Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome

NCT01205087 | Completed Phase 2 DMC

• 1 other identifier: OKT3-NASH-HMO-CTIL
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• This clinical study also will include evaluations for markers of efficacy, as described below.

  60 days

Study Arms (4)

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

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.

Also known as: Omeprazole

OKT3 - 0.2; OKT3 - 1; OKT3 - 5; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• NasVax Ltd: collaborator

Study Sites (1)

Hadassah University Hospital, Liver Unit

Jerusalem, Israel

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Muromonab-CD3; Omeprazole

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Immunoglobulin G; Immunoglobulin Isotypes; Serum Globulins; Globulins; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 23, 2010
• First Posted: September 20, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: April 1, 2011
• Last Updated: June 23, 2011

Record last verified: 2011-06

Locations

IL (1)