Clinical trial NCT01205087: Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome
Official title: Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody in Patients With the Metabolic Syndrome PHASE IIa A Single-blinded Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonalcoholic Steatohepatitis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: NasVax Ltd
First posted: 2010-09-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study is designed to evaluate the safety and immune modulatory effects of oral administration of the study drug anti-CD3 monoclonal antibody (MAb) to subjects with the metabolic syndrome.

Detailed description: PHASE IIa STUDY PROTOCOL A Single-blinded Placebo-controlled Clinical Trial.

Eligibility criteria: Inclusion Criteria:

1. Subjects who have completed the informed consent process culminating with written informed consent by the subject.
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:

1. Subjects who have undergone surgery within the last 3 months.
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.

Primary outcomes:
measure: This clinical study is designed to evaluate the safety and the immune-modulatory effects of oral administration of the study drug anti-CD3 MAb to subjects with the metabolic syndrome.
timeFrame: 60 days
Secondary outcomes:
measure: This clinical study also will include evaluations for markers of efficacy, as described below.
timeFrame: 60 days
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah University Hospital, Liver Unit
Study officials:
References: