infection.
If female, reports pregnancy, breast-feeding (or inadequate birth control)
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)
Participation in another clinical trial within 2 months prior to start of this study.
Subject unwilling or unable to comply with the requirements of the protocol.
Any condition that the investigator feels would interfere with trial participation and evaluation of the results.
Subject unwilling and unable to provide inform consent.
Subjects receiving ACE inhibitors treatment 7 days prior to plasmapheresis procedure.

Sites / Locations

Hadassah Ein- Kerem

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Single arm open label

Outcomes

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.

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.

Full Information

NCT ID

NCT00608127

First Posted

January 23, 2008

Last Updated

May 21, 2008

Sponsor

Verto LTD

1. Study Identification

Unique Protocol Identification Number

NCT00608127

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Unknown status

Study Start Date

January 2007 (undefined)

Primary Completion Date

May 2008 (Anticipated)

Study Completion Date

August 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Verto LTD

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus (SLE)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Single arm open label

Intervention Type

Device

Intervention Name(s)

LupusorbTM

Intervention Description

Single treatment

Primary Outcome Measure Information:

Title

Time Frame

Within 2 months

Secondary Outcome Measure Information:

Title

Time Frame

within 2 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants, either male or female are at least 18 years of age at entry. Have diagnosed documented SLE, determined at least by 4 criteria as defined by the American Rheumatism Association ARA Active SLE disease with a SLEDAI score greater than 3 Serum anti-VRT101 at least 0.4 O.D. Be willing and able to comply with the protocol for the duration of the study. Participant understands the nature of the procedure and provides written informed consent prior to any study procedure. 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: Patient has Severe proliferative lupus nephritis: Rapidly progressive glomerulonephritis (doubling of serum creatinine during last 3 months); or Severe impairment of renal function Cr more than 2.5 mg/dL Patient Begin immunosuppressive therapy recently: Beginning treatment with azathioprine, mycophenolic acid, cyclosporine or methotrexate within 4 weeks. Cyclophosphamide-an IV pulse within the last 3 months Pulse therapy with glucocorticoids during the 4 weeks before study entry. Patient is in on another experimental therapy. Patient suffers an active or chronic infection. If female, reports pregnancy, breast-feeding (or inadequate birth control) Confounding medical illness that in the judgment of investigators would pose. Added risk for study participants such as: Unstable coronary artery disease, cardiomyopathy or dysrhythmia requiring therapy Hematologic disease (Hb < 7 G/dL, platelets < 50,000/dL or WBC < 2,000/dL). Bleeding tendency Hypogammaglobulinemia (Serum IgG< 500mg/dL) Participation in another clinical trial within 2 months prior to start of this study. Subject unwilling or unable to comply with the requirements of the protocol. Any condition that the investigator feels would interfere with trial participation and evaluation of the results. Subject unwilling and unable to provide inform consent. Subjects receiving ACE inhibitors treatment 7 days prior to plasmapheresis procedure.

Facility Information:

Facility Name

Hadassah Ein- Kerem

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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