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NCT Number: NCT01205087

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

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.

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Key information

Conditions

Nonalcoholic Steatohepatitis Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hadassah University Hospital, Liver Unit

Jerusalem, Israel

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Omeprazole

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.

    Time frame: 60 days

Secondary outcomes

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

    Time frame: 60 days

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Collaborators

  • NasVax Ltd

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Sep 20, 2010
Registry last updated
Jun 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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