Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome
NCT ID: NCT01205087
Last Updated: 2011-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2010-09-30
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Placebo
OKT3
Oral anti-CD3 MAb will be administered at a dosage level of 0.2 or 1.0 or 5.0 mg per day for 30 days. Up of 9 patients will be treated at each dosage level, and up to additional 9 patients will receive placebo.
OKT3 - 0.2
OKT3
Oral anti-CD3 MAb will be administered at a dosage level of 0.2 or 1.0 or 5.0 mg per day for 30 days. Up of 9 patients will be treated at each dosage level, and up to additional 9 patients will receive placebo.
OKT3 - 1
OKT3
Oral anti-CD3 MAb will be administered at a dosage level of 0.2 or 1.0 or 5.0 mg per day for 30 days. Up of 9 patients will be treated at each dosage level, and up to additional 9 patients will receive placebo.
OKT3 - 5
OKT3
Oral anti-CD3 MAb will be administered at a dosage level of 0.2 or 1.0 or 5.0 mg per day for 30 days. Up of 9 patients will be treated at each dosage level, and up to additional 9 patients will receive placebo.
Interventions
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OKT3
Oral anti-CD3 MAb will be administered at a dosage level of 0.2 or 1.0 or 5.0 mg per day for 30 days. Up of 9 patients will be treated at each dosage level, and up to additional 9 patients will receive placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Men and women age 18 to 75 years (inclusive)
3. Patients with biopsy proven NASH within the last 3 years
4. Altered glucose metabolism, including diabetes (non treated, or treated with up to 2 drugs (not including insulin) without any change in medication for at least 2 months prior to enrollment), impaired fasting glucose or impaired glucose tolerance.
5. HBA1C between 5.5 and 14%.
Exclusion Criteria
2. Subjects who have had a prior gastrointestinal surgery.
3. Subjects with a clinically significant infectious, immune mediated or malignant disease
4. Subjects who are receiving an elemental diet or parenteral nutrition.
5. Subjects who have been treated with any type of immune modulatory drug including steroids or NSAID within the last 4 weeks
6. Subjects who have received either methotrexate or cyclosporine or anti TNF-β (infliximab, Remicade), anti-integrin (namixilab) or who have participated in any other clinical trial within the last 3 months.
7. Subjects with a history of coagulopathy.
8. Women with childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or Depo-provera contraceptive, or barrier plus spermicide); pregnant or breastfeeding mothers.
9. Subjects, who will be unavailable for the duration of the trial, are unlikely to be compliant with the protocol, or who are felt to be unsuitable by the investigator for any other reason.
10. Subjects who are HIV-positive.
11. Subjects who are HBV-positive
12. Subjects who are HCV-positive.
13. Subjects with active CMV
14. Subjects with anemia (Hb \<10.5 gm/dl).
15. Subjects with thrombocytopenia (platelets \<100K/µl).
16. Subjects with lymphopenia (absolute lymphocyte count \<0.7).
17. Subjects with IgG anti-cardiolipin antibody \>16 IU.
18. Prior exposure to anti-CD3 MAb.
19. Known sensitivity to any ingredients in the study drug
20. Any know autoimmune disease except for the studied disorders.
18 Years
75 Years
ALL
No
Sponsors
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NasVax Ltd
INDUSTRY
Hadassah Medical Organization
OTHER
Responsible Party
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Department of Medicine, Hadassah University Hospital, Jerusalem, Israel
Locations
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Hadassah University Hospital, Liver Unit
Jerusalem, , Israel
Countries
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Other Identifiers
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OKT3-NASH-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id
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