Safety and Efficacy of Oral Administration of Anti-CD3 Mo... | NCT01205087

NCT01205087

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
NasVax Ltd	INDUSTRY

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Intervention Names
Placebo	Placebo Comparator	Drug: OKT3
OKT3 - 0.2	Active Comparator	Drug: OKT3
OKT3 - 1	Active Comparator	Drug: OKT3
OKT3 - 5	Active Comparator	Drug: OKT3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OKT3	Drug	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.

Measure	Description	Time Frame
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.		60 days

Measure	Description	Time Frame
This clinical study also will include evaluations for markers of efficacy, as described below.		60 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who have completed the informed consent process culminating with written informed consent by the subject.
Men and women age 18 to 75 years (inclusive)
Patients with biopsy proven NASH within the last 3 years
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.
HBA1C between 5.5 and 14%.

Exclusion Criteria:

Subjects who have undergone surgery within the last 3 months.
Subjects who have had a prior gastrointestinal surgery.
Subjects with a clinically significant infectious, immune mediated or malignant disease
Subjects who are receiving an elemental diet or parenteral nutrition.
Subjects who have been treated with any type of immune modulatory drug including steroids or NSAID within the last 4 weeks
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.
Subjects with a history of coagulopathy.
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.
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.
Subjects who are HIV-positive.
Subjects who are HBV-positive
Subjects who are HCV-positive.
Subjects with active CMV
Subjects with anemia (Hb <10.5 gm/dl).
Subjects with thrombocytopenia (platelets <100K/µl).
Subjects with lymphopenia (absolute lymphocyte count <0.7).
Subjects with IgG anti-cardiolipin antibody >16 IU.
Prior exposure to anti-CD3 MAb.
Known sensitivity to any ingredients in the study drug
Any know autoimmune disease except for the studied disorders.

ID	Term
D016853	Muromonab-CD3
D009853	Omeprazole

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins